Italian Regulatory 22 Affairs News · Di Renzo Regulatory Affairs - headquarters: Via dell’Arco...

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223rd June, 2019

Italian Regulatory Affairs News

Di Renzo® Regulatory Affairsheadquarters: Via dell’Arco di Travertino 1100178 - Romeregistered office: Viale Manzoni 5900185 - RomeTel. +39 06 / 77 20 90 20 +39 06 / 89 68 35 18 Fax. 06 / 70 45 00 [email protected]

Italian Regulatory Affairs NewsN. 22 - 3rd May, 2019

WEEKLY MAGAZINE

Editor in Chief:Sante Di Renzo

Subeditor:Maria Pia Felici

Layout:Maurizio Isopo

Italian Regulatory Affairs News 3

Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma Tel. + 39 06 / 77 20 90 20 - +39 06 / 89 68 35 18 - Fax. 06 / 70 45 00 99 - www.direnzo.biz - [email protected]

Italian Regulatory Updates

AIFA clarifies MA transfer submissionThe Italian Medicine Agency has clarified the method of submission of the applications of MA transfers of medicinal products authorised with national or mutual recognition/decentralised procedure. The application shall be submitted by the acquiring party on headed paper with revenue stamp of 16 euros, specifying the name of the product; the MA (six digits); pack sizes; MRP/DCP procedure number (if applicable); full name, address, telephone and fax number and e-mail address and SIS code of the ceding company; number of the procedure and/or of the type I C.I.8 variation regarding the change of the pharmacovigilance system and the relevant date of submission (if applicable); number of the procedure and/or of the type I A.2 b) variation regarding the change of the name of the product and the relevant date of submission (if applicable); request of time extension for the marketing of batches already manufactured but not released with not updated PIL and labelling; indication and details of the company contact point for the managing of the procedure, with transmission of any proxy, in case of outsources consultants of the concerned companies. If the pharmacovigilance system, the pharmacovigilance QP and the PMSF location are not changing (i.e. when the old and new holder belongs to the same group of companies), the application shall include a declaration on this regard. Moreover, the following should be included; original or true copy of the legal deed of the transfer reporting the title, name, role/qualification of the signers (ceding and acquiring party) in the company with notorised signatures (registered at the Income Revenue Authority for national procedures) with a sworn translation in case of texts in foreign languages other than English; POL receipt demonstrating the payments; the so called “Circolare n. 9/1997” on CD-ROM (for national products); copy of the product information amended with changes required by the transfer in clean and tracked version in electronic format in three separate files (SmPC, PIL and labelling) for all



authorised pack sizes; request of time extension for the marketing of batches already manufactured but not released with not updated PIL and labelling;The latter shall be submitted concomitantly with the transfer application, and in any case not beyond the date of implementation and shall include the name of the product; the name or the European procedure (if applicable); the six-digit MA number; the date of beginning and end of the batch manufacturing; the serial identification number of the batches for which the time extension is requested; the original or true copy of the agreement for the public deed or with notarised signature between the new and old MA holder regarding the time extension.



Independent research studies publishedThe Italian Medicine Agency made available for health professionals the studies carried out with the independent research funds assigned from 2005 to 2012. The Agency stressed once more their focus on the research aimed at stimulating areas of scarce interest for profit companies. In the meantime the funds provided for by the research call 2018 of the Ministry of Health have been assigned: about 93 million euros to be shared by more than 200 projects of innovative biomedical research with a duration of 3 years. The funded areas include rare diseases; metabolic diseases (diabetes, inflammatory, immunologic and muscoloskeletal diseases); neurological diseases, neuropsychiatric, neurodegenerative diseases (Parkinson, Alzheimer, multiple sclerosis etc.). Several projects are dedicated to the search of biological biomarkers for diseases where prevention and early diagnosis are essential (oncological and cardiovascular diseases). Almost half of the projects were submitted by young researchers.



Levocarb shortage monitoredThe Italian Medicine Agency is continuing its monitoring of the availability of the medicinal product containing carbidopa/levodopa (levocarb). The MA holder has communicated that full availability of the drug will be shortly reinstated and at the moment no pack size is under shortage. However, there could be gaps in the supply of some pack sizes. The Agency has blocked all exports of the product and has adopted any measure required to ensure the availability of the medicine. AIFA has finally reminded the importance of a responsible approach when purchasing the drug in order to avoid any stockpile.



Curcuma-containing food supplements recalledFollowing the reporting of 15 cases of non contagious and non infective acute cholestatic hepatitis by the Italian Higher Health Institute, the Italian Ministry of Health has recalled 16 food supplements containing curcuma whose use is associated to these cases.Checks are being carried out by health authorities on the whole territory and the Ministry has invited consumers to discontinue the use of these products, while waiting for the outcomes of the controls. This is not the first food supplement recalled since the beginning of this year: in 2019 a food supplement containing ginkgo biloba was recalled because of hydrocarbons exceeding the limit, a sport supplements containing forbidden stimulants and an infusion. Most of the recalls are due to the presence of bacteria and viruses, for irregularities in the composition or for traces of allergens not stated in the labelling.



