EDQMOverview of our

products and services

www.edqm.eu www.edqm.eu/store

2017

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Guide to the Quality and Safety of

Organs for Transplantation

EDQM6th Edition

2016

EUROPEAN PHARMACOPOEIA

European Pharmacopoeia 2017 UPDATE (9.3-9.5) The earliest access to the European quality standards

Description:■ Applicable in 38 European countries and used in over 100 worldwide.

■ Continuously updated, with new and revised texts published three times a year.

■ Delivers crucial information earlier than any other Pharmacopoeia.

■ NEW format just released for 9.3: downloadable version with direct access to the Knowledge database.

■ Available in both online and print formats; QR codes for direct access to the Knowledge database.

■ A number of packages are available.

■ Unlimited licences and discounts applicable for multiple licences. Do not hesitate to contact the EDQM for a quotation.

■ Includes free access to the online archive.

For more information visit the EDQM Storewww.edqm.eu/store

■ CombiStats™: statistical analysis software computer program for calculations in accordance with chapter 5.3 of the European Pharmacopoeia.Product details:https://go.edqm.eu/combistats

Pharmeuropa Online: the Ph. Eur. free forum Help us to shape the future Pharmacopoeia

Description:■ Ph. Eur. texts for comment: published continuously, with 4 deadlines for comments per year.■ Pharmeuropa Bio & Scientific Notes: news in the biological standardisation area and scientific articles linked to the work of the Ph. Eur.■ Pharmeuropa archives: free access to 30 years of electronic archives.Product details:https://go.edqm.eu/pharmeuropa

Other products of interest:

■ Online Knowledge Database for information on a substance or text in the Ph. Eur.: https://go.edqm.eu/knowledge■ Technical Guides and the Ph. Eur. Style Guide are available here: https://go.edqm.eu/techguides

Standard terms database Free resource to be used in Marketing Authorisation dossiers

Description:■ Contains standard terms for pharmaceutical dose forms, routes and methods of administration, containers, closures, delivery devices, combined terms and patient-friendly terms for medicines for human and veterinary use.■ European Union Guideline status: must be used in marketing authorisation applications for medicines (i.e. the Application Form and the Summary of Product Characteristics (SmPC)).■ 952 individual terms and over 25 000 translations in 33 languages.

Product details:https://go.edqm.eu/standardterms

Commission Sessions

Edition/ Supplement

Publication schedule

Corrections to be taken into

account as soon as possible and

not later than

Implementation dateSession No. Date

153 November 2015 9th Edition July 2016 31 August 2016 1 January 2017

154 March 2016 9.1 October 2016 30 November 2016 1 April 2017

155 June 2016 9.2 January 2017 28 February 2017 1 July 2017

156 November 2016 9.3 July 2017 31 August 2017 1 January 2018

157 March 2017 9.4 October 2017 30 November 2017 1 April 2018

158 June 2017 9.5 January 2018 28 February 2018 1 July 2018

159 November 2017 9.6 July 2018 31 August 2018 1 January 2019

160 March 2018 9.7 October 2018 30 November 2018 1 April 2019

161 June 2018 9.8 January 2019 28 February 2019 1 July 2019

162 November 2018 10th Edition July 2019 31 August 2019 1 January 2020

REFERENCE STANDARDS

European Pharmacopoeia Reference Standards (RS) Discover the 84 new RSs established in 2016

Description:■ Over 2700 RS items available: chemical, herbal and biological reference standards and materials and reference spectra.

■ Necessary for the application of Ph. Eur. monographs.

■ Carefully established and monitored by the EDQM laboratory.

■ Online RS Catalogue updated daily: RS searchable by code, name, monograph number or CAS number to quickly locate the standard you need. Contains RS Batch Validity Statement (BVS) enabling users to verify, at time of use, the validity of batches supplied. Contains downloadable Safety data sheets (SDS) and leaflets (where applicable).

Product details: http://crs.edqm.eu/

Who International Standards for Antibiotics (ISA) and Who International Chemical Reference Substances (ICRS)

Description:■ ISA: reference substances for use as primary standards in microbiological testing of antibiotics. ISA can also be used by regional or national pharmacopoeias to establish secondary standards. ■ ICRS: primary chemical reference substances. They are supplied for use in physical and chemical tests and assays described in the International Pharmacopoeia or other WHO quality assurance documents.

