ANNEXC5 EUROPEAN COMMISSION TWINNING PROJECTS …amdm.gov.md/sites/default/files/twinning/Final...

ANNEXC5TWINNING FINAL REPORT

EUROPEAN COMMISSION

TWINNING PROJECTSFINAL REPORT

Project Title:Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova asregulatory agency in the field of medicines, medical devices and pharmaceutical activity

Partners:1. Medicines and Medical Devices Agency of the Republic of Moldova,

2. Ministry of Health of the Republic of Lithuania,3. State Medicines Control Agency under the Ministry of Health of the Republic of Lith ania,4, Office for Registration of Medicinal Products, Medical Devices and Bioci al Products of the

Republic of Poland,5. Central Project Management Agency.

Date: 30 April 2019

Twinning Contract number: CTR CRIS 2016/379970


General instructions

1. Overview

The Final Report for the project comprises the following parts:

Section 1 Basic data on the projectSection 2 Content: Achievement of mandatory resultsSection 3 Expenditure: final financial report

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2. General guidance

® Final report shall be submitted no later than three months after the implementation period(work plan) as defined in article 2 of the General conditions of the Twinning Contract (AnnexA2) and at least before the end of the legal duration,

o Final report covers both substance and Finances. The final financial report must beaccompanied by an expenditure erification report from a recognised, independent auditor,following the template in Annex A6 to the Twinning contract.

« The MS Project Leader in co-operation with the BC Project Leader will jointly prepare, co-signand submit the final report to the concerned authority (see 6. of the Twinning manual),

e One copy of the Report must be sent at the same moment to the relevant Twinning Team inthe Commission Headqua ters, as a matter of information. Please see exact requirements forsubmission ofthe Final Report in section 6.4 of the Twinning Manual.

® The Repo t must be submitted in one of the following three languages: English, French orGerman.

3. Notice

The views expressed in this report do not necessarily reflect the views of the EuropeanCommission

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Twinning Contract number; CTR CRIS 2016/379970

Section 1: Project data

Twinning Contract Number CTR CRIS 2016/379970

Project Title:Strengthening of the Medicines and Medical Devices Agency

of the Republic of Moldova as regulatory agency in the field ofmedicines, medical devices and pharmaceutical activity

Twinning Partners (MS and BC) MS: Ministry of Heal h of the Republic of Lithuania;State Medicines Control Agency under the Ministry of

Health of the Republic of Lithuania;Office for Registration of Medicinal Products, Medical

Devices and Biocidal Products of the Republic of Poland;Central Project Management Agency.

BC: Medicines and Medical Devices Agency of the Republic ofMoldova

Duration of the project: 11 January 2017 - 0 March 2019

MS Projec leader:

Mr. Gintautas Barcys, MS Project Leader, Director of the StateMedicines Control Agency under the Ministry of Health of the

Republic of Lithuania

Dr. Grzegorz Cessak, Junior MS Project Leader, President ofthe Office for Registration of Medicinal Products, MedicalDevices and Biocidal Products of the Republic of Poland

BC Project leader:

Mr. Dumitru Saghin, BC Project Leader, Vice Director of theMedicines and Medical Devices Agency of the Republic of

Moldova

Written by:Ms. Anzelika Oraite, the Resident winning Adviser

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Twinning Contract number: CTR GRIS 2016/379970

2 Section: Conten

This section describes the activities of the project. It is divided in nine sub-sections.

LIST OF ABBREVIATIONS

2A - EXECUTIVE SUMMARY2B-BACKGROUND2C - IMPLEMENTATION PROCESS2D - ACHIEVEMENT OF MANDATORY RESULTS2E - IMPACT2F - FOLLOW-UP AND SUSTAINABILITY2G-CONCLUSIONS2H - FINAL RECOMMENDATIONS21-ANNEXES

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Twinning Contract number: CTR CRiS 2016/379970LIST OF ABBREVIATIONS

ADRBEMABCCACHMPCNAMCPCPCHCPMA

Adverse Drug ReactionBenchmarking of European Medicines AgenciesBeneficiary Country Project LeaderCompetent AuthorityCommittee for Human Medicinal ProductsNational Health Insurance Fund of the Republic of MoldovaCentralized ProcedureCentralized Procurement Centre for Health of the Republic of MoldovaCentral Project Management Agency

DCPEDQMEMAEUEUDFSCAGCPGEONGDPGGPGMPGPPGVPGxP

Decentralised ProcedureEuropean Directorate for the Quality of Medicines & HealthcareEuropean Medicines AgencyEuropean UnionDelegation of the European Union to the Republic of MoldovaField safety corrective actionsGood Clinical PracticeGeneral European Official Medicines Control Laboratories networkGood Distribution PracticesGood Governance PracticesGood Manufacturing PracticesGood Pharmacy PracticesGood Vigilance PracticeMay be used instead of GDP GMP, GCP and GVP

HCPICH

Health care professionalInternational Conference on Harmonisation of Technical Requirements

IMPDfor Registration of Pharmaceuticals for Human UseInvestigational medicinal product dossier

ITIWPJMSLQCM

Information TechnologyInspectors Working PartyJunior Member StateLaboratory of Quality Control of Medicines of the Medicines and MedicalDevices Agency of the Republic of Moldova

LMSMMDAMoHMoHLSP

Leading Member StateMedicines and Medical Devices Agency of the Republic of MoldovaMinistry of Health of the Republic of LithuaniaMinistry of Health, Labour and Social Protection of the Republic ofMoldova

MAHMRPMSPLNAPHOMCLPAESPAO

Marketing Authorization HolderMutual Recognition ProcedureMember State Project LeaderNational Agency on Public Healthcare of the Republic of MoldovaOfficial Medical Control LaboratoryPost-Authorisation Efficacy StudyProgramme Administration Office

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PASSPhVPIC/S

PRACPSCPSURRANRMPRTASCSMCA

SOPSARWGWHOURPLWMiPB

Post-Authorisation Safety StudyPharmacovigilanceharmaceutical Inspection Convention and Pharmaceutical Inspection

Co-operation SchemePharmacovigilance Risk Assessment CommitteeProject Steering CommitteePeriodic safety update reportRapid Ale t NotificationsRisk-management planResident Twinning AdvisorSteering CommitteeState Medicines Control Agency under the Ministry of Health of theRepublic of LithuaniaStandard Operating ProcedureSuspected Adverse ReactionWorking GroupWorld Health OrganizationOffice for Registration of Medicinal Products, Medical Devices andBiocidal Products of Poland

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2A - EXECUTIVE SUMMARY

(Leave writing this summary until you have completed ail the other parts of the report]Briefly cover the following items: What was the purpose? To what extent has it been achieved? Whatimpact is it likely to have on the Beneficiary Country administration?

The Twinning Project aimed at implementation of the EU acquis in the area of medicinal productsand medical devices and preparation of the MMDA for joining the EU regulatory agencies network asan equal partner.

The purpose of this project was to strengthen the functioning of the MMDA with regards to clinicaltrials, marketing authorisation, manufacturing and distribution authorisation, vigilance, pricing anddistribution of medicinal products and medical devices, authorisation of pharmaceutical activity aswell as supervision and reinforcement It was presumed that the completion of the project shoulddeliver the MMDA with capacities at the same level as peer institutions in the EU Member States.

This has been achieved through successful implementation of the planned Twinning activities as wellas implementation of the additional missions. Partners f om Lithuania and Poland providedextensi e support to the MMDA through theoretical and practical trainings, workshops, assistanceand recommendations on how to align national legislation to EU acquis and how to apply it inpractice.

The mandatory results have been achieved. As a result of 26 months of the implementation of theproject activities, with the help of the 54- S Es from Lithuania and oland the MMDA has significantlydeveloped its institutional and organisational capacities as a competent authority for medicinalproducts and medical devices. As well, two Memorandums of understanding have been signed amongthe SMCA, the MMDA and the URPLWMiPB which allows further cooperation among peerinstitutions.

2B¦BACKGROUND

Starting PointBriefly describe the original situation in the relevant area of the BC administration before the project,indicating the gaps that the project had to address.

On 1 July 2016, the Association Agreement (AA) between the European Union and the Republic ofMoldova fully came in o force, following ratification by all 31 signatories.

According to Article 113 of the AA, the Parties agreed to develop their cooperation in the field ofpublic health, with a view to raising the level of public health safety and protection of human healthas a precondition for sustainable development and economic growth. Acco ding to Article 115 (a) ofthe AA, the cooperation shall enable the progressive integration of the Republic of Moldova into theEuropean Union's health related networks. According to Article 116 of the AA, Moldova shall carry

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out approximation of its legislation to the EU acts and international instruments referred to in AnnexXIII to this Agreement.

The Medicines Agency was established in accordance with Government Decision No. 617 of 28 June2005 "On the recovery of pharmaceuticals situation in the Republic of Moldova", by reorganising theNational Institute of Pharmacy, the Pharmaceutical Inspection and Pharmaceuticals Department ofthe Ministry of Health. The Agency was subordinated to the Ministry of Health of the Republic ofMoldova and aimed to implement the Ministry of Health s policies in the field of medicinal products,medical devices and pharmaceutical activity.

The roles and responsibilities of he A ency have expanded since 2005. A Road Map for Medicinesand Medical Devices was approved by the Government Decision No. 28 of 11.04.2012 for the years2012 - 2014. The Road Map set out a strategic vision for the operation of the Medicines Agency overthe two-year period from 2012 to 2014. The Medicines Agency was reorganized in the Medicines andMedical Devices Agency (MMDA), through Government Decision No.71 from 23.01.2013.

Until 10 October 2016 the MMDA was a component authority for: a) marketing authorisation formedicinal products; b) pharmaceutical authorisation; c) medical devices; d) clinical trials withmedicinal products; e) authorisation of pharmacies and enforcement of GPP.As well, the MMDA vested functions in the inspection of compliance with GMP, GDP and GCP;centralised procurement of medicinal products and medical devices as well as pricing andreimbursement of medicinal products and medical devices.

On 10 October 2016 the Governmental Decision No 1128 on the Centralized Procurement Centre forHealth of the Republic of Moldova was adopted. The Centralized Procurement Centre for Health ofthe Republic of Moldova was appointed as the central procurement authority responsible forplanning and carrying out the public procurement procedures for medicines, medical devices,specialized medical transport, medical device maintenance services, as well as for evaluating andsupervision of the execution of contracts for healthcare needs.

Economics and history of MoldovaThe Republic of Moldova is a low-income country and comprises with a relatively small populationand small market for the global medicinal products and medical devices industry. Due to historicalas well as economic reasons, most medicinal products are imported from non-EU countries likeRussia and Ukraine. There is also a considerable direct import of generics from countries like Chinaand India. Therefore, many products that do not comply with EU standards were on the market ofthe Republic of Moldova before the Project.

Registration of medical devicesMany of the medical devices that have been used were imported outside the European EconomicArea's market and thus have not been certified by the EU notified body and consequently CE-marked.Alte native approaches have been developed by the MMDA to regulate these medical devices. Thishas led to a registration system of medical devices.

Procurement of medicines and medical devicesThe lack of available affordable EU compliant medicinal products and medical devices has beenreason to allow centralised procurement of those products from markets that do not comply with EUstandards, sometimes just to avoid shortages.

Other challenges for the BC institutionsThe Ministry of Health and the MMDA in many respects had faced a lac of human resources and

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were unable to source in all desirable expertise required to build a strong Agency. One of the mainreasons - he gap between the private sector and overnmental sala ies. Prior the Project the numberof staff members was 145 FTE where budget was available for 170 FTE.

Prior the Project there was a lack of understanding of the EU acquis in terms of medicines andmedical devices and the way it has to be applied in practice. As there was no experience in using theEU legislation in practice, it was difficult for the Ministry and the MMDA to draf national legislationin accordance with EU requirements as well as implement it and work in day-to-day practice.

Objectives

List the objective, purpose and mandatory results of the project (as stated in the Work Plan and / oramended during implementation), addressing the gaps identified above.

Overall Objective Full and correct implementation of the EU acquis in the area ofmedicinal products and medical devices and preparation of theMedicinal products and the Medical Devices Agency for joining the EUregulatory a encies network as an equal partner.

Project Purpose Strengthening of the functioning of the MMDA with regards to clinicaltrials, marketing authorisation, manufacturing and distributionauthorisation, vigilance, central procurement, pricing,reimbursement and distribution of medicinal products and medicaldevices, authorisation of pharmaceutical activity as well assupervision and reinforcement.

Component 1

Approximation of the legalframework andstrengthening of • theMMDA s institutional andorganisational capacities.

The legal framework approxima ed to the EU requirements and theMMDA s institutional, as well as organisational capacitiesstrengthened:

1. Analytical report on current and draft legislation, includingrecommendations for improvement, is provided;2. Training sessions EU regulatory practice at a basic level have beenheld;3. Benchmark report for the MMDA against peer organisations in theEU is provided;4. Report and action plan on the decision-making procedures in theMMDA is provided and approved by the MMDA.

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Component 2 MMDA's regulatory functioning with respect to medical productsstrengthened:

Strengthening of theMMDA s regulatoryfunctioning with respect tomedicinal products.

1. A SOP is developed for marketing authorisation procedure formedicinal products and approved by the MMDA;2. Training sessions on EU regulatory affairs and assessment ofmedicinal products have been held;3. Risk based enforcement system developed and approved by theMMDA;4. at least 5 MMDA members trained for inspections in respect ofGMP, GDP, GVP;5. Recommendations for Pharmacovigilance Unit given and trainingfor sepa ate targeted groups provided;6. A SOP for clinical trials authorisation is developed;7. Training of staff on clinical trials authorisation completed;8. 8 MMDA members have completed its training in the winningpartner's work environment.

Component 3 1. The MMDA will be provided with guidelines for the SOP onregulation of medicinal devices.

Strengthening of theMMDA s regulatoryfunctioning with respect tomedical devices.

2. Training on medical devices regulatory affairs has taken place.3. In o der to strengthen the capacities of MD department, analyticalreport on MD vigilance will be provided.4. To the MMDA staff will be offered additional, practical dimensionof training by taking part in the study visit at the beneficiary s countryauthority.

Component 41. Analytical report in respect of improvement of availability andaccess provided including action plan to be approved by the MMDA;2. Analytical report and recommendations in respect of enfo cement

Improvement of rationaluse of medicines andmedical devices.

provided and at least 4 inspectors trained (GMP, GCP and GDP];3. Analytical report and recommendations and action plan onpromotion of medical product provided and enforcementenvironment developed.4. Strategic document provided, conferences on rational useorganised and information modules for the general public developed.5. Report on enforcement of Good Pharmacy Practice provided andGPP inspectors trained.

Component 51. At least 4 assessors trained and introduced to the EU network;2. The current system evaluated and an analytical re ort on GoodGovernance provided;

Transition of the MDDA tofull compliance with the EUrequirements

3. Analytical report with recommendations and action plan about thePharmaceutical Quality Control laboratory provided for nationalimplementation approved by the MMDA;4. Analytical report and report with the recommendations on themanagement of the medicinal products market during thetransitional period provided and a proved by the MMDA;5. Training of the assessors regarding EMA and its working groupscompleted.

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2C - IMPLEMENTATION PROCESS

Developments outside the project(a) What were the key developments in the relevant policy area in the Beneficiary Country during theimplementation of the project? Which of the original assumptions of the project (Article 3 of the WorkPlan) were fulfilled?(b) What external problems threatening smooth implementation of the project appeared and how werethey solved?

