European Directorate for the Quality of

Medicines & HealthCare

The European Directorate for the Quality of Medicines &
HealthCare (EDQM) is a Directorate of the Council of Europe
European Directorate for
that traces its origins and statutes to the Convention on the the Quality of Medicines &
Elaboration of a European Pharmacopoeia (an international treaty HealthCare
adopted by the Council of Europe in 1964: ETS 50,[1]
Protocol[2]).

The signatories to the convention,[1] – 39 member states and the

European Union (EU) as of March 2020[3] – are committed to the
harmonisation of quality standards for safe medicines throughout
the European continent and beyond. In addition to the member
states there are currently 30 observers, including the World Health
Organization (WHO) and the Taiwan Food and Drug
Administration (TFDA). The EDQM's quality standards for EDQM Building, Strasbourg
medicines are published in the European Pharmacopoeia (officially Abbreviation EDQM
abbreviated to Ph. Eur.), which is recognised as a scientific
Predecessor European
benchmark worldwide and is legally binding in member states.[3]
Pharmacopoeia
The EU pharmaceutical legislation refers directly to the Ph. Eur. (1964-1996)
and to other activities for which the EDQM is responsible (e.g. the European
Certification procedure or “CEP" and the OMCL Network – see Department for the
below), demonstrating the shared commitment of the European Quality of
organisations to public health protection.
Medicines (1996-
The EDQM is also involved in a number of international 2007)
collaboration and harmonisation initiatives, such as the Formation 1964
Pharmacopoeial Discussion Group (PDG),[4] the International
Type Administrative
Pharmaceutical Regulators Programme (http://www.iprp.global/ho
me) (IPRP), the International Council for Harmonization of entity of the
Technical Requirements for Pharmaceuticals for Human Use (http Council of Europe
s://www.ich.org/) (ICH), the International Meeting of World Purpose Protection of public
Pharmacopoeias (https://web.archive.org/web/20141009000711/htt health
p://www.who.int/medicines/areas/quality_safety/quality_assurance/
Headquarters Strasbourg,
resources/qas_worldpharmmeeting/en/) (IMWP), the
Pharmaceutical Inspection Convention and Pharmaceutical France
Inspection Co-operation Scheme (https://picscheme.org/) (PIC/S) Director Petra Dörr
and the International API Inspection Programme[5] (co-ordinated Staff Over 340 (as of
by the European Medicines Agency, or EMA). February 2020)
In addition, the EDQM works closely with World Health Website www.edqm.eu (htt
Organization (WHO) on the establishment, monitoring and ps://www.edqm.eu)
distribution of WHO International Standards for Antibiotics
(ISA)[6] and WHO International Chemical Reference Substances (ICRS)[7] which are necessary to apply
the tests described in the WHO International Pharmacopoeia (https://archive.today/20121212002931/http://
apps.who.int/phint/en/p/about/).

The EDQM therefore plays an essential role in the complex regulatory framework for medicines in Europe.
Its primary purpose is to protect public health by enabling the development, supporting the implementation
and monitoring the application of quality standards for safe medicines and their safe use.

Contents
The EDQM’s mission
Leadership
Activities related to the quality of medicines
The European Pharmacopoeia: setting quality standards for Europe and beyond and
supplying pharmaceutical reference standards
The Certification procedure:[16] evaluating the quality of active ingredients and excipients
and inspecting manufacturing sites
The OMCL Network: quality control of medicines on the market[8]
Pharmaceutical care and combating falsified medical products
Activities related to patient and consumer protection
Blood transfusion
Organ, tissue and cell transplantation
Cosmetics and food contact materials
References
External links

The EDQM’s mission

Within the Council of Europe, the EDQM's mission is to contribute to the basic human right of access to
good quality medicines and healthcare, and to promote and protect human and animal health by:

establishing and providing official standards for the manufacture and quality control of
medicines in all the signatory states of the Convention on the Elaboration of a European
Pharmacopoeia,[1] and beyond;
granting Certificates of suitability to manufacturers whose pharmaceutical substances
comply with Ph. Eur. standards, and carrying out inspections of the manufacturing sites
concerned;
co-ordinating a network of Official Medicines Control Laboratories (OMCLs)[8] to collaborate
and share expertise between member states and optimise the use of available resources,
with the aim of achieving effective independent quality control of medicines in Europe and
beyond;
proposing ethical, safety and quality standards for blood transfusions (collection,
preparation, storage, distribution and appropriate use of blood components)[9] and the
transplantation of organs, tissues and cells;[10]
working with national, European and international organisations in the fight against
falsification of medical products and similar crimes;[11]
 providing policies and model approaches for the safe use of medicines in Europe, including
guidelines on pharmaceutical care; and
establishing standards for cosmetics and food contact materials and articles, and co-
ordinating the independent control of cosmetics.