Practical information: ■ The EDQM distributes WHO ISA and WHO ICRS. ■ Online Catalogues updated daily: RS searchable by code, name or CAS number to quickly locate the standard you need.■ Safety data sheets (SDS), leaflets and study reports (only for ISA) available online (PDF format):

https://go.edqm.eu/ISAenhttps://go.edqm.eu/ICRSen

CERTIFICATION OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA (CEP)

Certificates of Suitability to the Ph. Eur. monographs (CEP) Make a difference to your business

Description:■ For active substances or excipients covered by a monograph in the Ph. Eur., including herbal products; any product with TSE risk.

■ Centralised evaluation of quality dossiers. ■ Replace the detailed data in quality parts of marketing authorisation applications (MAA) and facilitate the management of MAA.■ Recognised throughout all 38 Ph. Eur. member states and beyond.

■ Complemented by a risk-based inspection programme of manufacturing sites.

Practical information:For more information on the Certification procedure: https://go.edqm.eu/CEPhttps://go.edqm.eu/cepdatabase

THE HEALTHCARE COLLECTION

■ The EDQM regularly produces publications related to HealthCare activities including:

■ Blood Transfusion & Organ, Tissues and Cells Transplantation

■ Cosmetics & Food Contact Materials

■ Pharmaceutical Care

Combatting Counterfeit Medicines

Product details: EDQM Publications are available in a variety of formats, printed, downloadable or e-publications.

FREE EDQM publications can be downloaded quickly and easily from this new publications management tool:

www.edqm.eu/freepub

See our latest online catalogue above or visit the EDQM Store

OTHER PRODUCTS AND SERVICES OF INTEREST

■ Proficiency testing studies (PTS) are carried out on basic methods of analysis in the biological and physico-chemical fields within the framework of ISO/IEC 17025. https://go.edqm.eu/PTS

■ Blood Proficiency testing studies (B-PTS) are also organised to determine the performance of blood transfusion screening laboratories responsible for testing individual blood donations. https://go.edqm.eu/BPTS

■ Events, training sessions, webinars and conferences are organised all year round. A unique opportunity to interact directly with the EDQM, experts and key speakers from around the world. https://go.edqm.eu/events

Human tissues and cells are being used in an increasing variety of ways, and advances in transplantation therapy have unquestionable benefits. Human cells and tissues for human application can save lives or restore essential functions, but the use of human tissues and cells also raises questions of safety and quality. Only tissues and cells recovered, processed and stored following strict quality and safety standards are likely to function satisfactorily. Careful evaluation of donors is essential to minimise the risk of transmission of diseases. Furthermore, since human tissues and cells can currently only be derived from the body of a person, strong ethical principles need to be associated with their donation and use.

The Council of Europe approaches the donation and human application of human tissues and cells in compliance with the principles of non-commercialisation and voluntary donation of materials of human origin. This 2nd Edition of the Guide to the quality and safety of tissues and cells for human application contains information and guidance for all professionals involved in identifying potential donors, transplant co-ordinators managing the process of donation after death, bone marrow and cord blood collection centres, tissue establishments processing and storing tissues and cells (including assisted reproductive technology centres), inspectors auditing any of these establishments and organisations responsible for human application.

For matters dealing with the use of organs and blood or blood products, see the Council of Europe Guide to the quality and safety of organs for transplantation and Guide to the preparation, use and quality assurance of blood components, respectively.

Guide to the quality and safety of tissues and cells for human application

2nd Edition

Guide to the quality and safety of TISSUES

AND CELLSfor human application

EDQM

9 789287 181268

ISBN 978-92-871-8126-8

www.edqm.eu/storeISBN 978-92-871-8126-8 € 30

European Committee (Partial Agreement)

on Organ Transplantation (CD-P-TO )

EDQM2nd Edition2015

The Council of Europe is the continent’s leading human rights organisation. It comprises 47 member states, 28 of which are members of the European Union. The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect public health.

www.edqm.eu

ENG

Guide to the quality and safety of

ORGANS FOR TRANSPLANTATION

Guide to the quality and safety of organs for transplantation6

th EditionEDQM

European Committee (Partial Agreement)

on Organ Transplantation (CD-P-TO )

EDQM

6th Edition

2016

The EDQM is a Directorate of the Council of Europe – an international organisation founded in 1949, now with 47 member states covering virtually the entire continent of Europe. The Council of Europe seeks to develop common democratic and legal principles based on the European Convention on Human Rights and other reference texts on the protection of individuals.