At the first stage, the Beneficiary of the EU-funded Twinning Project was the MMDA and all theactivities foreseen in the Annex A1 were addressed to the MMDA. However, during theimplementation of the EU-funded Twinning Project, the number of beneficiary institutionssubstantially increased due to policy changes in the Republic of Moldova. Institutions like Ministry ofHealth, Labour and Social Protection of the Republic of Moldova, National Agency on MedicalInsurance of the Republic of Moldova, Centralized Procurement Centre for Health of the Republic ofMoldova, National Agency for Public Healthcare of the Republic of Moldova and other relevantinstitutions were actively involved in the activities of the Twinning Project together with the MMDA,which remained the main Beneficiary institution and the recipient of the Action.

It is also worth mentioning that at the beginning of the EU-funded Twinning Project, the MMDA wassubordinated to the Ministry of Health of the Republic of Moldova. Later, during the implementationof the EU-funded Twinning Project, the status of the MMDA has changed. Now MMDA is a publicauthority, under the subordination of the Government? in acc. with the amendments made on 4 April2017 to the Article 91, Chapter 1, of he Law on the Pharmaceutical Ac ivity No. 1456 from 25 May1993.

During the project implementation, the Ministers of Health were changed 4 times. At the beginning,the Minister of Health was Ms. Ruxanda Glavan. Then, according to the Decision of the Parliament ofthe Republic of Moldova No. 189 as of 21 July 2017 on approving the list of ministries, the Ministryof Labour, Social Protection and Family took over the domains of activity from the Ministry of Health,with the modification of its name to the Ministry of He lth, Labour and Social Protection of theRepublic of Moldova. The Government of the Republic of Moldova, within 3 months, reorganized thestructure of the central specialized bodies of the public administration according to the provisions ofthe present decision, and brought its normative acts in accordance with the decision. As a esult, on26 July 2017 Ms. Stela Grigoras was appointed as the Minister. On 10 January 2018, Ms. SvetlanaCebotari was named by the Government as the new Minister of Health, Labour and Social Protection.On 25 September 2018, Ms. Silvia Radu was named by the Government as the new Minister of Health,Labour and Social Protection.

During the 4th quarter of the project implementation, the former Deputy Minister, Ms. Liliana lasan,who was involved in the Twinning Project, was dismissed. As well, Ms. Maria Lapteanu, the Head ofhe Medicines and Medical Devices Department, who was appointed by the former Deputy Minister

to represent the MoHLSP in all the aspects related to the Twinning Projec , left her job. A letterrequesting for an official appointment of a representative of the Ministry for the Twinning Projecthas been sent to the MoHLSP by the RTA. As a result, Ms. Rodica Scutenic, the State Secretary wasappointed to be the contact person from the MoHLSP for the Twining Project. For theimplementation of the EU-funded Twinning project it took additional time to re-establish each timethe responsible representatives from the MoHLSP as well to coordinate the future Twinningactivities.

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On 9 September 2017 the Government of the Republic of Moldova approved the Decision No. 705 onestablishment of the National Agency on Public Healthcare and reo ganization of some entities. TheNAPH is a public authority under the MoHLSP. The functions of pha maceutical control and medicaldevices control were attributed to the NAPH. It took several months for the Government of theRepublic of Moldova to approve the institutional chart and the state of staff of the NAPH as well asfor the institution to become operational. Only in June 2018, 2 inspectors in respect of the control ofpharmacies were hired at the NAPH. This resulted in delays for the implementation of some Twinningactivities as according to the Twinning contract 2 activities were addressed to the pharmacyinspectors as well as the enforcement of GPP: Activity 4.5 Strengthening of supervision of pharmaciesand enforcement ofGPF' and Activity 4.6 "Study visit related to Component 4".

Additionally, substantial changes in the MMDA occurred. On 12 of March 2018, the new InstitutionalChart of the MMDA entered into force, according to the Governmental Decision No. 220 as of 12Ma ch 2018 on modification of the Annexes No 1, No. 2 and No. 21 the Governmental Decision onapproval of the Regulation, Structure and Staff Limit of the MMDA No. 71 as of 23 January 2013.According to the new approved MMDA institutional chart, there will be 110 employees instead of159. As well, the functions related to good manufacturing practice (GMP), good distribution practice(GDP), good vigilance practice (GVP) and registration and placing on the market of medical deviceshave been attributed to the MMDA.

During the Ac ivity 1.1 missions considerable time has been attributed to the revision of theMoldavian pharmaceutical legislation against EU acquis. In carrying the revision, around 30 bindinglegal acts have been evaluated. Considering that many provisions of the Directive 2001/83/EC werenot transposed into the Moldovan legislation and in order to contribute in elaboration of legalrequirements in accordance with the EU acquis the Draft Law on Medicines of the Republic ofMoldova has been reviewed and the recommendations together with the comparative tablesprovided. During the 8th SCM the representative of the MoHLSP informed that due to some issues aswell as the upcoming elections to the Moldavian Parliament, the Government of the Republic ofMoldova decided to postpone the submission of the Draf Law on Medicines for the Parliaments approval. According to the Action Plan 2019 of the MoHLSP, the Draf Law on Medicines mus besubmitted by the MoHLSP for approval to the Government within the 4th quarter of the 2019.

In December 2018 the changes in the mana ement of the National Health Insurance Fund of theRepublic of Moldova occurred. Instead of Mr. Dumitru Parfentiev, Ms. Tamara Andrusca has beenappointed as a new Director General of the CNAM.

On 24 February 2019 the Parliamentary elections were held in the Republic of Moldova. Preliminaryresults were communicated by the Central Electoral Commission and the electoral process will beconcluded once the Constitutional Court has validated the final outcome.

Original assumptions of the EU-funded Twinning project (listed below) were fulfilled.

Project assumptionsStable political and economic development in the Republic of Moldova with continuous approachto the EU access; Full commitment of all institutions involved;Good collaboration amon relevant institutions;Support by the hi hest mana ement in all relevant institutions;Adequate commitment and capability of all relevant stakeholders;

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Adequate BC experts appointed to participate in trainings established.

Project developments

(a) Describe the key developments inside the project, such as change of key staff, re-orientation,completion of an important packa e of activities, other turning points. (NB: Do not make a detailedaccount of all activities here)(b) What internal problems threatening the implementation of the project appeared, and how were theysolved?

The overall objective of the Project is full and correct implementation of the EU acquis in the area ofmedicinal products and medical devices and preparation of the Medicines and the Medical DevicesAgency for joining the EU regulatory agencies network as an equal partner. To this respect ProjectPartners mostly focused on the approximation of the Moldavian legal framework against EU acquis;strengthening the MMDA institutional and organisational capacities; strengthening the MMDAregulatory functioning with medicinal products and medical devices; improvement of rational use ofmedicines and medical devices as well as preparation of the MMDA to operate as an equal partnerwith EU regulatory agencies.

Starting from March 17, 2017 the per diem rate for the Republic of Moldova has been reduced from171 EUR per night to 139 EUR, therefore, it allowed to finance several ad itional STEs missions uponrequest of the MMDA. Those included additional missions for the MMDA PhV and CT staff, trainingon medical devices for MMDA and stakeholders as well as strengthening of the MMDA Quality Cont olLaborato y capacities. As a result, a significant number of BC staff, healthcare professionals and otherstakeholders were able to benefit from the Twinning activities.

Most significant achievements of the Twinning Project:1. Following the analysis of the Moldovan legal framewor on medicinal products and medicaldevices, the STEs provided a number of screening and comparative tables against EU Directive2001/83/EC and elaborated series of recommendations in the context of the Draft Law onMedicines as well as the Law on Medical Devices. As a result, following the STEs recommendationsthe Draft Law of Medicines has been substantially improved and according to the Action Plan of theMoHLSP 2019 shall be submitted for the approval within the 4th quarter of the 2019.

2. In the field of medicines, medical devices and pharmaceutical activity the capacity of theBeneficiary Country institutions has been significantly improved i.e. about 900 attendees attendedthe Twinning activities (trainings, conferences, workshops, working meetings], a substantiationnumber of SOPs and other MMDA internal acts have been officially approved by the MMDAmanagement following the STEs recommendations. As well, several joint inspections in respect ofGMP, GDP, GCP, GVP and GPP were conducted in the Republic of Moldova, the Republic of Lithuaniaand the Republic of Poland where BC inspectors were trained in inspection process following the EUand national requirements.

3. Pharmacovigilance and regulatory awareness in the medical and pharmaceutical community havebeen raised by organising several trainings to the MMDA staff as well as organising the ConferenceAdverse Drug Reaction Reporting and Rational Use of Medicines and Medical Devices: Challenges andBest Practice with the main purpose to raise the awareness of adverse drug reaction reporting andrational use of medicines and medical devices. The training was attended by more than 100

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representatives from healthcare institutions and patient organisations. Posters on raising awarenessand promoting the adve se d ug eaction reporting were elabo ated and distributed to thehealthcare institutions by the MMDA staff. Following the measures undertaken by the BC andTwinning Partners, the number of adverse reactions reporting increased from 556 to 946 during the2018 year.

4. On July 9, the Quality Control Laboratory of Medicines has been attested by the Europeandirectorate for the Quality of Medicines and Healthcare, which declares that it has satisfactorilyimplemented a Quality Management System in accordance with ISO/iEC 17025, with the relevanttexts of the European Pharmacopeia, with the Quality Managemen Guidelines and the Terms ofReference od the General European OMCL Network. The attestation is valid until January 2022. Withthe successful completion of the MJA13/17, the Quality Control Laboratory of Medicines is confirmedas a full member of the General European OMLC Network (GEON). In total, more than 30 documentshave been updated/drafted and officially approved following the STEs recommendations. As well, on8 October 2018 the Laboratory was among the top five of 123 laboratories that participated in theinter-laboratory tests organized by the EDQM.

5. The MMDA carried out the Be chmarking of European Medicines Agencies (BEMA) self-assessment which has been followed by the BEMA audit simulation carried out by the professionalBEMA auditors. The main aim of the BEMA is to contribute to the development of a world-classmedicines regulatory system based on a network of agencies operating to best practice standards. Asa result, the BEMA auditors concluded that the MMDA is well governed and appropriately preparedin terms of scientific and regulatory knowledge to carry out activities as National CompetentAuthority for medicinal products.

Twinning Contract Modifications:1. Addendum

On October 30 the Amendment No. 1 to Twinning Contract was submitted to the EUD. The purposeof this amendment to the Twinning contract was to:

• Annul the Amendment No. 1 submitted to EU Delegation to the Republic of Moldova on 20 August2018;

• Extend the implementation period of the Action with 2 additional months (last day 10 March);• Prolong the implementation period of this Activities:

- 0.3 Steering Committees" with 3 w/d for MS PL and JPL,2.5 Improving pharmacovigilance by reaching out to the medical and pharmaceuticalcommunity with 5 w/d for 2 STEs,1.2 Training of staff on the EU regulatory framework for medicines and medical devices (formedical devices) with 3 w/d for 1STE,

- 4.6 "Study Visit" with 5w/d and,- 5.4 "Management of the medical products market during the transition with 5 w/d.

• Update the project time schedule for implementation of the activities;• Adapt and update the project budget as needed for implementing the changes envisaged by this

Amendment

According to the Twinning Contract, the implementation period of Twinning Project is 11.01.2017-10.01.2019. On December 3, 2018 during the second reading the Law on the Ratification ofAddendum No. 3 to the Financing Agreement between the Government of the Republic of Moldovaand the European Union on the Framework Program for Supporting Cu rent and Future Agreementsbetween the Republic of Moldova and the European Union has been adopted, which is the legal base,

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together with the Amendment No. 1 to Twinning Contract to extend the implementation period ofTwinnin Project with 2 months. On 21 December 2018, the above-mentioned Law has beenpublished in the Official Gazette and entered into force.

2. Side Lettersin total, 22 Side letters to the Twinning Contract co-signed by the BC Project Leader and the RTA havebeen approved by the EUD. Those inter alia included changes in the per diem rates, expansion of thePool of STEs, changes in the BC Human resources, increasing the number of STEs missions.

Project visibility

(a) What steps were taken to ensure project visibility and EU visibilit and what was the influence onthe project implementation process?

The EU-funded Twinning team has conducted Project visibility and communication activities inaccordance with the requirements of the Communication and Visibility Manual for EU ExternalActions. Prior the beginning of the Project implementation period a Communication and VisibilityPlan has been developed and approved by the stakeholders.

Project visibility was constantly ensured during the project, using various tools:

- Organisation of the Kick-Off Conference, with pa ticipation of EU officials, ambassadors ofthe MS providing the assistance, Moldovan representatives of public authorities, medicalsector and mass-media representatives. The purpose of the event was to provide to the mediaand to all interested parties with the essential information regarding the Twinning projectand its objective;

- Organization of the Closing event, with participation of EUD officials, H. E. Ambassador of theRepublic of Poland to the Republic of Moldova, representatives of the Embassy of the Republicof Lithuania to the Republic of Moldova, Moldovan representatives of public authorities,medical sector and mass-media representatives, with the purpose to provide to the media andto all interested parties with the essential information regarding the Twinnin project andattained results;

- On 11 August 2018 in Warsaw two Memorandums of Understanding were signed: theMemorandum of Understanding between the MMDA and the SMCA in the field of Cooperationof Medicinal Products, and the Memorandum of Understanding between the MMDA and theURPLWMiPB on Cooperation in the field of Medicines and Medicinal Devices. Parties agreedto deepen and enhance cooperation in the area of medicinal products for human use, toexchange information and experts visits, including exchange information and experts in thefield of marketing authorisation of medicinal products, as well as information on qualitycontrol of medicinal products. Additionally, the Parties will exchange experience of goodmanufacturing practice and good distribution practice, including the possibility of performingjoint inspections, organizing study visits and joint workshops and trainings of inspectors;

- Organisation and participations in several International Meetings in Poland and Lithuaniawhere Project Partners discussed possible further dimensions of triple Lithuanian, Polish andMoldavian co-operation based on the advanta e of the Twinning project outcomes. During themeeting partners exchanged the experience, identified most crucial and attention demandingfields of mutual effort in seek of availability of safe and efficacious medicinal products andmedical devices for patients in partner countries;

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- The book "100 Years of Drug Registration in Poland - 200 Years of the Polish Pharmacopoeia"containing basic information about the Twinning projec and photos was printed by PolishCompetent Authority to celebrate the Jubilee Conference "100 Years of Drug Registration inPoland, 200 Years of the Polish Pharmacopoeia";

- Participation of the RTA and RTA assistants in t o European Village Events (2017 and2018), organized by the EUD, sharing to the public information on the EU-funded Twinningproject through visibility items and interviews;

- Through the special section c eated on the MMDA website section where generalinformation on the Twinning project in RO and EN languages, for. e.g., objectives, activities,mandatory results, contact details of the Twinning Team, implementation progress, achievedresults, followed by the photos were accessible to the general public and the targetedpopulation in the BC;

- Press releases on the main achievements and meetings held are published on the SMCA andthe URPLWMiPB official webpages (in EN, LT and PL languages);

- Organization, within the Twinning framework, of nine Quarterly SC meetings with theparticipation of the representatives of the EUD, MMDA, MoHLSP, Ministry of Finance, CNAM,CAPCS, NAPH as well as MoH, SMCA and URPLWMiPB;

- On October 10, the Conference Raising Awareness of the Adverse Drug Reaction Reporting andRational Use of Medicines and Medical Devices - Challenges and Best Practice", commonlyorganized by the Ministry of Health, Labour and Social Protection of the Republic of Moldova,the Medicines and Medical Devices Agency of the Republic of Moldova and the EU-fundedTwinning Project took place. The main purpose of the Conference was to raise the awarenessof adverse drug reaction reporting and rational use of medicines and Medical Devices. Theevent was attended by more than 100 attendees from the BC and was broadly disseminatedthrough the local and national media;

Visibility items were produced and disseminated to the BC staff who participate in the EU-funded Twinning project activities. The banners served as a backdrop for the Opening andClosing events as well as 9 Steering Committee Meetings and all STEs missions and eventsorganised within the Project in Moldova.