Leadership
Directors:

Petra Dörr (as of 1 October 2021)[12]

Susanne Keitel (1 October 2007 - 30 September 2021)
Agnès Artiges (1994 - 31 July 2007)

Activities related to the quality of medicines

The European Pharmacopoeia: setting quality standards for Europe and

beyond and supplying pharmaceutical reference standards

Published and regularly updated by the EDQM/Council of Europe in English and French, the two official
languages of the Council of Europe, the Ph. Eur. is a compendium of official quality standards for
medicines and their ingredients. It thus helps define the requirements to be met by manufacturers seeking to
obtain Marketing Authorisation (MA) for a (human or veterinary) medicinal product in Europe, but its
standards are also recognised and used worldwide as a scientific benchmark in the field of quality control
for human and veterinary medicines.

These common harmonised quality standards – known as monographs – describe strict specifications for
medicines and the substances used in their manufacture, that apply throughout the product's entire life
cycle. When adopted, they are legally binding and become mandatory on the same date in the 39 European
countries[3] that are signatories to the Ph. Eur. convention,[1] applying to all medicines on their markets.

The contents of the Ph. Eur. are elaborated and updated by the Ph. Eur. Commission,[13] which is
responsible for overseeing the practical work of more than 800 experts in every field of the pharmaceutical
sciences – all volunteers – who participate in currently 61 groups of experts and working parties. The Ph.
Eur. Commission[13] decides on the work programme,[14] appoints the experts and adopts the monographs
and other texts that comprise the Ph. Eur. (Articles 6 and 7, Ph. Eur. convention.[1] It meets three times a
year in Strasbourg (France) and takes all technical decisions by a unanimous vote. The EDQM provides the
scientific secretariat and logistical support for the work of the Ph. Eur. Commission,[13] and facilitates the
activities of its groups of experts and working parties.

The texts of the Ph. Eur. cover all therapeutic areas and comprise:

individual monographs describing legally binding quality standards for medicines and the
ingredients used in their manufacture (active ingredients, excipients, herbals, etc.);
individual monographs describing legally binding quality standards for medicinal products;
general monographs describing legally binding quality standards for classes of substances
(such as fermentation products or substances for pharmaceutical use) or for the different
dosage forms that medicines can take (tablets, capsules, injections, etc.); and,
general methods of analysis for substances used in the manufacture of medicines, which are
not legally binding and may also be used for substances and medicines not described in the
 Ph. Eur.

All the analytical methods described in the monographs are experimentally verified. In addition, the EDQM
is responsible for establishing and supplying the official reference standards without which it would be
impossible to carry out many of the mandatory quality control tests described in the Ph. Eur. These physical
standards are used by manufacturers located both in Europe and around the world, and national and
European authorities involved in the quality control of medicines, to name but a few. The EDQM publishes
a new edition of the Ph. Eur. every three years.

The current Chair of the commission is Professor Torbjörn Arvidsson, who was elected in March 2019 for
three years.[15]

The Certification procedure:[16] evaluating the quality of active ingredients

and excipients and inspecting manufacturing sites

The EDQM runs a quality evaluation programme for active ingredients and excipients used in the
manufacture of medicines. The Certification of Suitability[17] to the Monographs of the European
Pharmacopoeia procedure was initially set up in 1992 as a pilot programme but went on to become routine
for chemical substances in 1994; it was expanded in 2003 to include herbal drugs (active substances
obtained from plants).[18] Granted after an assessment of the documentation submitted by the applicant, a
Certificate of Suitability (CEP)[17] provides proof that the methods used by a manufacturer or distributor
result in an product whose quality complies with the requirements laid down in the corresponding Ph. Eur.
monograph(s). The EDQM also runs an inspection programme for CEP-holders, targeting their
manufacturing and/or distribution sites.

The Certification procedure[16] is not compulsory: it is a service that is offered to manufacturers who can
submit their CEP[17] in the quality section of a new marketing authorisation (MA) application or a variation
of an existing MA. It serves to centralise the evaluation of data for the benefit of both regulatory authorities
and industry, thus saving time and resources.

A further advantage of the Certification procedure[16] is that it provides the Ph. Eur. Commission[13] with
up-to-date information on the quality of substances on the European market, highlighting where Ph. Eur.
texts and quality requirements might require revision and helping to ensure that the pharmacopoeia remains
state-of-the-art.

CEPs[17] – which are referred to in EU pharmaceutical legislation – are accepted by the Ph. Eur. member
states[3] and by a number of other countries and regions, including Australia, Canada, New Zealand, Saudi
Arabia, Singapore, South Africa, Taiwan and Tunisia. An increasing number of licensing authorities
worldwide accept CEPs[17] to support (fully or partially) the data related to the quality of active ingredients
used in medicinal products.