www.edqm.eu

Pharmaceutical CarePol ic ies and Prac t ices for a Safer, More Responsible and Cost-effective

Health System

PHARMACEUTICAL CARE Policies and Practices for a Safer, More Responsible and Cost-effective Health System

Medication is the most frequent intervention within healthcare systems. Often, the benefits of medication cannot be realised in patients, and even worse, considerable mortality and morbidity are caused by the inappropriate use of medicines. Pharmaceutical care is a quality philosophy and working method for professionals within the medication process, indispensable for the good and safe use of medicines. The Committee of Experts on Quality and Safety Standards for Pharmaceutical Practices and Pharmaceutical Care, coordinated by the EDQM, carries out activities comprising the development of generally applicable and specific indicators of the implementation of pharmaceutical care in Europe and beyond. Governments and policy-makers are invited to act against harm, reduced life quality, workforce reductions, and wasted resources that arise from the inappropriate use of medicines and drug-related problems.

2012

Metals and alloys used in food contact materials and articles

A practical guide for manufacturers and regulators

Metals and alloys used in food contact materials and articles

Committee of Experts on Packaging Materials for Food and Pharmaceutical Products P-SC-EMB

The EDQM is a directorate of the Council of Europe, an international organisation founded in 1949 that covers almost the entire continent of Europe. The Council of Europe aims to develop common democratic and legal principles based on the European Convention on Human Rights and other reference texts on the protection of individuals.

1st Ed

itionED

QM

Committee of Experts on Packaging

Materials for Food and Pharmaceutical

Products P-SC-EMB

€ 30

www.edqm.euwww.edqm.eu/store

1st Edition2013European Directorate for the

Quality of Medicines & HealthCare

9 789287 177032

ISBN 978-92-871-7703-2

Metals an

d allo

ys used

in fo

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d articles

PREMS29613

2016

GUIDANCE ON ESSENTIAL OILS

in cosmetic products

Consumer Health Protection Committee (CD-P-SC)

IMPORTANT INFORMATION FOR USERS

All EDQM publications are hologram-labelled and bear a unique Publication ID (EPID code). Use your EPID code to register your publication, check its authenticity or have access to our support team (HelpDesk) go to: www.edqm.eu/register/

The EPID code is sent by e-mail when you purchase the USB stick or any of the online versions of the European Pharmacopoeia.

1 Colourful areas

2 Mirrored mini-text

3 Colourful letters and stars

4 Lens effect

ORDERING EDQM PUBLICATIONS

Prices and availability to be found under each product item on:www.edqm.eu/store

ORDERING REFERENCE STANDARDS

Catalogues:

http://crs.edqm.euhttps://go.edqm.eu/isadb https://go.edqm.eu/icrsdb

Order forms:

– CRS: https://go.edqm.eu/RSorder– ISA: https://go.edqm.eu/ISAorder– ICRS: https://go.edqm.eu/ICRSorders

SALES ORDER CONTACTS

► E-mail: orders@edqm.eu with the order forms as an attachment

► Helpdesk Publications: https://go.edqm.eu/HDpubs ► Helpdesk Reference substances: https://go.edqm.eu/HDrs

Tel.: +33(0)3 88 41 30 30 Press 2*

Payments can be made by bank transfer or credit card via the EDQM Store: www.edqm.eu/store

HOW TO KEEP UP TO DATE?

Visit our website: www.edqm.eu

Register today for our free E-Newsletter at: https://go.edqm.eu/Newsletter

Follow us on Twitter:www.twitter.com/edqm_news

Free user support service: Frequently Asked Questions (FAQ) and HelpDesk.

Please check the FAQ section to see if your question has already been answered: www.edqm.eu/hd

Postal address:European Directorate for the Quality of Medicines & HealthCare (EDQM) 7 allée Kastner, CS 30026,F-67081 Strasbourg France

* Omit the 0 if calling from outside France.

The Council of Europe is the continent’s leading human rights organisation. It comprises 47 member states, 28 of which are members of the European Union. The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect public health.

Direction européennede la qualité du médicament& soins de santé

European Directoratefor the Quality

of Medicines& HealthCare

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This publication presents an overview of the Products and Services available in 2016 from the European Directorate for the Quality of Medicines & HealthCare, Council of Europe.

www.edqm.eu