- The RTA participated at several Health Sector Coordination Council Meetings in the field ofExternal Assistance organized by the Ministry of Health, Labour and Social Protection of theRepublic of Moldova, as well as the meetings organized by the WHO. The scope of the meetingswas to update on progress of technical assistance in the field of health;

- The RTA participated at the RTAs meetings organized at the EU Delegation, in order to ensurecoordination between the different projects.

Twinning Contract number: CTR CR1S 2016/379970

2D - ACHIEVEMENT OF MANDATORY RESULTS

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(a) Describe the extent to which each of the mandatory results (measured against the benchmarksagreed in the Work Plan) wa achieved.(b) In case one or more mandatory results were not entirely achieved, explain why.(c) Overview mandatory results achieved (See Annex 1).

Mandatory Results and ;e chmarks (as in Log

' rame] -. -

Achievement f

Component 0: Visibility eventsActivity 0.1. Installation and Kick-off Conference

e Kick-off meetingorganized, visibility planand part of visibility andprojec promotionmaterials prepared;

• Stakeholders and otherinterested partiesinformed of the launch,aims and content of theproject by the end of thefirst month;

• Visibility and projectpromotion materialsprepared.

Activit 0.1 successfully completed and the result achieved.The Kick - off Conference was jointly organised by the Delegation ofthe European Union to the Republic of Moldova, the Medicines andMedical De ices Agency of the Republic of Moldova, the StateMedicines Control Agency under the Ministry of Health of theRepublic of Lithuania and the Office for Registration of MedicinalProducts, Medical Devices and Biocidal Products of the Republic ofPoland.

The objectives of the Kick-off, namely, to provide a first officialcontact to the project stakeholders, to get to know each other as wellas to present the project objectives, deliverables, activities, workingplans and expected results were successfully achieved.

he Kick-off meeting was attended by the high-level stakeholders andother interested parties as well as the mass media.

Representatives from the Parliament of the Republic of Moldova,Ministry of Health of the Republic of Lithuania, Ministry of Health ofthe Republic of Moldova, European Union Delegation to the Republicof Mol ova, Embassy of the Republic of Poland to the Republic ofMoldova, Embassy of the Republic of Lithuania to the Republic ofMoldova, World Bank/ Office of World Health Organization inRepublic of Moldova, American Chamber of Commerce in theRepublic of Moldova, Office for Registration of Medicinal Products,Medical Devices and Biocidal Products of the Republic of Poland,Association for support of national medicines fabricants, NationalAgency for Food Safety of the Republic of Moldova, TechnicalUniversity of the Republic of Moldova, National Medical InsuranceCompany, Municipal Directorate of Health of Chisinau municipality,Centralized Procurement Centre for Health of the Republic ofMoldova, Medicines and Medical Devices Agency of the Republic ofMoldova, Oncology Institute of the Republic of Moldova, Mother andChild Institute of the Republic of Moldova, Republican Hospital of theRepublic of Moldova, Institute of Phtisiopneumology of the Republicof Moldova and Scientific Practical Center for Cardiovascular Surgeryof the Republic of Moldova attended the Kick-off conference.In total, more than 50 pa ticipants attended the event.

Representatives of 12 media companies provided press coverage ofthe Kick Off Conference. In order to make the stakeholders and press

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fully aware of the Project and its partners, the detailed presentationfor the participants of the Kick-off meeting has been delivered by theRTA. After the Kick-off meeting the press-release was issued.

The EU-funded Twinning team has conducted Project visibility andcommunication activities in accordance with the requirements of theCommunication and Visibility Manual for EU Exte nal Actions. Priorthe beginning of the Project implementation pe iod a Communicationand Visibility Plan has been developed and approved by thestakeholders. Following the Plan, Visibility and project promotionmaterials prepared and circulated to the stakeholders.Activity 0.2. Final Closing Conference

• Closing conferenceorganised;

• Recommendations andlessons discussed andreported;

e Stakeholders and otherinterested partiesinformed about projectactivities, results andachievements;

• Visibility ensured.

Activity 0.2 successfully completed and the result achieved.The Closing Conference was jointly organised by the Delegation of theEuropean Union to the Republic of Moldova, the Medicines andMedical Devices Agency of the Republic of Moldova, the StateMedicines Control Agency under the Ministry of Health of theRepublic of Lithuania and the Office for Registr tion of MedicinalProducts, Medical Devices and Biocidal Products of the Republic ofPoland.

During the event the main results and achievements of the project aswell as recommendations for future work and follow-up, andcomments on the lessons learned were presented. In addition, thedevelopments at the MMDA and the results of the Twinning projectwere presented and discussed.

The Closing conference was attended by the high-level stakeholdersand other interested parties as well as the mass media.

Representatives from the European Union Delegation to the Republicof Moldova, the Parliament of the Republic of Moldova, Ministry ofHealth of the Republic of Lithuania, Ministry of Health, Labour andSocial Protection of the Republic of Moldova, Ambassador of theRepublic of Poland to the Republic of Moldova, representatives of theEmbassy of the Republic of Lithuania to the Republic of Moldova,Country representative of the Office of World Health Organization inRepublic of Moldova, Office for Registration of Me icinal Products,Medical Devices and Biocidal Products of the Republic of Poland,Technical University of the Republic of Moldova, CentralizedProcurement Centre for Health of the Republic of Moldova, Medicinesand Medical Devices Agency of the Republic of Moldova, as well asother representatives of the healthcare institutions attended theClosing conference. In total, more than 50 participants attended theevent.

The EU-funded Twinning team has conducted Project visibility andcommunication activities in accordance with the requirements of theCommunication and Visibility Manual for EU External Actions.

Activity 0.3. Steering Committee Meetin s

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© Steering CommitteeMeetings organised;© Quarterly reportsprepared and approved.

Activity 0.3 successfully completed and the result achieved.Nine Steering Committee Meetings were organised and nineQuarterly Reports, signed by the MS Project Leader, Junior Ms ProjectLeader and BC P oject Leader have been approved by the Delegationof the European Union to the Republic of Moldova.

The Steering Committee Meetings were jointly organized by theDelegation of the European Union to the Republic of Moldova, theMM DA, the SMCA and the URPLWMiPB, in Chisinau at the premisesof the MMDA.

The objectives of the Steering Committee Meeting namely to reviewthe progress made under the project, as well as to discuss the resultsachieved and/or problems occurred were successfully achieved.

Representatives from the European Union Delegation to the Republicof Moldova, the SMCA, the URPLWMiPB, Ministry of Health, Labourand Social Protection of the Republic of Moldova, Ministry of Financeof the Republic of Moldova, Cent alized Procurement Centre forHealth of the Republic of Moldova, MMDA, National Agency for thePublic Healthcare, National Health Insurance Fund of the Republic ofMoldova and others attended the meetings.

The PSC meetings were used as an additional opportunity toimplement project communication activities and to further increasevisibility of the Twinning activities by distributing visibility materialsmarked with the EU and project logos, presenting the basicinformation on the Project as well as main results and to discuss theissues occurred.

Overall, 9 PSC meetings have been organised, more than 20participants attended each of the PSC meeting.

The 9 Quarterly Reports have been prepared and approved.

Component 1: Approximation of the legal framework and strengthening of the MMDA sinstitutional and organisational capacities.

Activi v 1.1 Approximation of the le al framework• Analysis of Moldovan

legal acts on medicinalproducts and medicaldevices prepared;

• Comparative screeninglist of Moldovan legalacts against the EUACQUIS on medicinalproducts and medicaldevices prepared;

Activity 1.1 successfully completed, and the results achieved.• Analysis of Moldovan legal acts on medicinal products and

medical devices prepared;• Comparative screening list of Moldovan legal acts against the EU

acquis on medicinal products and medical devices prepared;• Legal gaps or inconsistency with the EU acquis identified;• Recommendations for improvement of legislation prepared.

The objective of the first mission of the Activity 1.1 was to acquirethe orientation on the legal framework for the regulation of medicinalproducts for human use, investigational medicinal products andmedical devices in the Republic of Moldova with the view to identify

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e Legal gaps orinconsistency with theEU ACQUIS identified;

© Recommendations forimprovement oflegislation prepared.

the areas where specific focus on the approximation to the EU acquisis necessary and further detailed analysis is required.

The eview of the Moldovan legislation as well as legal gap andinconsistency with the EU acquis analysis in respect the following wasperformed: marketing authorisation of medicinal products,pharmacovigilance, manu acturing of medicinal products, clinicaltrials, medical devices, activities of control laboratory of the MMDA.The objective of the second mission was to scrutinize the legislationon medicinal products of the Republic of Moldova with the view toidentify legal gaps or inconsistency with the EU acquis.

Considering that many provisions of the Directive 2001/83/EC werenot transposed into the current Moldovan legislation and in order tocontribute in elaboration of legal requirements in accordance withthe EU acquis the Draft Law on Medicines of the Republic of Moldovahas been also reviewed.

The comprehensive assessment of the Moldovan legislation and ofthe Draft Law on Medicines as well as scrutiny of legal gaps andinconsistency with the EU acquis in respect the following wasperformed during the second mission: wholesale distribution; statesupervision of manufacturing and wholesale distribution activities;advertising; sale of medicinal products at a distance to the public;labelling of medicinal products; package leaflet; summary of productcharacteristics; classification of medicinal products.

During the third ission, the review of the Moldovan legislation aswell as legal gap and inconsistency with the EU acquis analysis inrespect the following was performed: authorization of medicinalproducts; pharmacovigilance; manufacturing and importauthorisation of medicinal products and investigational medicinalproducts, activities of Control laboratory; clinical trials; identificationof specific areas for further analysis in the drafted legislation.

During the third mission the new amendments to the DL werereviewed as well as the most crucial inconsistencies in respec ofDirecti e 2001/83/EC were highlighted repeatedly.

During the fourth mission the Law on Medical Devices and the DraftLaw on Medicinal Products of the Republic of Moldova as of27.11.2017, including its relation to the EU Regulations were revisedby the STEs.

Also, the amendments made to the Draft Law on Medicinal Productsof the Republic of Moldova as of 27.11. 017 were analysed, evaluatedand commented as well as the main inconsistencies with Directive2001/83/EC were summarised and highlighted.

During all four missions, series of meetings, interview sessions andexperience sharing sessions with the MMDA staff, the epresentatives

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of the National Committee on Ethics Exper ise and with therepresentatives of the MoHLSP have been organized.

During the missions, screening tables against EU acquis and reviewof the Moldavian legislation as well as legal gap and inconsistencywith the EU acquis analysis were performed by STEs.

The Report on the Quality of Moldovan Legislation and ImplementingMeasures with Respect to Medicinal Products, Clinical Trials andmedical Devices was elaborated by the STEs and submitted to theMoHLSP and to the MMDA.

The Draft Law on Medicines was revised taking into considerationthe recommendations provided by the STEs. According to the ActionPlan 2019 of the MoHLSP, the Draft Law on Medicines must besubmitted by the MoHLSP for approval to the Government within the4th quarter of the 2019.

Activity 1.2. Training of staff on the EU regulatory framework for medicines and medicaldevicesAt least 15 staff memberstrained on the EUregulatory framework formedicines and medicaldevices.

Activity 1.2 successfully completed, and the results achieved.In total, more than 45 BC attendees were trained on the EU regulatoryframework for medicines and medical devices.

The aim of the training in respect of clinical trials was to present theMMDA staff the EU regulatory framework for clinical trials ofmedicinal products. Lithuanian STEs have trained the MMDA staff inrespect of principals of Good Clinical Practice and current Directive2001/20/EC

The training course has also contained introduction to mainprincipals foreseen in the Clinical Trials Regulation No 536/2014. Allrelevant processes of the submission, validation and evaluation of theclinical trials applications were covered by the topics of the training.

The aim of the training in respect of marketing authorisation wasto train staff of the MMDA to gain a sufficient knowledge in theprimary evaluation, quality and clinical assessment of the marketingauthorization dossier, drafting of the assessment report. LithuanianSTE also shared the experience of the SMCA in the management of thee-Dossiers. During the training necessary aspects, relating to theprimary evaluation of the marketing authorization dossiers wereaddressed as well as experience in managing national, mutualrecognition or decentralized procedures and managing of the e-Dossiers were provided of the dossiers and drafting of theassessment report.

The aim of the training in respect of Good Manufacturing Practiceand Good Distribution Practice was to train MMDA staff to gain asufficient knowledge in the field of regulation of manufacturefimport] and wholesale dist ibution of medicinal products in the EU

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including licensing of applicants and supervision of holders oflicenses. During the training all planned information about the EUlegislation in the pharmaceutical sector with regard to manufacture,import, wholesale distribution of medicinal products and supervisionof these areas was presented.

The aim of the training in respect of medical devices was to presentthe MMDA staff the EU regulatory framework of medical devices, theMMDA staff have been trained in respect of principals in medicaldevices, by discussing Directives: 90/385/EEC, 98/79/EC,93/42EEC. he training course have also contained introduction tomain principals foreseen in new European Regulations: medicaldevices 2017/745 and in-vitro medical devices 2017/746.

One additional 3-day mission with the objective to provide thetraining course on Regulatory framework for medical devices: EUand the Republic of Moldova was commonly carried out by theexpert from the URPLWMiPB and he experts from the MMDA.

The training course covered information on European Directives andRegulation on medical devices, Moldavian national legislation onmedical devices, the role and obligations of the AuthorizedRepresentative in EU, the notification procedure of medical devices,as well as the vigilance of medical devices in the Republic of Polandand in the Republic of Moldova. Representatives from the publichealthcare institutions, local producers and private importers ofmedical devices attended the training.

More than 95 % of attendees evaluated training on a highest score.

Activity 1.3. Benchmark of functions of the MMDA with EU competent authorities and servicesPrepared benchmark reportcomparing functioning ofthe MMDA with EU agenciesinvolved in the sameprocedures.

Activity 1.3 successfully completed and the result achieved.Several meetings and discussion sessions with the- MMDAmanagement and employees were organised. During the meetingsthe STEs from the SMCA presented the main responsibilities of theSMCA, as well as its functions among the European Economic Area(EEA) agencies. The main similarities and differences between thefunctions and responsibilities of the SMCA and the MMDA wereaddressed and discussed. The importance of the functions and thesubordination/coordination mechanisms was highlighted.

The STEs from he SMCA also presented and shared the results of thesurvey comparing the functions of the MMDA with the 28 EU agenciesinvolved in the same or similar procedures (for e. g, marketingauthorisation of medicinal products, authorisation of clinical trials,GMP, GDP, GCP, GVP inspections, OMCL competence, responsibilities inrespect to medical devices).

The analysis of the current legislation and the draft legislation inrespect to the functions of the MMDA, as well as foreseenreadjustments of the MMDA was made. It was followed by the

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discussions with the experts from the MMDA, as well as themanagement of the MMDA.

The STEs prepared the Benchmark report comparing the functions ofthe MMDA with the EU agencies involved in the same procedures,which is based on the collection of the information through theinterviews, discussions with the MMDA staff, fact findings, theanalysis of the information and the relevant documents, surveys,compa ison of the functions, as well as he comparison of the currentand the draft legislation.

Activity,1.4, Analysis of the decision makin roceduresReport on the decisionmaking procedures for thedifferent tasks of the MMDAincluding action plan forimprovement (if needed).

Activity 1.4 successfully completed and the results achieved.The STEs from the SMCA presented the decision-making process inthe SMCA and the role of the Quality management system of the SMCAin the decision-making procedures/processes.

The review of the current legislation and draf legislation in respectto the decision making of the MMDA was conducted and followed bythe discussions with the experts from the MMDA.