Italian Court of Appeal stops light cannabisThe Italian Court of Appeal issued a long-awaited ruling on the sale of products containing the so called “light cannabis”. The Court overturned the ruling issued last February, stating that the sale of derivatives of Cannabis Sativa L. (including leaves, inflorescences, oil and resins) is a crime.The Court of Appeal has adopted a stricter interpretation of the Law 242/2016 concerning the manufacturing and marketing of cannabis light for foods, cosmetics, textiles and buildings. On the other hand, this law expressly forbids personal recreation use and bans the importations of species not listed in the European catalogue. Light cannabis is depotentiated: its content of tetrahydrocannabinol (THC, a narcotic active substance) is below 0.2%; it contains cannabidiol (CBD), whose effects include relax. The law grants a margin of tolerance of 0.6% of THC, within which farmers have no responsibilities. This new interpretation of the law will most likely lead to the closure of 1,500 companies specialised in manufacturing and sale of products containing cannabidiol.



International Regulatory Updates

IMDRF strategies on personalised devicesThe International Medical device Regulatory Forum (IMDRF) proposed to stop the use of exemptions for custom-made medical devices adopted in some countries. In particular, IMDRF stressed the technological progress in this field, allowing to make the devices as individual, but also the ways through which such personalised devices are exempted from the compliance with some regulations. This is a questionable use increasing the number of patients receiving devices with high risk classification without the required guarantees. IMDRF therefore proposed a harmonisation in the application of the existing regulatory norms based on the type of custom-made device, clarifying the requirements for each category. The document intends to be a best practice model in the harmonisation of the regulations on personalised devices at international level. On the other hand, in order to understand the applicability of these devices, the document clarifies that adaptable devices are also mass-produced and that raw materials for additive manufacturing are note regulated as devices.



WHO resolution on price transparency weakenedThe World Health Organisation adopted a resolution to push members to publicly share net prices of health products and clinical trials costs. The resolution was adopted after weeks of discussions and has also invited UNO members to facilitate the circulation of information on patents and approvals of these products and to improve nationally for an open and cooperative research, especially in developing and low- and middle-income countries.The resolution also considered the availability of clinical trial data and price information for the creation of online database to share this information in order to improve market transparency, including investments, incentives and subsidies. The resolution, proposed by Andorra, Brazil, Egypt, Eswatini, Greece, India, Kenya, Luxembourg, Malaysia, Malta, Russia, Serbia, Slovenia, South Africa, Sri Lanka e Uganda, has also obtained support from Switzerland, Portugal, Spain, Italy, Sweden, Norway, Australia and Canada. On the other hand, economically strong countries opposed it – including Germany, Japan, United Kingdom and Unites States. These were criticised for placing the interests of big corporations before people’s interests. Opposing countries has in fact asked and obtained a weakened version of the resolution, that – according to critics – lacks of effective norms and strong actions on transparency.



The European CommitteesCommittee for Medicinal Products for Human Use (CHMP)Last meeting: 27-29 May 2019Next meeting: 24-27 June 2019

The Committee for Advanced Therapies (CAT)Last meeting: 22-24 May 2019Next meeting: 19-21 June 2019

Paediatric Committee (PDCO)Last meeting: 27-29 May 2019Next meeting: 25-28 June 2019

The Committee for Orphan Medicinal Products (COMP)Last meeting: 21-23 May 2019Next meeting: 18-20 June 2019

The Committee for Risk Assessment in Pharmacovigilance (PRAC)Last meeting: 13-16 May 2019Next meeting: 11-14 June 2019

Committee for herbal Medicines (HMPC)Last meeting: 14-16 January 2019Next meeting: NA

Committee for Medicinal Products for Veterinary Use (CVMP)Last meeting: 21-23 May 2019Next meeting: 18-20 June 2019

Committee on Biocides (BPC)Last meeting: 25 February - 1 March 2019Next meeting: 24-28 June 2019



International Meetings10-13 June 2019LondonWorking Through Veterinary Drug Development in the EU and USAwww.management-forum.co.uk

12 June 2019LondonAdvanced Drafting Techniques for Successful EPO Patent Applicationswww.management-forum.co.uk

12-13 June 2019LondonManaging Lifecycle and Variations Effectivelywww.topra.org

The Italian CommissionsOpen-AIFA:Next meeting: 14 June 2019

AIFA Board of DirectorsLast meeting: 20 September 2018Next meeting: 11 June 2019

Technical Scientific Advisory CommissionLast meeting: 8-10 May 2019Next meeting: 5-7 June 2019

The Committee for prices and reimbursementLast meeting: 21-23 May 2019Next meeting: 17-19 June 2019

The Technical Health Committee-AdvertisementLast meeting: 28 May 2019Next meeting: 19 June 2019

Veterinary CommissionLast meeting: 28-29 May 2019Next meeting: NA

New headquarters for Di Renzo Regulatory Affairs

Two thousand square meters on four floors, and almost 100 employees.

This is the new face of Di Renzo Regulatory Affairs.

After more than 30 years spent in our historical headquarters of Viale Manzoni, as of 6th May 2019 the Company has moved to the headquarters in Via dell’Arco di Travertino 11, in Rome, to gain more space for our increasing international and dynamic vocation.

The new headquarters are free-standing, modern, sunny and surrounded by greenery, and perfectly embody the values of quality, organisation, dynamism and internationalisation that Di Renzo Regulatory Affairs has been carrying forward as its own project since its foundation.

The new headquarters bind the architectonic and functional aspect – taking care of the staff well-being – with the standards of efficiency and quality of our consultancy services.

The vocation of the company is that of further widening the relationship with institutions and international companies of the pharmaceutical and regulatory sector, always ensuring more and more extended competence to Italian clients as well.

In fact, we believe that new challenges represent a dynamic incentive to perfect our how-to-be and widen our know-how. Because knowledge is a process and not just information.

Italian Regulatory 22 Affairs News · Di Renzo Regulatory Affairs - headquarters: Via dell’Arco...

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