The STEs from the SMCA analysed the decision-making procedures inthe MMDA. Interview sessions with the MMDA employees wereorganised.

Based on the interviews and discussions with the MMDA staff, thepresentations, fact findings, comparison of the decision makingprocedures within the SMCA and the MMDA, the analysis of thecollected information and the relevant documents, and the outcomeof the review on the cur ent and the draft legislation of the Republicof Moldova, the STEs from the SMCA prepared the action plan inwhich the recommendations on the improving of the decision makingprocess were made.

The Report on the Decision-Making Procedures for the DifferentTasks of the Medicines and Medical Devices Agency of the Republic ofMoldova including Recommendations and Action Plan was preparedand presented to the MMDA. Following the Recommendationsprovided for in the Report, internal changes have been implementedwithin the MMDA.

Component 2: Strengthening oftheMMDA s regulatory functioning with respect to medicinalroducts.

Activity 2.1. Development of an SOP for the authorisation of medicinal products includingbuilding the infrastructure for risk benefit assessment and robust and independent decision

makingSOP for the authorisation ofmedicinal productsincluding building theinfrastructure for risk

Activity 2.1 successfully completed and the result achieved.During the missions, the STEs from SMCA acknowledged with theSOP s in regard to Repeated Authorization and Post-authorizationvariations activities approved within the MMDA, analysed

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benefit assessment androbust and independentdecision making developed.

information and documents. After deep analysis of the receivedinformation, STEs elaborated the SOP project for the MarketingAuthorization and Renewal, and the SOP project for the Post¬authorization variations activities.

In addition, the SOP for Post-Authorization Variations has beendeveloped by STEs and delivered to the MMDA.

Both, the Standard Operating Procedure for Initial MarketingAutho ization and Renewal of the Medicinal Products, as well as theStandard Operati g Procedure for Post-Authorization Variations ofthe Medicinal Products were approved by MMDA Director General on12 March 2018.

The SOP for post-authorization variations of the medicinal productswas approved as a separate procedure:1. validation procedure of the dossier has been included at thesubmission of applications stage;2. assessment sheet C01.SOP-02:F01 for post-authorizationvariations dossier was elaborated;3. register for evidence of the variations C01.SOP-02:Rg03 wasintroduced.

The approved Standard Operating Procedure for Initial MarketingAuthorization and Renewal of the Medicinal Products is a synthesisof the previously existing 6 procedu es, so at the moment the wholeapproval process of medicines products has a continuity from thesubmission of the application to the completion of the authorizationprocedure (recommendation of the twinning experts):1. validation of dossier procedure was introduced;2. assessment sheet C01.SOP-01:F01 for the submitted dossier waselaborated;3. register for the validation of applications C01.SOP-01:Rg01 wasintroduced;4. some steps of the authorization p ocedure have been modified inaccordance with the recommendations of the Twinning projectexperts;5. assessment reports for the dossier for pharmaceutical, non-clinicaland clinical part, elaborated in accordance with EMEA C MP D70Assessment Report Templates-CIinical; EMEA CHMP D70 AssessmentReport Templates - Quality; EMEA CHMP Day 80 Critical AssessmentReport Non-clinical were included in the procedure;6. criteria for the selection of experts for the evaluation of medicinalproducts have been established;7. criteria for the selection of drugs for which quality control at thestage of authorization is mandatory have been established.

Activity 2.2. Training ofM1MDA staff responsible for carrying out marketing authorisationprocedures

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At least 10 staff membersare trained on EU regulatoryaffairs and assessment ofmedicinal products held.

Activity successfully completed and the result achieved.In total, 25 MMDA employees were trained on EU regulatory affairsand assessment of medicinal products.

Participants of the training course learnt about different types ofapplications for marketing authorisation of medicinal products;requirements of the dossier (quality, non-clinical and clinical parts)of medicinal products and how to prepare the Assessment reportconsidering the type of application.

The trainers presented assessment guidelines and points onbioavailability and bioequivalence, assessment of applications forchemical medicinal products and homeopathic, biological, traditionalherbal medicinal products, assessment of SmPC, PIL and labelling,and training on assessment and management of variations. Specialrequirements for radiopharmaceuticals for ManufacturingAuthorisation were presented. Requirements for biological andchemical products were compared and biosimilar products werepresented by experts to the MMDA. Requirements for vaccines andtheir control were presented together with role of network of OMCLsfor control every batch of vaccine in are of EU.

Workshop emphasizing importance of the Pharmacopoe's role as afactor setting up the standards of quality issue for medicinal productstook place.

The assessment of generic medicinal products and unusual types ofmedicinal products, including homeopathic, traditional herbalmedicinal products, also well-established use medicinal products,radiopharmaceutical, biological and biosimilar medicines wasdiscussed. Additional discussion for clinical experts of MMDA onproblems encountered in clinical assessment of marketingauthorization dossiers took place, as well as training about the role ofQualified Person and batch release of medicinal product took place.

Activity 2.3. Development of a risk based enforcement system of medicines quality rules aswell as other GMP, GDP and GVP

• Risk-based enforcementsystem of medicinesquality rules developedand approved by theMMDA;• At least 5 Inspectorstrained.

Activity 2.3 successfully completed and the results achieved.1. Following the Recommendations of the Lithuanian expertsregarding the activity of the Inspectorate, the following StandardOperating Procedures have been developed and approved by theGeneral Director of the MMDA:1.1. Performing GDP inspections at wholesale distributors ofmedicinal products for human use; code A14.SOP-02, ed.02,approved 12.12.2018;- Issuing, modifying, suspending and withdrawing ProductionAuthorizations, GMP and GDP Certificates; code A14.SOP-06, ed.l,approved 12.12.2018;- Sampling of products, substances and materials by GMP, GDP andGPP Pharmaceutical Activity Authorization Department; codeA14.SOP-05, ed.02, approved 12.12.2018.

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1.2. Performing GVP inspections:- C02.SOP-03 - GVP inspections approved on 15.02.2019, version 01,2. 8 MMDA staff attended the trainings.

During the 1st mission of the Activity 2.3 in the field of GMP/GDPPowerPoint presentations General overview of the current status of arisk-based GMP inspections and enforcement system in the SMCA and"General overview of the current status of a risk-based GDP inspectionsand enforcement system in the SMCA" were presented and discussed.STEs shared best Lithuanian and EU practice in the field of the GMPand GDP inspections, enforcement systems.

The second mission consisted of the separate workshops for GVPand GDP, GMP. Therefore, the main work of the STEs was to traincolleagues from the MMDA on GVP inspections and to share theexperience on GVP inspections. The STEs presented generalinformation of the current status of a ris -based GVP, GDP, GMPinspections to the responsible employees of the MMDA and sharedLithuania s and Polish experience and practice and mentioned theproblems tha the Republic of Lithuania, as well as the Republic ofPoland, has faced.

The second GMP/GDP mission was aimed at the familiarization withthe current risk-based enforcement system related to GMP, GDP andGVP in the MMDA.

During the thir mission the following topics were presented anddiscussed: risk-based GVP inspection planning system; regulatoryactions and sanctions in Pharmacovigilance inspections;recommendations for • strengthenin GVP inspection activity;Recommendations to the MMDA for development of the enforcementstrategy on GMP/GDP.

In addition, the analysis of MAH requested documents before jointGVP inspection was performed and documentation for inspectionwere prepared in cooperation with MMDA experts.

Also, a first joint GVP inspection in the Republic of Moldova wasconducted. After the joint GVP inspection findings and key points forthe inspection report were discussed.

As well, traini gs on using of risk management principles duringperformance of GMP and GDP inspections, on risk based managementof Suspected Quality Defects of medicinal products and initiation andmonitoring of necessary Recalls, as well as on training on the EURapid Alert Notifications system and risk based approach in decision¬making process regarding recalls of medicinal products, suspensionand/or revocation of Marketing, Manufacturing and Wholesaledistribution authorisations were organized.

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In otal, 7 MMDA staff attended the trainings on GVP inspectionPsychology and Joint GVP inspection in the Republic of Moldova.

As a result, the Recommendations Following the Assessment for theMMDA Risk-based Draft Enforcement Strategy were developed by theSTEs and submi ted to the MMDA.

Activity 2.4. Strengthening of pharmacovigiiance by establishing a better functioningpharmacovigilance unit

Pharmacovigilance functionof the MMDA strengthenedto EU level:e The plan with goals and

milestones to strengthenPhV system prepared;

• The key elements ofSOPs fo ADR reporting,signal management,RMP, PASS and PSURassessment prepared;

At least 3 MMDAPharmacovigilance staff aretrained on thePharmacovigilancefunctions

Activity 2.4 successfully completed and the results achieved.

1. Pha macovigilance function of the MMDA strengthened to EU level:® The Plan with Goals and Milestones to strengthen PhV System

prepared;• The Key Elements of SOPs for ADR reporting, signal management,

RMP, PASS and PSUR assessment prepared.2. 9 MMDA Pharmacovigilance staff were trained on thePharmacovigilance functions.

During the first mission the following topics were presented anddiscussed: Goals of the activity, the foreseen results and workingmethods; Lifecycle of drugs: approval and post-marketingsurveillance ; "Suspected Adverse Reactions (SARs) and AdverseDrug Reactions (ADRs) causality assessment from the legal andpractical perspective"; "The experience of the SMCA in ADRreporting ; "The experience of the SMCA in Management of Lac ofEfficacy"; The questionnaire on ADR reporting, signal detection andRisk Minimisation Measures was prepared; The analysis of the legalacts/documents, as well as the answers to the questionnaireprepared by the short-term experts was performed; Other relevantquestions raised by the MMDA were discussed.Also, the Visibility item, namely, Draft Poster on ADR reportingaddressed for patient was discussed with the MMDA staff.

The second mission was aimed for familiarization of the STE withthe current situation related with the pharmacovigilance activities.The information was collected using the available legal acts,documents and interviews. Therefore, the main work of the STE wasto train colleagues from MMDA on PSURs and RMPs assessment andto share Lithuania s and Polish experience.

During the third mission the following topics were presented anddiscussed: Goals of the activity, the foreseen results and workingmethods; "Signal management ; Post authorisation safe y studies(PASS) and post authorisation efficacy s udies (PAES) ;"Additional pharmacovigiiance activities, including riskminimisation measure/programs ; The analysis of he legalacts/documents was performed; Working plan with goals andmilestones in order to improve pharmacovigilance system; Key steps

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on SOPs of signal management, PASS assessment wasprepared; Other relevant questions raised by MMDA were discussed.

The raining on Signal Management, RMinM and PASS/PAESassessment has been provided.

In total, 9 Pharmacovigilance experts were t ained on thePharmacovigilance functions.

The plan with goals and milestones to strengthen PhV system wasrepared by STEs and submitted to the MMDA. As well as, the Key

elements of SOPs for ADR reporting, signal management, RMP, PASSand PSUR assessment prepared by the STEs and presented to theMMDA.

As a result of the STEs recommendations and observations the SOPson PSUR reception, validation, evaluation and approval have beenapproved by the MMDA Director General.

Activity 2.5. Improving pharmacovigilance by reaching out to the medical and pharmaceuticalcommunity

• Criteria for inclusion tothe list of medicines foradditional monitoring isdesigned and adopted bythe MMDA (e.g. vaccines,new medicines);

• Pharmacovigilance andregulatory awareness inthe medical andpharmaceuticalcommunity raised;

• Educational modulesdeveloped and at least 4persons are trained forseparate groups (e.g. theMMDA staff, health careproviders, patientrepresentatives - ondemand) includingtraining materialprovided.

Activity 2.5 successfully completed and the results achieved.•Criteria for inclusion to the list of medicines fo additionalmonitoring designed and approved by the MMDA;•Pharmacovigilance and regulatory awareness in the medical andpharmaceutical community raised;•Educational modules developed and more than 100 persons weretrained.

Within this activity the STE analysed general information of thecurrent s atus of PhV activities in the MMDA Pharmacovigilance andClinical Trials unit. The information was collected using the availablelegal acts, documents, questionnaire and interviews.

During the second mission trainings for MMDA staff on addi ionalrisk minimization measures and additional monitoring wereorganized.As well as a training for healthcare professionals and patients ti ledAdverse Drug Reaction Reporting and Rational Use of Medicines andMedical Devices: Challenges and Best Practice was commonlyorganized by the MoHLSP, the MMDA and the EU-funded TwinningProjec . The main purpose of the Conference was to raise theawareness of adverse dru reaction reporting and rational use ofmedicines and Medical Devices. The event was attended by more than100 attendees from the BC and was speedily disseminated throughthe local and national media. All the attendees received trainingcertificates.

The third mission was aimed at the familiarization with the currentsituation related with the pharmacovigilance activities, e.g. raisingand measuring awareness levels for ADR reporting systems through

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campaigns, collaboration with patient organisations to promote andsupport patient ADR reporting, paper ADR reporting forms andhandling telephone calls from public in the Republic of Moldova.

The STE discussed with MMDA staff topics related with sources ofDrug Law and Drug precursors in European legislation.Manufacturing, reprocessing and processing of drugs and chemicalswas described, the entities authorized to obtain the necessarypermits, requirements, storage conditions, safeguards, supervision,evidence of activities and repo ting was presented and discussed.STE presented system for narcotic drugs and statistical returnssystem for narcotic drugs. Wholesale trade import and exportauthorization system was presented to the MMDA staff as wellas assessment system and statistical reporting system ofpsychotropic substances. Finally, substitution treatment wasdiscussed in particular regulations, supervision, qualification ofpatients for programs and new psychoactive substances - NFS. Themain work of the STE was to share Lithuanian and Polish experienceand practice and to mention the problems that the Republic ofLithuania, as well as the Republic of Poland, has faced.

During the fourth mission two training sessions were organized: oneon ADR Reporting, PSUR Assessment and Improvement ofKnowledge of the Latest EU Pharmacovigilance Assessments andanother on Implementation of drugs Framework into the NationalLegislation . In total, 10 MMDA experts were trained during thismission.

During the trainings, the concept of additional monitoring wasexplained and discussed. MMDA experts were trained how topromote ADR reporting by public and healthcare professionals.Additional, information how to use publicly available data related toEU pharmacovigilance assessments, practical aspects forconsideration during PSUR assessment were also provided.

The training has stren thened the abilities of the MMDA staff on howto determine legitimate requirements of narcotic drugs andpsychotropic substances, monitoring and controlling thei use,ensuring the adequate availability of controlled substances fo licitpurposes. Also, the MMDA experts were familiarized with the primeresponsibilities and main functions of National Competent Authorityfor Narcotics.

Recommendations and proposals were provided in the directoutputs: Recommendations and criteria for inclusion to the list ofmedicines for additional monitoring and in the key elements topromote ADR reporting by public and healthcare professionals. As aresult, the MMDA included additional monitoring components in theSOP.

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SOP C02.SOP-01 on monitoring adverse drugs reactions has beenapproved on 15.02.2019, version 02,SOP C02.SOP-02 on provision of information on suspected adversereactions/lack of efficiency has been approved on 15.02.2019,version 02.

As well, following the Twinning activities on awareness andpromotion of the ADR reporting, the number of adverse drug reactionreporting in Moldova increased from 277 in 2016 to 940 in 2018.

Activity 2.6. rafting SOP Clinical Trial authorisation procedure

Establishment ofprocedures in medical-ethical committee andMMDA: a SOP for theauthorization of clinicalt ials of medicinal productsat the MMDA developed andadopted by MMDA includingvalidation, evaluationp ocesses of the submitteddocuments and issuing ofadministrative decision


During the first mission the ST were familiarised with the curren legal requirements and existing MMDA internal documents in thecontext of the autho isation of the clinical trials in the MMDA.Also, STE have held round table discussions with MMDArepresentatives on practical aspects of the procedures at the MMDA(evaluation of the clinical trials applications, decision makingprocesses).

During the second mission round table discussion with the MMDAand National Ethics Committee representatives on practical aspectsof the procedures (evaluation of the clinical trials applications,decision making processes) were organized. The STEs werefamiliarised with the changes of the legal requirements for theauthorisation of clinical trials in the Republic of Moldova.

Also, workshops on the main EU requirements in respect of theauthorisation procedures of the clinical trials, on the collaborationbetween the competent authorities and the ethics committees in theRepublic of Lithuania, the Republic of Poland and the Republic ofMoldova, as well as assessment of the quality part of the CTapplication dossier and assessment of the clinical part of the CTapplication dossier were organized by the STEs. The representativesfrom the MMDA Clinical Trials Department as well as from theNational Ethics Committee were attending the workshops.

During the second part of the Mission the STEs have updated the SOPfor the Authorisation of Clinical Trial Application and the SOP for theApproval of Substantial Amendment of Clinical Trial in the Republicof Moldova. Both SOPs were analysed and agreed with therepresentatives of Clinical Trial Department and Quality Departmentof MMDA.

As a result, following the recommendations and documents draftedby the STEs, following documents were adopted by the MMDAGeneral Director:

1. C02.SOP-08 - approval of clinical studies with medicines -implementation of experts recommendations, updating the

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clinical study assessment form, approved on 15.02.2019,version 03,

2. C02. SOP-09 - approval of amendments to clinical study -implementation of experts' recommendations approved on15.02.2019, version 02,

3. C02. SOP-11 - inspection in the clinical study - implementationof experts' recommendations, updating the GCP inspectionreport forms approved on 15.02.2019, version 02,

4. C02. SOP-09 - approval of amendments to the clinical studyapproved on 15.02.2019, version 02.

Activity 2.7. Strengthening the functioning of the MMDA with respect to clinical trials

©Accessors of clinical trialapplications, includingIMPD, trained;

©Template of theassessment report of theclinical trial applicationdossier proposed.

Activit 2.7 successfully completed and the results achieved.1. In total more than 10 MMDA experts were trained on theassessment of clinical trial application dossier.2. Template of the assessment report of the clinical trial applicationdossier prepared.

During the first mission STE were familiarised with the currentassessment report template and legal requirements and proceduresfor the assessment of clinical trials dossiers in the Republic ofMoldova.STE have shared their experience in Lithuania on the assessment ofthe regulatory, clinical, non-clinical and statistical parts of the clinicaltrial application dossier.New clinical trials designs (the adaptive design clinical trials andfirst-in-human trials) were introduced and discussed with the MMDAstaff.The key elements of the proposed template of clinical trialassessment report form were draf ed.Additionally, STEs organised three workshop panels.

During the second mission, the STE organized two workshop panels.The STEs shared their experience on the requirements for theInformed consent procedures and Informed consent form, ethicalconsiderations for clinical trials on medicinal products conductedwith minors. In addition, topics on the requirements for theassessment of the substantial modifications of clinical trials,distinguish between clinical trials and non-interventional trials andrequirements for the contraception measures for the clinical trialsparticipants were covered during the training sessions.

STE together with MMDA experts have had joint assessme t followedby the round table discussion on the selected clinical trial applicationdossier.

Activity 2.8. Study visits in respect of Component 2

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o 2 MMDA experts involvedin the marketingauthorisation procedurestrained in marketingauthorisationrequirements of the EU;

o 2 GMP and 2 GDPinspectors of the MMDAtrained in GMP and GDPinspection processfollowing the EUrequirements;

« 2 GVP inspector of theMMDA trained in GVPinspection processfollowing the EUrequirements.

Activity 2.8 was successfully completed and the results achieved,o 2 MMDA experts involved in the marketing autho isation

procedures were traine in marketing authorisation requi ements

of the EU;e 2 GMP and 2 GDP inspecto s of the MMDA were trained in GMP

and GDP inspection process following the EU requirements;e 2 GVP inspector of the MMDA were trained in GVP inspection

process following the EU requirements.

The activity has been divided into three parts depending on thethematic:First part, in respect of the authorization of medicinal products, wasattended by 3 MMDA experts, whom, during the study visit werefamiliarized with the main medicines marketing authorisationprocedures applied in the European Union. The study visit wasorganized by the staff of the SMCA and took place at the premises ofthe SCMA in Vilnius and Kaunas (the Republic of Lithuania).Moldavian experts were familia ised with the marketingauthorization processes introduced in the SMCA, the databases usedin the SMCA as well as trained on the various activities related to theauthorisation of the medicinal products (p imary evaluation andvalidation of the dossiers, assessment of the quality, safety andefficacy of medicinal products, management and approval ofvariatio procedures). As well, Lithuanian experts shared theirpractical knowledge and experience on the authorisation ofmedicinal products in Lithuania.Additionally, the MMDA experts made visits to the LithuanianUniversity of the Health Sciences where MMDA delegates visitedresearch laboratories and were introduced to on-going research

projects.

The second part, in respect of the GDP, was attended by 2 MMDAexperts.During the second mission the MMDA experts were familiarised withthe EU harmonized inspection procedures, formats of Inspectionreport, GDP certificates, GDP non-compliance. ManufacturingAuthoris tion as well as national formats and procedures used in theactivity of the SMCA.Additionally, the SMCA experts o ganized an observed GDPinspection performed in conjunction with enforcement procedures inLithuania where qualified Lithuanian GDP inspectors shared theirpractical knowledge and recom endations on how to prepare aforeseen inspection, in what ways inspection can be conductedincluding plant tour, how to report observed deficiencies and how theprinciple of classification of deficiencies is compiled, what actionsshould be perform in cases of critical deficiencies and GDP non-compliances.

The third part, in respect of the GMP and GVP, was attended by 2: MMDA GMP experts and 1 MMDA GVP expert, during which the GVPexpert was familiarised with the U harmonized inspection

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procedures, formats of Inspection report, certificates, GVP non-compliance, as well as national formats and procedures used in theactivity of the SMCA. Also, the GVP expert participated in thepharmacovigilance audit and was introduced to routinepharmacovigilance activities such as adverse drug reaction, signalmanagement and the risk minimisation measures assessment

processes.Additionally, the SMCA experts organized one observed GVPinspection performed in conjunction with enforcement procedures inLithuania where qualified Lithuanian GVP inspectors shared theirpractical knowledge and recommendations on how to prepare aforeseen inspection, in what ways inspection can be conductedincluding plant tour, how to report observed deficiencies and how theprinciple of classification of deficiencies is compiled, what actionsshould be perform in cases of critical deficiencies and GVP non-compliances.

Also, the GMP experts were familiarized with the main procedures ofGMP inspection applied in the SMCA, all steps, requirements forcompetence of inspectors, traceability, documents and datamanagement, decision making criteria and other EU requirements tobe applied as well as acquisition of practical knowledge in the GMPinspection area of medicinal products.During the study visit, part of GMP, the SMCA, and manufacturing siteof the Valentis company in Vilnius were visited.

Following each part of the study visits, the findings were presentedby the participants and discussed during the Steering CommitteeMeetings. As well, participants at the study visits organizedworkshops at the MMDA, where the study visit attendeesdisseminated findings and shared the experience gained to theircolleagues.

Component 3: Strengthening of the MMDA s regulatory functioning with respect to medicaldevices.

Activity 3.1. Development of a SOP for the supervision of the medical devices market

SOPs for the supervision ofthe medical devices marketdeveloped by the MMDA incooperation with Polishexperts and approved by theMMDA

Activity 3.1 successfully completed and the results achieved.Following SOPs prepared:

• SOP for Issuing Authorization/Refusal on Starting the ClinicalInvestigation in the Republic of Moldova;

• SOP for Monitoring Incidents Investigations and Field SafetyCorrective Actions Implementation;

• SOP for Issuing Authorization/Refusal on Making theAmendments to the Clinical Investigation and for Supervisionover the Clinical Investigation in the Republic of Moldova.

During the first ission discussions about organisation of theURPLWMiPB and MMDA, present and future duties andresoonsibilities of MMDA in respect of medical devices, as well as the

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current status of the MMDA legal basis took place. The URPLWMiPBSTEs p esented the EU market of the Medical Devices (characteristicsof the MD market, key definitions elated to the MD, classification ofMD etc.). A small workshop on the classification of medical deviceshas been organised. MMDA experts were also familiarized with themain elements of SOP as well as the key requirements. TheURPLWMiPB SOPs in respect of medical devices were presented anddiscussed. The URPLWMiPB together with the MMDA starteddrafting the SOP in respect of clinical studies of medical devices.

During the second mission the processes of implementation of newregulation concerning medical devices, clinical trial documentationassessment, supervision over conducting clinical trial, as well assupervision over implementing the FSCA and action taken afterreceiving the incidents report have been discussed. The Polishexperts together with the MMDA staff worked on the drafted SOPs forthe MMDA which will be appropriate and effective.

During the third mission, the Standard Operating Procedure forissuing authorization/refusal on starting the clinical investigation inthe Republic of Moldova, the Standard Operating Procedure forMonitoring Incidents Investigations and field Safety CorrectiveActions Implementation and Standard Operating Procedure forIssuing Authorization/Refusal on Making the Amendments to theClinical Investigation and for Supervision Over the ClinicalInvestigation in the Republic of Moldova were draf ed by the STEs onthe basis of EU member states best practices.

Workshops on improving the MMDA SOP's draft concerningauthorisation/refusal for starting the clinical investigation, andconcerning the supervision over conducting clinical trial, as well as inimproving the MMDA SOP's the MMDA SOP s draft concerning thesupervision over implementing the FSCA and action taken afterreceiving the incidents report were organized.Also, the main aspects of the surveillance over the notified bo iesunder current and future legislation and market surveillance ofmedical devices under current and future legislation were presentedby the Polish experts.

On 15 Janua y 2019 the MoHLSP approved its Action Plan for 2019.According to the Objective No 6 Increasing the access of thepopulation to qualitative, safe and efficient medicines and medicaldevices , next activities in respect of the irect output of this activityare planned to be carried out:

• Drafting and approving the improved regulatory frameworkon the clinical investigations of medical devices - 3rd quarterof the 2019.

Activity 3.2. Training ofMMDA staff in respect of medical devices

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At least 8 staff members ofthe MMDA are trained onfunction as competentauthority.

Activity 3.2 successfully completed and the results achieved.10 MMDA staff members were trained on functioning as competentauthority for medical devices.

During the first mission, aspects of qualification and classificationfor the medical devices, key definitions related to the IVD medicaldevices, new evolutional rules for IVD medical devices under newRegulations, qualification and classification both fo IVDMD and MD,as well as the conformity assessment procedures including the rolesof manufacturers and Notified Body for MD and IVDMD, werepresented.

During the second mission trainings of the MMDA staff in respect ofmedical devices was organized. Also, workshops on verification ofconformity assessment documentation for medical devices and oncontrol of conformity assessment documentation of IVD medicaldevices were organized.

The results achieved during the third mission was familiarizationwith practical approach for performing inspections in the field ofmedical devices market surveillance, audits of quality managementsystems, protect the Community market form the nonconformingmedical devices and procedures concerned with authorization odNotified Bodies.

Activity 3.3. Strengthening of vigilance and strengthening enforcement

• Medical incident reportsprocessing and supervisionof field safety correctiveactions (FSCA) conducting.

• Recommendation formedical devices vigilancesystem prepared andapproved by the MMDA.


Report on the legal. framework for medical devices vigilanceincluding recommendations for improvement and the proposals onenforcement of medical devices legislation in the market have beenprepared and approved by the MMDA.

Following the STEs recommendations following measures have beenimplemented so far: the MMDA requested all healthcare institutionsto nominate the representative to be responsible for vigilanceactivities. Also, in order to make the incidents reporting moreattractive for the users, training have been organised for healthcareprofessionals, distributors, information on sent to all medicalinstitutions and Authorized Representatives. In addition, thedeadline for incident notification established in the Law on MedicalDevices (Art 16 p 1(b)) has been extended.

During the first ission he MMDA staff was introduced with therole of Competent Authority in the supervising of manufacturer smedical incident investigation and with the process of clarifying thecauses of the medical incident

As a continuation, during the second mission the MMDA staff wasacquainted what role the Competent Authority will have to meet in

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the case where the manufacturer or the authorized representative ofthe medical device will undertake the Field Safety Corrective Actions(FSCA) in order to minimize the risk of death or serious deteriorationin state of health associated with medical device placed on themarket. On the example of Polish Act on Medical Devices andAppropriate Decrees, the MMDA staff gained practical knowledgeabout important tools for strengthening of vigilance andstrengthening enforcement as well.Summarizing the main goal achieved after the second mission wasthe familiarization the MMDA staff with majority of aspects of themedical incident reporting process and the supervision of FSCAconducting according to current directives: Directive 90/385/EEC of20 June 1990 relating to active implantable medical devices, Directive93/42/EEC of 14 June 1993 concerning medical devices, Directive98/79/EC of 27 October 1998 on in vitro diagnostic medical devices,as well as MEDDEV 2.12/1 rev.8 guidance.

Furthermore, the MMDA staff was familiarized with the crucialprinciples in assessment of the clinical investigation dossier and withthe role of such entities as the sponsor, investigator, EthicsCommittee and Competent Authority in the field of clinicalinvestigations on medical devices.

During the third mission, a summary of the MMDA experts obtainedknowledge was made. Also, discussions on problems concerningoperation of the Vigilance System in a prope way were held.By the end of the mission, workshops on the assessment of thedocumentation of clinical investigations were organized. Also, themost important tools for strengthening of vigilance andstrengthening enforcement were emphasized. Moreover, theforthcoming approach given by new Regulations was presented onthe example of the provisions ofRegulation (EU) 2017/745.

During the fourth mission, all the aspects that should be changed inthe Moldavian Law concerning Medical devices as well as in theempowerments and entitlements of the MMDA in the matter ofactivities related to the clinical investigations of medical devices suchas issuing decisions in this matter based on the assessment of clinicalinvestigations documentation were discussed.

On 15 January 2019 the MoHLSP approved its Action Plan for 2019.According to the Objective No 6 Increasing the access of thepopulation to qualitative, safe and efficient medicines and medicaldevices , next activities in respect of the direct output of this activityare planned to be carried out:

Drafting and approving the improved regulatory frameworkon the registration of the medical devices not bearing CEmarking - 3rd quarter of the 2019;Drafting and approving the improved regulatory frameworkon the PhV system of medical devices 3rd quarter of the 2019;

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Activity 3.4. Design of IT infrastructure for medical devices register

Recommendations for thedatabase for themanagement andmaintenance of medicaldevices, includingrecommendations fornotification and datagathering proceduresprepared

Activit 3.4 successfully completed and the results achieve .Recommendations for the database for the management andmaintenance of medical devices, including recommendations fornotification and data gathering procedures has been prepared

During this activity, trainings in respect of medical devices wereorganized by the STE. During the trainings, the 6 MMDA expertsgained a better understanding of New European Regulations in thescope of registration of medical devices and European Databank onMedical Devices - Eudamed according to new regulations, as well asa better understanding of the current and future regulatoryframework, i.e. Directives: 90/385/EEC, 98/79/EC, 93/42/EEC andnew Regulations regarding medical devices (2017/745) and in vitrodiagnostic medical devices (2017/746) and differences betweenthem.

Also, presentation of the Polish medical device database anddocumentation gathering by the Office for Registration of MedicinalProducts, Medical Devices and Biocidal Products (ORMPMDBP) and,information about medical devices, entities responsible form placingmedical devices on the market and certificates were presented.

Activity 3.5. Study visits in respect of components

• Familiarization MMDAemployees with casesdocumentation.Presentation of specificproblems which occurduring data gathering,supervision over medicaldevices and sharingexperience.

• 3 MMDA staff memberstrained in best practices inregulation of medicaldevices.


• MMDA employees were familiarised with cases documentation.Specific problems which occur during data gathering, supervisionover medical devices as well as sharing experience were provided,

• 3 MMDA staff members trained in best practices in regulation ofmedical devices.

The main purpose of the study visit within the Activity 3.5 was tocomplete the training of the MMDA s medical devices department,organized within the Activity 3.2 in respec of the organisation oftheir duties.

During the study visit, the 3 Moldavian experts had the possibility toread over the particular cases documentation e.g. reports andnotifications, manufacturer inspection, supervision investigation,clinical trial application. They were able to get to know the vigilancedata base, Eudamed, Central Clinical Trials Database, medical devicesdatabase and participate in daily work of the Department of MedicalDevices Surveillance, Vigilance and Clinical Trials and Departmentfor Information on Medical Devices.

Additionally, the URPLWMiPB experts presented specific problemswhich occur durin data atherin , supervision over medical devices

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and solutions adopted by the URPLWMiPB. The study visit includedt ainings at the URPLWMiPB and at the Notified Body PolskieCentrum Badah i Certyfikacji.

Following each part of the study visits, the findings we e presentedby the participants and discussed during the Steering CommitteeMeetings. As well, participants at the study visits organizedworkshops at the MMDA, where the study visit attendeesdisseminated findings and shared the experience gained to theircolleagues.

Component 4: Improvement of rational use of medicines and medical devices

4,1 Expert mission about improving mechanisms to ensure availability and access

• A report on thepossibilities to improvemechanisms to ensureavailability and accessprepared and approvedby the MMDA;

® The plan in respect of thecentralised procurementsystem and pricing andreimbursement decisiontaking prepared andapproved by the MMDA.

Activity .1 successfully completed and the results achieved.During the first mission of the STE, several meetings and discussionsessions with the MMDA Bu eau of Prices, the Cen ralizedProcurement Centre for Health ofthe Republic of Moldova, the CNAM,the representative ofthe Health Ministry of the Republic of Moldovahave been o ganized.

The best practice of Lithuania regarding pricing and reimbursementof the medicinal products was shared. The STEs also familiarized withthe general principles ofthe pricing, purchasing and reimbursementprocedures that are applied in the Republic of Moldova. The analysisof the structure of Moldovan medicinal products pricing andreimbursement sector was made.

During the second S.TE ission a workshop in respect of thereimbursement of the medicinal products as well as medical deviceshas been held at the Ministry of Health, Labour and Social Protectionof the Republic of Moldova. During the workshop Lithuanian STEpresented the following topics: legal acts of the Republic of Lithuaniaregulating reimbursement of medical products and medical devices;criteria ofthe inclusion into reimbursement system and monitoringof expenditures; cost containment measures, including managedentry agreements and negotiations. The workshop was attended byrepresentatives of the MMDA, CNAM, MoHLSP and State University ofMedicines and Pharmacology Nicolae Testemi eanu .

The input provided by the STEs shall contribute to the establishmentof a sound base to facilitate further efforts of the CNAM, the MoHLSPand the MMDA to develop and maintain an appropriate and effectivereimbursement, pricing and central procurement system inaccordance with the best practices ofthe EU countries.

As a result of this activity a Report on the possibilities to improvemechanisms to ensure availability and access, including the Plan inrespect of the centralised procurement system and pricing and

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reimbursement decision taking was prepared and delivered to theMMDA, MoHLSP and CNAM which has been endorsed by the BC.

On 15 January 2019 the MoHLSP approved its Action Plan for 2019.Acco ding to the Objective No 6 Increasing the access of thepopulation to qualitative, safe and efficient medicines and medicaldevices , next activities in respect of the di ect output of this activityare planned to be carried out:

Revising the mechanism of placing on the market of medicaldevices not bearing CE marking in the 4th quarter of the 2019;Revising the mechanism of including the reimbursedmedicinal products, essential medicinal products, of selectingcentrally procured medicinal products for the needs ofhospitals and the medicinal products for the national healthprograms by merging them into a single process in the 4thquarter of the 2019;Revising the list of reimbursed medicinal products in the 4thquarter of the 2019;Revising the mechanism on the control over the prices for themedicinal products which a e marketed and placed on theinternal market in the 2nd quarter of the 2019.

Activity 4.2. Strengthening of Compliance / Training of GMP, GDP and GCP inspectors

At least 4 inspectors trained(GMP, GDP and GCP]

Recommendations onenforcement of complianceand action plan forenforceme t developed andaccepted by the MMDA.

Activity 4.2 successfully completed and the results achieved.8 MMDA experts were trained on GMP and GDP qualification andvalidation,4 MMDA experts were trained on strengthening of GCP inspectoratewith regards to future participation in EMA.Recommendations on enforcement of compliance and action plan forenforcement developed and accepted by the MMDA

The first mission (Part GCP] consisted of presentations and practicalworkshops dedicated to sponsor/CRO inspection conducted mainlyin the EU mainly in the context of centralized procedure. Real lifesimulation of the sponsor inspection was arranged. The aim of thiswas also to analyse the current status of GCP inspection system in theRepublic of Moldova. The STEs used the questionnaires and interviewmethod. The information gathered during this activity was used forrecommendations given by STEs.

The first mission (Part GMP/GDP] consisted of the theoreticaltraining of the MMDA GMP/GDP inspectors on current EU GMPrequirements (Volume 4] and their changes and Compilation ofprocedures as well as inspection of HVAC and validation activitiesduring GMP/GDP inspections. The first mission of GMP/GDP part wasaimed to discuss the compliance of the MMDA SOPs with theCompilation of procedures.

The second mission, part of GMP and GDP, consisted of observationof the MMDA GMP/GDP inspectors preparation fo the outine GMPinspection, adherence to actual MMDA relevant procedure including

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development of the GMP inspection plan for specific type of GMPinspection on the manufacturing site. The theoretical discussion oncurrent EU GMP inspection conducting and related procedures basedon Compilation of Community Procedures on Inspections andExchange of Information took place as a standard for GMP inspectionactivities.

During the third mission of the GMP and GDP part, the review of therelevant MMDA SOPs and their comparison with Compilationprocedures was made. MMDA SOPs inadequacy was indicates andwith the MMDA inspectors was discussed. Insufficient regulation ofwholesale distribution activity by the legal acts of the Republic ofMoldova were pointed out and discussed.

The procedural steps of the GDP inspection process were discussedbefore inspection and during the inspection itself were observed. Thefindings, observations and conclusions were discussed with theinspectors.

The second mission, part of GCP consisted of presentations anddiscussions in regard of the GCP inspection. The goal was to focus onthe EU requirements of current and new legislation on GCPinspection in the light of centralized procedure.

Additionally, during the mission was presented the Polish experiencein preparation of annual inspection plan taking into account the riskcriteria and Polish activities connected with breaches of GCPrequirement as well as the polish process of choosing andpreparation the GCP inspectors to their chores in national inspectionbut also in EU GCP inspection.

The aim of the mission was also connected with the review the MMDASOP to give recommendation in regard the new EU Regulation. ThePolish database of GCP inspection was presented to potential use byMMDA.

The third mission of the GCP part consisted of conducting GCPinspection in the Republic of Moldova, analysis of the inspectionresults as well and practical and theoretical training. Inspection inone of Moldavian site was arranged. For two days STEs advised andresolved queries arising during the inspection.Apart from the practical actions of the STEs prepared presentationswith practical training dedicated to inspection report template andGCP requirements for advanced therapy medicinal products.The last topic covered was reporting of GCP inspection in an EMAformat for different types of inspections, including preparation if theIntegrated Inspection Report.

Activity 4.3. Enforcement of legislation about promotion of medical products

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« Analysis of Moldovanlegislation on advertisingof medicinal productsand control proceduresincludingrecommendations andaction plan forimprovement prepared;

® Overview of advertisinginfringements identified;enforcement measures;

® 2 relevant inspectors aretrained.

Activity 4.2 successfully completed and the results achieved.1. Analysis of Moldovan legislation on advertising of medicinalproducts and control procedures including recommendations andaction plan for improvement prepared;2. Overview of advertising infringements identified conductedenforcement measures presented and explained;3. 6 BC experts were trained on evaluation of the advertisement ofMedicinal Product as well as case studies of specific infringements.

The first and the second mission were successfully completed, MMDAstaff trained, overview of the advertising infringements provided,final report prepared.

During the first mission review of the legislative framework in theRepublic of Moldova on advertising of medicinal products wasperformed, provisions on advertising of medicinal products includedinto the Draft of Medicinal products law of the Republic of Moldovawere analysed and discussed, regulatory experience of the Republicof Lithuania on advertising of medicinal products andimplementation of legal requirements were presented; practical casestudies on advertising of medicinal products were organised.

During the second mission the most common infringements relatedto advertisement (promotion) of medicinal products, how to conducta monitoring of advertisement, self-regulation principles andpotential system for inspection and enforcement in respect ofadvertising (promotion) of medicinal products, as well aspreparation of system for inspection and enforcement in respect ofadvertising (promotion) of medicinal products were analysed duringthe meetings.Lithuanian experts shared their experience and provided answers tothe questions raised by participants.

A Report on the Analysis of Moldovan legislation on advertising ofmedicinal products and control procedures includingrecommendations and action plan for improvement was prepared bythe STEs and delivered to the MMDA. Following the STEsrecommendations, C02.SOP-12 - procedure for the evaluation of theadvertising material was adopted by the Director General of theMMDA on 15.02.2019, version 01.

Activity 4.4. Development communication strategy rational use

• Strategy document aboutrational usecommunication prepared;

• Conference withstakeholders held;


• Strategy document about rational use communication prepa ed;• Conference with stakeholders held. More than 100 attended the

event;• The plan for rational drug use improvement prepared.

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* The plan for rational druguse improvementprepared and approved.

The mission was aimed at the familiarization of the STE the existingsystems of rational use of medicines in the beneficiary country. TheSTE used the document analysis and interview methods. Theinformation was collected using the available legal acts, documentsand interviews. Experience sharing sessions and conference werealso organized. The STE also consulted with the relevant experts andofficials from the MMDA, as well as the other relevant bodies engagedin the analysed processes.

Additionally, the STEs were involved in caring out the ConferenceAdverse Drug Reaction Reporting and Rational Use of Medicines andMedical Devices: Challenges and Best Practice. The event wascommonly organized by the EU-funded Twinning Project team, theMMDA and the MoHLSP. The main purpose of the Conference was toraise the awareness of adverse drug reaction reporting and rationaluse of medicines and Medical Devices. The event was attended by theMinister of Health, Labour and Social Protection of the Republic ofMoldova, the General State Secretary of the MoHLSP, the GeneralDirector of the MMDA, the RTA, representatives of the healthcareinstitutions and rep esentatives of the public associations and otherstakeholders. In total, more than 100 attended the event. Informationabout the event was speedily disseminated through the local andnational media. All the attendees received training certificates.

As a result of the mission, an educational plan for distribution ofdecisions issued by the competitive authorities and rational use of MPand medical devices plan for the Republic of Moldova was prepared.

On 15 January 2019, following the proposal of the STEs, the MoHLSPapproved its Action Plan for 2019. According to the Objective No 6"Increasing the access of the population to qualitative, safe and efficientmedicines and medical devices", next activities are planned to becarried out:

Submission of the Draft Law of medicines to the Governmentin the 4th quarter of the 2019;Revising the mechanism of placing on the market of medicaldevices not bearing CE marking in the 4th quarter of the 2019;Revising the mechanism of including the reimbursedmedicinal products, essential medicinal products, of selectingcentrally procured medicinal products for the needs ofhospitals and the medicinal products for the national healthprograms by merging them into a single process in the 4thquarter of the 2019;Revising the list of reimbursed medicinal products in the 4thquarter of the 2019;Revising the mechanism on the control over the p ices for themedicinal products which are marketed and placed on theinternal market in the 2nd quarter of the 2019;

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Revising the mechanism on the periodic verification ofmedical devices put into service and being used 4th quarter ofthe 2019;Initiating the process of training the uses of medical devices inacco dance with the provisions of art.15 of the Law no.102 onmedical devices as subsequently amended and in compliancewith the provisions of the joint Order of Ministry of Health,Labour and Social protection and Ministry of Education,Culture and Research 920/1165 as of 27 July 2018 2nd quarterof the 2019.

Activity 4,5. Strengthening of supervision of pharmacies and enforcement of GPP

Training on supervision ofpharmacies andenfo cement of GPP withthe recommendations forimprovement of legalframework for GPPinspectors conducted.

Activity 4.5 successfully completed and the results achieved.1. 13 GPP inspectors from the MMDA and NAPH, as well as expertsfrom the MoHLSP, CNAM, State Medicines University and Associationof Pharmacists of the Republic of Moldova were trained onsupervision of pharmacies and enforcement of GPP;2. The Report together with the Recommendations on Strengtheningof Supervision of Pharmacies and Enforcement of GPP prepa ed.

The first mission aimed at the training of the staff of the MMDA, theMoHLSP, the NAPH and representatives of the pharmacy associationsin the field of regulation of pharmacy activities in Lithuania, includinglicensing of applicants and supervision of holders of licenses,recognition of pharmacy specialists and familiarization with legalframework regarding pharmacy and pharmacy specialists' activitiesand supervision of pharmacies.

Information about Lithuanian and othe MSs pharmaceutical sectorregarding pharmacy practice and supervision was presente .

In addition, the STEs analysed the existing systems in the Republic ofMoldova. The STEs used the document analysis, slides and interviewmethods. The information was collected using the available legal ac s,documents and interviews.

During the second mission trainings on Pharmacy activity in theRepublic o Moldova and the Republic of Lithuania, Actions followingthe inspections. Enforcement actions in the SMCA and the MMDA,Rules of Licencing in the Republic of Moldova and the Republic ofLithuania were carried out.

in addition, the STEs along with representatives of the NAPHorganized common GPP inspection at the University'sPharmaceutical Center Vasile Procopisin in the Republic ofMoldova.

Activity 4.6. Study visit related to component 4

2 GMP inspectors and 2GDP inspectors trained inGMP and GDP inspection

Activity .6 successfully complete and the results achieved.1. 2 GMP inspectors and 2 GDP inspectors we e trained in GMP andGDP inspection process following the EU requirements;

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process following the EUrequirements;2 GCP inspector trained inGCP inspection processfollowing the EUrequirements;2 GPP inspectors trained inGPP inspection processfollowing the nationallegislation requirements.

2. 2 GCP inspectors were trained in GCP inspection processfollowing the EU requirements;3. 2 GPP inspectors trained in GPP inspection process following thenational legislation requirements.

The Activity was divided into three parts depending on the thematic.During first mission held in the Republic of Poland, (part of GCP),the Moldavian experts were familiarised with the U harmonizedinspection procedures, formats of inspection report, certifica es, GCPnon-compliance, as well as national formats and procedures used inthe activity of the URPLWMiPB. Also, the Moldavian expertsparticipated in the clinical trial documentation assessment and evenidentified several findings.

Additionally, the URPLWMiPB experts organized one planned GCPinspection performed in conjunction with enforcement procedures inPoland where qualified polish GCP inspectors shared their practicalknowledge and recommendations.

During the second mission, held in the Republic of Lithuania, theGMP/GDP inspectors from he SMCA organized two joint inspections(one GMP and one GDP). The SMCA experts info med the MMDAinspectors about the EU harmonized inspection procedures, formatsof inspection report, GMP/GDP certificates, GMP/GDP non-compliance, as well as national formats and procedures used in theactivity of the SMCA.

During the third mission organized in the Republic of Lithuania, theGPP experts from the MMDA and the National Agency on PublicHealthcare were familiarized with the GPP inspection processfollowing the EU requirements for conducting and reporting of GPPinspections, applying of necessary and appropriate administrationmeasures.

Following each part of the study visits, the findings were presentedby the participants and discussed during the Steering CommitteeMeetings. As well, participants of the study visits organizedworkshops at the MMDA, where the study visit attendeesdisseminated findings and shared the experience gained to theircolleagues.

Component 5; Transition of the MMDA to full compliance with the EU requirementsActivity 5.1, Strengthening assessment capacity

Assessment capacitystrengthened:• The MMDA experts and

assessors familiarisedwith the structure andwork of the EMA;

• At least 3 MMDA expertstrained on preparation of

Activity 5.1 successfully completed and the results achieved.21 MMDA experts and assessors were familiarised with the structureand work of EMA as well as trained on the preparation of theassessment report based on EMA guidelines and templates.The role of expert committees, expert's groups and national expertsand the EMA staffs was introduced. Assessments of medicines atdifferent points of their lifecycle, as well as the scientific guidelinesand assessment s templates prepared by the EMA were explained.

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assessment report on thebasis of the EMAguidelines and templates.

The MMDA experts and assessors were t ained to prepa e anassessment report based on the EMA guidelines and templates.

Best practice and recommendations of the SMCA and theURPLWMiPB have been shared.

The training was focused on the assessment of pharmaceutical,preclinical, and clinical dossiers. Additional discussion on problemsencountered in the clinical assessment of marketing authorizationdossiers took place.

Activity 5.2. Development of Good Governance Practice

9 The criteria applied in theBEMA benchmarkingsystem of the EUmedicines regulatoryagencies presented to theMMDA;

® The current systemevaluated and ananalytical report on GoodGovernance provided.

Activity 5.2 successfully completed and the results achieved.1. The criteria applied in the BEMA benchmarking system of theEU medicines regulatory agencies presented to the MMDA;2. The current system evaluated and an analytical report on GoodGovernance provided.

The first mission consisted of presentations and practicaldiscussions dedicated to Benchmarking of European MedicinesAgencies (BEMA).

The STEs form Lithuania presented key aspects of qualitymanagement in regulatory authorities. The STEs from Polanddiscussed the BEMA questionnaire in the light of assessment plannedat the MMDA during the second mission of this activity. Ratingcriteria were explained for every KPI discussed during the workshop.

During the econd mission the self- ssessment based on BEMAquestionnaire 09, which escribes KPIs was discussed. The MMDA wasrequested to support its self-assessment with evidence of the activitiescarried out under individual KPIs. The applicable rating system aimedat the assessment of the maturity and good overnance of the Agency'spolicies, systems and regulatory activities was presented and explained.

During the mission the experts carried out the interviews with theMMDA staff members in charge of each KPI, when necessa y asked foradditional clarifications and requested the presentation of evidence inthe form of documents (manuals, SOPs, website publications, internalorders, registe s, etc.).

As a result, the BEMA self-assessment followed by the auditsimulation conducted by the p ofessional BEMA auditors showedthat the MMDA is well governed and appropriately prepared in termsof scientific and regulatory knowledge to carry out activities as EUNational Competent Authority for medicinal products. Althoughactivities in the area of medical devices are not covered by the BEMAassessment it was stated that the good governance of the MMDA alsoapplies to medical devices.

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The main outcome of the activity showed, that: the qualitymanagement system is well developed and continuously monitoreda the MMDA. All activities are covered by internal audits and CAPAsystem is in place. Relevan ISO standa ds a e adhered to. Wellestablished rocedures are followed across the Agency. Recentchanges of competence and structure of the Agency show sufficientflexibility and efficacy of managerial processes in the agency. GXPinspection system was mentioned as a strong element oforganization.

Development and implementation of electronic tracking system inthe area of authorization of medicinal products was also regarded asa strong point of the Agency. It is important to mention that therewere no discrepancies between the ratings of individual KPIsproposed by the BEMA team and the Agency staff members.

There were areas that need furthe improvements, e.g. crisismanagement or general timelines compliance monitoring. Someexamples of opportunities for improvement were presented by theSTEs. A full package of recommendations was provided in the finalreport.

Activity 5.3. Developing new tasks for the Qualit Control laboratory

® Assistance to the MMDAexperts inpreparing/updating thenational legislation,quality managementsystem documents andother relevantdocuments for gettingstatus of the OfficialMedical ControlLaboratory certified bythe EDQM provided;

• The recommendationsand action plan for thereorganisation/repositioning of thePharmaceutical QualityControl laboratoryapproved by the MMDA.

Activity 5.3 successfully completed and the results achieved.STE provided assistance to the MMDA experts in preparing/up atingthe national legislation, quality management system documents andother relevant documents for getting status of the Official MedicalControl Laboratory certified by the EDQM as well as providedrecommendations and action plan for the Quality Control Laboratory.As a result, on July 9, 2018 the Quality Control Laboratory ofMedicines was attested by the European Di ectorate for the Qualityof Medicines and Healthcare, which declared that the Laboratory hassatisfactorily implemented a Quality Management System inaccordance with ISO/IEC 17025, with the relevant texts of theEuropean Pharmacopeia, with the Quality Management Guidelinesand the Terms of Reference od the General European OMCL Network.The attestation is valid until January 2022. With the successfulcompletion of the MJA 13/17, the Quality Control Laboratory ofMedicines was confirmed as a full member of the General EuropeanOMLC Netwo k (GEON).

During the first mission STE from the SMCA intro uced MMDA staffwith the activities of the Medicines Control Laborato y of the SMCAand shared its experience as the member of GEON. Series of themeetings and discussions were held in respect of the Activity 5.3.Taking into account the EDQM Terms reference requirements for thefunctioning of the Quality Control Laboratory also taking into theconsideration the current legal acts related to the functioning of theLaboratory (its activities, functions, place in the system,responsibilities and etc.) as well as taking into account the foreseen

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Mutual Joint Audit in 10 - 12 October 2017, the recommendationswere p epared and provided to the MMDA.Those recommendations inter alia refer to the declaration of p ivateinterests of the Laboratory staff, measures to exclude the conflicts ofinterests as well as recommendations to fully implement thestandard ISO 17025:2005 „General requirements for the competenceof testing and calibration laboratories" as well as the EDQM termsreference and guidelines requirements, revision of the managementsystem procedure for the management of samples which are thesubject of the state quality control of medicines and etc.

During the second mission (12/03/2017-18/03/2017), the STEfrom the SMCA introduced MMDA staff with the risk assessment forthe selection of medicinal products for marketing surveillancetesting. The Laboratory staff was introduced with the EDQMdocument "Risk Based Model for Targeting Medicinal Products forMarketing Surveillance Testing PA/PH/OMCL (07) 87 7R, EDQMGeneral procedure for Sampling and Testing of Centrally AuthorisedProducts, PA/PH/CAP (05) 49 10R STE from the SMCA shared theexperience on how to apply the testing scheme focusing on post¬marketing su veillance of medicinal products including risk analysismodel for market surveillance testing and presented the currentscheme in the SMCA.Discussion with the Head of Laboratory as well as the staff who willperform the risk assessment in the MMDA, possible risk factors forevaluating medicinal products for market surveillance testing, whowill coordinate the preparation of the sampling and testing plan,forms of records were held.Additionally, assistance to the MMDA staff for the preparation of theDraft management procedure for the risk assessment for selection ofmedicinal products for marketing surveillance testing was provided.STE from SMCA also helped the MMDA to prepare for the EDQMMutual Joint Audit (MJA) which will be held in 10 - 12 October 2017.In this respect, the Laboratory management procedures Managementof Documents, Control of Records, Assuring the Quality of Test wererevised, the Recommendations according to standard ISO 17025,EDQM guideline Management of Documents and Records,PA/PH/OMCL (14) 19 6R were provided. The STE from the SMCA alsoassisted the MMDA in preparation of some relevant forms of recordswhich we e not in place at the MMDA.As the Laboratory did not have SOP for test methods applied in theLaboratory (according to standard ISO 17025 point 5.4.), the ossiblecontent of such SOP was discussed.Additionally, one-day training for the Quality Control Laboratorystaff with the aim of getting the MMDA familiarised with theLaboratory activities acc. to the EDQM terms of reference, activitiesof the Medicines Control Laboratory of the SMCA as well as theimplementation of the EDQM quality management guides, riskassessment for targeting medicinal products for marketingsurveillance testing, Official control authority Batch release forvaccines and blood products and various test methods.

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During the third mission (2017-07-31 - 2017-08-04) consultationsin respect of management of reference substances, reagents,equipment, volumetric glassware, samples and environmentalconditions, management of personnel, test methods and methodsvalidation, evaluation and reporting test results were held.STBs organised round table discussions in regards of the handlingand use of reference substances, reagents, calibration andverification of equipment and laboratory volumetric glassware,handling, protection, identification, traceability and storage ofsamples, monitoring of environmental conditions, pharmacopoeial(compendial) methods, manufacturing methods of a manufacturer,transfer of test methods, test methods validation, trainings ofpersonnel, investigation of out of specification results, content of testreports.

Various Quality Control laboratory management procedures, for e.g.,Management of samples, reference substances, volumetricglasswa e, and equipment, validation of test methods, personnel,evaluation and report test results were revised and evaluated.STBs from SMCA also p ovided considerable assistance to the MMDAin preparation for the EDQM Mutual Joint Audit (MJA) scheduled on10 - 12 October, 2017 and preparation of the Draft test methodprocedures.Suggestions and guidance were given for filling the EDQM checklistAide memoire for MJA/MJV of OMCL.

Also, an additional half-day training in respect of Liquidchromatography (HPLC) test method and evaluation of resultsaccording to EDQM guideline Evaluation and Reporting of ResultsPA/PH/OMCL (13) 113 2R was provided to the QCL staff.

During the fourth mission the staff of Quality Control Laboratory ofthe MMDA was assisted by the STE in the process of implementationof some corrective actions approved b the EDQM Mutual Joint Auditauditors.The STEs shared experience on the practical implementation of thecalibration, verification, qualification of Laboratory equipmentaccording to international standard 13017025:2005, EuropeanPharmacopoeia (hereinafter - Ph.Eur.) and EDQM guidesrequirements. Discussion on the evaluation of calibration andqualification results of Laboratory equipment and measurementinstruments and their compliance with acceptance criteria were held.Performance the practical exercises with Laboratory personnelresponsible for management of Laboratory equipment andmeasurement instruments was organized. Also, the STEs review ofthe Laboratory standard operation procedure A01.SOP-04Laboratory Equipment, edition 4 and identification of inconsistenciesand inaccuracies in the standard operation procedure A01.SOP-04.

As a result of this activity, taking into consideration therecommendations of the STEs, following documents were officiallyapproved by the BC institutions:

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I. Activity of Quality Control Laboratory of MMDAThe Order of the Minister of Health of the Republic of Moldova onquality control of medicines has been approved (Order no. 887 of11.07.2018 regarding the modification and completion of the Orderof the Ministry of Health no. 521 from 01.06.2012);

II. Conflict of interest« On 13.08.2018 the Regulation regarding the Institutional

Integrity Insurance has been approved;® The Quality policy of MMDA has been revised on 07.02.2018.® The Quality Manual (QM) A01.MC was updated on

03.02.2017.« The Order No. 521 from 01.06.2012 of the Minister of Health

of the Republic of Moldova on quality control of medicineshas been amended. Order no, 887 of 11,07.2018 regardingthe modification and completion of the Order of the Ministryof Health no. 521 from 01.06.2012 pt. 2);

« The Draft Procedure based on risk approach for selection ofmedicinal products has been drafted.

III. Quality management system® The Quality policy of MMDA has been revised on 07.02.2018.

The Quality Manual (QM) A01.MC was updated on03.02.2017.

® Quality management procedures A01.SOP-17 Analysis ofrequests, tenders and contracts, edition 02 from 19.03.2018and AOl.SOP-22 Subcontracting Tests, edition 02 from19.03.2018;

® The Laboratory Regulation was updated on 16.06.2017. Alljob descriptions of Laboratory personnel were updated inJuly 2018,

® the Matrix of responsibilities A05.PG-01.F01 has beenupdated.

* the Order on appointing of responsible person forimplementation and monitoring of Laboratory ManagementSystem has been approved.

® Organisational chart of the Quality Control Laboratory of theMMDA, edition 01 from 11.04.17; QMS Organizational Charted. 01 from 11.04.17;

® Quality management procedure A10.SOP-03 Competence,awareness, training, edition 01 from 27,09.2017 (common);Following have been developed: List of QCL authorisedpersonnel A10.SOP-03.F16, Lis of authorized personnel onadministrative tasks and substitutes; List of AuthorizedPersonnel for physico-chemical and microbiologicallaboratory analyses; List of Authorized Personnel forupdating QCL MS procedures; List of authorized personnelon the management of laboratory equipment and measuringinstruments.

The following procedures were updated and approved takinginto account EDQM guidelines and ISO 1702 5

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e Quality management procedure A06.SOP-12 Control ofproducts and services provided from outside, edition 03 from06.07.2018 (common);

e Quality management procedure A01.SOP-03 Accommodationand environmental conditions, edition 05 from 12.04.2018;

® Quality management procedure A01.SOP-02 Servicesprovided by QCL, edition 02 from 26.03.2018;Quality management procedure A01.SOP-04 Laboratoryequipment has been revised on 01.03.2018, edition 04;Quality management procedure A01.SOP-05 Cleaninglaboratory glassware edition 04 from 01.02.2018;Quality management procedure A01.SOP-06 Evaluation andReporting of Results, edition 05 from 19.03.2018;Quality management procedure A01.SOP-08 ReferenceStandard, edition 05 from 30.04.2018;

0 Quality management procedure A01.SOP-09 Reagents andvolumetric solutions, edition 08 from 04.05.2018;

® Quality management procedure A01.SOP-10 Sampling ofMedicinal Products for State Quality Control, edition 07 from02.02.2018;

o Quality management procedure A01.SOP-12 Registration andvalidation of computer systems, edition 01 from 05.03.2018;Quality management procedure A01.SOP-16 Water used inlaboratory, edition 03 from 19.03.2018;

« Quality management procedure A01.SOP-07 Quality Controlin the Authorization Procedure for Medicines edition 01 from04.12.2018;

0 Quality management procedure AOl.SOP-13 Meeting QCLedition 02 from 02.02.2018;

® Quality management procedure A01.SOP-14 Registration anddistribution of MP in QCL, edition 03 from 02.02.2018;

• Quality management procedure A01.SOP-20 HPLC columns,edition 03 from 19.03.2018;

• Quality management procedure AOl.SOP-23 Columns CGL,edition 03 from 19.03.2018;

• Quality management procedure AOl.SOP-26 Determinationof visible particles, edition 02 from 19.03.2018;

• Quality management procedure AOl.SOP-29 Services toclient, edition 03 from 07.03.2018;

• List of external documents was amended and reviewedA05.PG-01:F03 from 18.06.18

Test Methods. The requirements of EDQM and Ph.Eur. have beenincluded in the test method procedure.

• Test method procedure A01.TMFC-05 IR FTIR Method,edition 01 from 07.09.17;

• Test method procedure A01.TMFC-02 Optical RotationMethod, edition 01 from 25.08.17;

0 New test method procedure A01.TMFC-04 HPLC Method,edition 1 from 18.09.2017;

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® New test method p ocedure A01.TMFC-07 GC Method,edition 1 from 19.10.2017;

© New test method procedure A01.TMFC-16 Capilla yelectrophoresis, edition 1 from 31.05.2018.

Activity 5.4. Management of the medical products market during the transition

©Analysis of the structureof the pharmaceuticalsector and supply systemprepared;

® statistical data ofpharmaceutical marketanalysed, the shortages ofthe main relevantmedicinal products and itsreasons identified;

® Recommendations forimprovement oflegislation and action planprepared and approved bythe MMDA.

Activity 5.4 successfully completed and the results achieved.©Analysis of the structure of the pharmaceutical sector and supply

system prepared;© statistical data of pharmaceutical market analysed, the shortages of

the main relevant medicinal products and its reasons identified;© Report with Recommendations and Action Plan for improvement oflegal framework and management of the medicinal productsmarket during the t ansitional period of the Republic of Moldovawas p epared and p esen ed to the BC institutions.

During the first mission the foreseen changes in the legislation of theRepublic of Moldova regarding transition that may have an impact onthe Register of Medicinal Products of the Republic of Moldova, supplychain and access to medicinal products were analysed.Also, meetings with representatives of the MoHLS, the MMDA, theCNAM and the CPCH were organized.As well, meetings with the representatives of the MMDA responsiblefor Marketing Authorization, for GMP/GDP Inspections, staff of theLaborato y for the Medicines Quality Control, and Impo t/ExportAuthorisation Unit were organized.

During the second mission the analysis of the foreseen changes inthe legislation of the Republic of Moldova related to transposition ofEU acquis that may have an impact on the Register, the supply chainan access to medicinal products during the transition perio wascontinued.The main aspects were discussed on options to ensure accessibilityof medicinal products during transition period.Representatives of the MMDA responsible for authorization ofmedicinal products, import, supervision, representatives of theNational Agency on Public Healthcare esponsible for procurement ofvaccines and cont ol of pharmacies took part in the meetings anddiscussions.During the mission the STEs we e p ovided with information aboutthe reimbursed medicinal products in the Republic of Moldova,internet links to reimbursed medicinal products, information for thepublic, information for pharmacies and wholesale distributers, anddata from the Register of medicinal products in excel.

On 15 January 2019 the MoHLSP approved its Action Plan for 2019.Accor ing to the Objective No 6 Increasing the access of thepopulation to qualitative, safe and efficient medicines and medicaldevices", several measures are planned for 2019 related to thisActivity, i.e., submission of the Draft Law on Medicines to the

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Government (by 4th quarter of the 2019); revision of the mechanismof including the reimbu sed medicinal products, essential medicinalproducts, of selecting centrally procured medicinal products for theneeds of hospitals and the medicinal products for the national healthprograms (by 4th quarter of he 2019); revision of the list ofreimbursed medicinal products (4th quarter of the 2019); revision ofthe mechanism on the control over the p ices for the medicinalproducts which are marketed and placed on the internal market (by2nd quarter of the 2019).

Activity 5.5. Study visit related to Component 5

4 MMDA assessors areintroduced with the EMAstructure of committees andworking parties:

2 MMDA expertsacquainted with theexperience of Lithuaniandelegates contributing tothe relevant EMA WorkingGroups.

2 MMDA expertsacquainted with theexperience of Polishdelegates contributing tothe relevant EMA WorkingGroups.

The Activity 5.5 was successfully completed and the resultsachieved.4 MMDA assessors were introduced with the EMA structure ofcommittees and working parties:- 2 MMDA experts acquainted with the experience of Lithuaniandelegates contributing to the relevant EMA Working Groups.- 2 MMDA experts acquainted with the experience of Polish delegatescontributing to the relevant EMA Wo king Groups.

During the visit to Poland, the MMDA experts we e introduced withthe structure and scope of the main EMA committees and workingparties in respect of the central authorisation of medicinal products.

The PhV Inspectors Working Party, the European Union InnovationNetwork, the Co-ordination Group for Mutual Recognition andDecentralized Procedures, the scientific committee Herbal MedicinalProducts Committee, the Substance Product OrganisationReferential, the scientific committee for Advanced Therapies, thescientific committee for Human Medicinal. Productsand Scientific Advice Working Party were presented by the Polishexperts to the MMDA staff.

Basic information on different procedures and practices of the EMAand its committees in safeguarding patient health, in Europe werepresented. The main attention was focused on the introduction to theprocedures for centrally authorised medicinal products.

During the visit to Lithuania, the main attention was focused on theintroduction to the pharmacovigilance and the main issues related toit.

The main purpose of the study visit to the Lithuania wasfamiliarization with EU legislative procedures, the experience of theLithuanian experts in their work at EMA, being members of theworking groups of the European Commission and Council of the EU(work particularities, expertise knowledge and other relevantexperiences).

Following each part of the study visits, the findings were presentedby the participants and discussed during the Steerin Committee

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Meetings. As well, participants a the study visi s organizedworksho s a the MMDA, where the study visit attendeesdisseminated findings and shared the experience gained to theircolleagues.

2E-IMPACT

(a) Specify to what extent the achievement of the results led to the achievement of the purpose of theproject and the overall objective (measured against the benchmark(s) specified in the Work Plan).

(b) List any unexpected results of the project.

Mandatory results and benchmarks (as inLog frame)

Achievement

Overall Objective: Full and correct implementation of the EU acquis in the area of medicinalproducts and medical devices and preparation of the Medicinal products and the Medical DevicesAgency („MMDA ) for joining the EU regulatory a encies network as an equal partne .

Benchmarks (copied from the Log Frame)Alignment with EU Acquis and implementationof best practices of EU

The main purpose of the alignment with EUacquis was following:

1. Review and evaluation of the approximationof the legal framework on medicinal products,clinical trials and medical devices of the Republicof Moldova.2. Review and evaluation of the approximationof the Draft Law on Medicines of the Republic ofMoldova as of 04/2017, 12/2017, 02/2018 tothe EU acquis.3; Preparation of Recommendations for theimprovement of legislation of the Republic ofMoldova on medicinal products, clinical trialsand medical devices.

In carrying out the above-mentioned tasks, theexisting relevant legal framework of theRepublic of Moldo a has been reviewed. Theanalysis performed covered key legal actsrelated to the medicinal products, clinical trialsand medical devices. In total, more than 27binding legal acts (primary and secondary) havebeen e aluated against EU acquis.

In order to contribute to the establishment oflegal requirements on medicinal products theconsiderable amount of time was devoted to theanalysis of the consecutive versions of the DraftLaw on Medicines with the view of compliancewith Directive 2001/83/EC, identification oflegal gaps or inconsistency with the EU acquis.

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The sharing of experience of Lithuania ontransposition of Di ective 2001/83/EC into thenational legislation was provided as an exampleof the p oper legal approach.

The performed analysis and assessments of thelegal framework of the Republic of Moldova aswell as of the Draft Law on Medicines resul ed inelaboration of recommendations forimprovement of the relevant legal framework ofthe Republic of Moldova with the objective ofthe accomplishment of the full approximation tothe EU pharmaceutical legislation.As well, work undertaken provided BC with abetter understanding of the EU acquis onmedicines and medical devices and the way ithas to be applied in practice.

Next step - adoption of the Draft Law onMedicines aligned with the EU acquis in theParliament.

Project Purpose: Strengthening of the functioning of the MMDA with regards to clinical trials,marketing autho isation, manufacturing and distribution authorisation, vigilance, centralprocurement, pricing, reimbursement and distribution of medicinal products and medicaldevices, authorisation of pharmaceutical activity as well as supervision and reinforcement.Benchmarks (copied from the Log Frame)

Analytical reports and recommendations forbringing legislation and functioning of theMMDA in line with EU acquis and practice.

SOPs established for main regulatory functions.

Well-trained MMDA officials.

Policy in respect of rational use of medicinesdeveloped.

Preparation of the MMDA for transition to fullcompliance with the EU requirements.

26 months of intensive agenda in respect ofmedicines, medical devices and pharmaceuticalactivity resulted in strengthened institutionaland organisational capacities of the BCinstitutions (especially MMDA which is the mainbeneficiary of the Twinning Project).

Analytical reports and recommendations forbringing legislation and functioning of theMMDA in line with EU acquis and practice havebeen prepared. Those covered for e.g., BCinstitution activities and responsibilities inrespect of the clinical trials, marketingauthorisation, manufacturing and distributionauthorisation, pharmacovigilance, advertising,pricing and distribution of medicines andmedical devices, supervision and reinforcement(GCP, GMP, GDP, GPP, GVP inspections) as wellas rational use of medicines and medical devicesand quality mana ement system applied in theMMDA.SOPs have been established for main regulatoryfunctions (for e.g., in context of clinical trials,marketing authorisation, pharmacovigilance,GMP/GDP).

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Following the STEs recommendationssecondary legislation as well as internal acts ofthe MMDA have been adopted/updatedaccordingly. For e.g., in respect of thefunctioning of the Quality Control Laboratory ofMedicines more than 30 documents have beenu dated/drafted and officially approved by BCinstitutions following the STEsrecommendations.The capacity of the BC staff has beensignificantly improved through trainings,workshops, conferences and working meetingswhere experienced EU officials shared theirknowledge and best EU practice in the contextof medicinal products and medical devices. Oneof the biggest achievements - The EDQM issuedattestation fo the Quality Control Laboratory ofMedicines. In total, more than 900 attendeesattended Twinning activities. Most successfulevent - Conference-training on ADR reportingand Rational Use of Medicines and MedicalDevices attended by more than 100 healthcareprofessionals and regulators.

Preparation of the MMDA for transition to fullcompliance with the EU requirements has beenevaluated through BEMA tool whereexperienced BEMA auditors concluded that theMMDA is well governed and appropriatelyprepared in terms of scientific and regulatoryknowledge to carry out activities as NationalCompetent Authority for medicines.

2 F - FQLLOW-IIP AND USTAINABILI Y

(a) In what way will the results of the project / recommendations be utilised by the BC administration?(b) How is the BC administration going to continue with the work started under the project?(c) In case of failure to achieve the mandatory results in their entiret , what future actions should thefinal BC administratio take i order to achieve them?

During the duration of the Twinning Project the main Beneficiary (MMDA) together with other BCinstitutions involved has benefited from the exceptional assistance and the support provided by theTwinning partners from Lithuania and Poland. This Twinning Project was the most valuable projectwithin the health system in the Republic of Moldova allowing for the alignment of the Moldavian legalframework to the standards of the Eu opean Union and strengthening the capacities of CompetentAuthority for the medicinal products and medical devices. The MMDA and the MoHLSP confi medtheir strong commitment to collaborate so that the Draft Law on Medicines, aligned to the EU acquis,

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is accepted within the Government in 2019 and adopted by the Parliament of the Republic ofMoldova.

The Twining tool allowed sharing the best practices of Lithuanian and Polish competent authoritiesfo medicines and medical devices as well as sharing theoretical and practical examples andexperience in the areas of medicines and medical devices (for e.g., the clinical trials, marketingauthorisation, manufacturing and distribution authorisation, pharmacovigilance, advertising, pricingand distribution of medicines and medical devices, supervision and reinforcement (GCP, GMP, GDP,GPP, GVP inspections) as well as rational use of medicines and medical devices).

The MMDA together with the MoHLSP assured Twinning partners that they will further promote theadoption of the Draft Law on Medicines aligned to EU acquis. Also, following the recommendationsof the EU-funded Twinning, the MoHLSP approved its Action Plan for 2019.

The knowledge and experience gained during the Project activities are actively used in the daily workof the MMDA. STEs from Lithuania and Poland kindly shared their contact details so that BC staffcould contact STEs in case further sup ort is needed. As well, the MMDA, SMCA and the URPLWMiPBwill continue existing collaboration on the ground of the Memorandums of Understanding signed in2017.

2 -CONCLUSIONS

Overall Assessment

Make a one-paragraph evaluation of the project, its progress and impact.

The overall evaluation of the Project is very positive. The objectives and the mandatory results areconsidered as fulfilled. The outcomes exceeded by far the expectations of the Project because not onlythe mandatory results were achieved but ties of good co-operation among Moldavian, Lithuanian and• Polish agencies have been established as well, memorandums of understanding have been signedallowing for the future coope ation, exchange of experience, information and experts' visits in thearea of medicinal products and medical devices.

Certainly, in between the launch and end of the Project there were some challenging moments,mainly arising from the heavy agenda and insti utional changes at the BC, however, efficient planningand implementation of the Twinning activities, active involvement of the Twinning managementcontributed to the achievement of the positive results.

Starting from March 17, 2017 the per diem rate for the Republic of Moldova has been reduced from171 EUR per night to 139 EUR, therefore, it allowed to finance several additional STEs missionstaking into account the needs of the BC. Therefore, a significant number of BC staff, healthcareprofessionals and other stakeholders were able to benefit from the Twinning activities. In total, morethan 900 attendees attended Twinning events.

Project also allowed for the considerable support for the MMDA regulatory functioning as asubstantial amount of analytical reports, recommendations, action plans as well as SOPs have beenelaborated by the STEs which resulted in a substantial change of the MMDA internal acts as well aschanges to the Moldavian legislation. For e.g., only in terms of the functioning of the Quality ControlLaboratory of Medicines of the MMDA, more than 30 documents have been adopted/updatedfollowing the recommendations of the S Es.

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Due to policy changes in Moldova (mainly related to the elections to the Parliament in 2019), it wasdecided by the BC institutions to delay the submission of the Draft Law on Medicines to theParliament.

2H - RECOMMENDATIONS: lessons learnedRecommendations for future actions necessary to be undertaken in the area the twinning operates in.

The sustainability of the achieved Twinning esults mainly depends on the future steps to be followedin the area of medicines and medical devices:

- efforts to ensure that the Draft Law on Medicines, aligned to the EU acquis, is accepted withinthe Government and adopted by the Parliament of the Republic of Moldova;

- efforts to ensure that the secondary legislation is in line with the approved Draft Law onMedicines;

- efforts to ensure that the MoHLSP Action Plan for 2019 is implemented and the STBsrecommendations in the context of pricing, reimbursement and central procurement ofmedicines and medical devices are respected;

- efforts to ensure continuous close collaboration among the BC responsible institutions (i.e.MM DA, MoHLSP, CNAM, NAPH and CPCH);

- BC institutions continues strengthening its competences and capacities for exercising thefunctions as a competent authority for medicines and medical devices;

- future collaboration among the MMDA, the SCMA and the URPLWMiPB based on theMemorandums of Understanding signed in 2017;

- efforts to seek for other Twinning projects or other instruments in order to strengthen the BCinstitutions capacities in the areas that were not included in this Twinning project, e.g. controlof narcotic drugs or areas where there is additional need for further developments, for e.g.pricing, reimbursement, central procurement.

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Total amount paid Final report 40.537, 01 38.242, 44 2.294,5 7

Amount paid in Euros

Qtr 9 5.295,25

Hini O'O'

299,74

COb©¦ 4.700,89

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a 4.639,44

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Qtr 3 4.654,1 2 4.390,6 8 263,44

£ 4.608,54 4.347,68 260,86

Qtr 1 2.567,6 8 2.422,3 4 145,34

Budget after side letters/ addend a1.720, 12 39.358, 54 2.361,5 8

Original budget

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Travel costs forRTA

Per diems for RTA. PROJECT SUB¬ TOTAL PROVISIONS FOR CHANGES IN PRICES (at maximum of 2.5% of sub¬ total-) Surpl s status fsavingsl PROJECT TOTAL BC co¬ financing TOTAL CTR CRIS 2016/379970

For the administration of the Member State

Name and title of the individual(s) authorised to sign:

Mr. Gintautas Barcys, MS Project Leader, Director of the State Medicines Control Agency underthe Ministry of Health of the Republic of Lithuania

For the administration of the BC

Name and title of the individua s) authorised to sign:

Mr. Dumitru Saghin, BC Project Leade , Vice General Director of the Medicines and MedicalDevices Agency of the Republic of Moldova

CTR CRIS 2016/379970

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