As previously stated, a CEP[17] is granted after members of the EDQM's panel of assessors (drawn from
national medicines agencies throughout Europe) have reviewed a detailed dossier submitted by the
manufacturer. This dossier describes the manufacturing process and the tests performed on the raw
materials and on the substance produced, as well as the necessary in-process controls. The manufacturer
must demonstrate that the article complies with the quality standards laid down in Ph. Eur. and the EU
legislation and that the monograph can be used to control impurities, unwanted chemicals that can be
present in a substance for a variety of reasons. The applicant must also agree to comply with the relevant
EU Good Manufacturing Practice guidelines (GMP guide) as defined in Part II of the GMP Guide,[19] and
to accept an on site inspection at any time at the request of the EDQM.
The OMCL Network: quality control of medicines on the market[8]

On 26 May 1994, the European Commission and the Council of Europe decided to launch a new, jointly
funded, co-operative venture targeting the quality control of medicines for human and veterinary use on the
market, called the European Network of Official Medicines Control Laboratories (OMCLs).[8] Open to
both member states and observers[3] of the Ph. Eur. convention,[1] this network is made up of independent
public laboratories that have been appointed by their respective national authorities. Their primary mission
is to ensure, through random sample testing, that medicines supplied to patients – wherever they are in
Europe – comply with the applicable quality standards and the terms and conditions of their MA.

The laboratories that form the network share resources, expertise and workloads: this not only contributes
to reducing public health expenditure, a broader coverage of medicines on the market and to the
development of future harmonised common standards, but means that laboratories across Europe have
access to state-of-the-art technology and selective analytical procedures.

Nowadays many laboratories within the network have seen a significant shift from medicines on the market
testing to the analysis of falsified and illegal medicines on behalf of other authorities such as customs,
police, enforcement/food inspectors and courts.

The EDQM is responsible for co-ordinating the network's technical activities and ensuring the smooth
running of its various joint programmes.

The OMCL Network[8] performs studies on medicinal products already on the market (market surveillance
studies). The EDQM organises inter-laboratory testing activities for OMCLs[8] to improve their analytical
performance (proficiency testing scheme [PTS][20] studies and promotes common quality management
systems in all OMCLs[8] to enable work-sharing and mutual recognition of test results.

The EDQM also provides the technical secretariat for the Official Control Authority Batch Release
(OCABR)[21] procedures for human and veterinary immunological medicinal products (e.g. vaccines) and
human blood-derived medicinal products (e.g. clotting factor, immunoglobulin, albumin. For example, the
OCABR[21] procedure guarantees that for the vast majority of the vaccines used in the EU, no batch of
vaccine is released to the market in member states without first undergoing an independent quality control
by a laboratory of the OMCL Network[8] in addition to the release test conducted by the manufacturer.

Pharmaceutical care and combating falsified medical products

According to WHO,[22] it is estimated that half of all medicines worldwide are inappropriately prescribed,
dispensed or sold, and that half of all patients fail to take their medicines properly. Errors related to
medication use, lack of documentation on how medicines are prescribed, used and dispensed, as well as
insufficient communication have a considerable impact on national mortality and morbidity rates.
Therefore, the safe and appropriate use of medicines, which depends on the right information being
available to those that need it, is as important as product quality.

In order to face this challenge while taking into account current constraints on public health budgets and
social inequality in access to healthcare, the European Committee on Pharmaceuticals and Pharmaceutical
Care (CD-P-PH),[23] which is co-ordinated by the EDQM, oversees the work of experts in three main
areas:

The classification of medicines authorised in Europe into prescription and non-prescription

medicines: although the responsibility for classifying medicines lies with the individual
member state, the CD-P-PH issues classification recommendations. These
 recommendations may also cover medicines that are not licensed for use in the EU, since
the EDQM has a broader membership and CD-P-PH members include representatives of
member states that are not part of the EU. The recommendations are updated annually and
published on the EDQM's website. The EDQM also hosts the publicly available Melclass
database,[24] which presents the classification status of medicines in Ph. Eur. member
states.
Setting quality and safety standards in pharmaceutical practices and pharmaceutical care:
public authorities and the pharmaceutical industry devote much of their resources to
ensuring the quality, safety and efficacy of medicines. However, the best treatment outcomes
are only achieved when medicines are used safely and appropriately. The CD-P-PH
develops scientific indicators to measure the quality of pharmaceutical care in Europe, a
concept defined as “the responsible provision of drug therapy for the purpose of achieving
definite outcomes that improve a patient’s quality of life”. The indicators developed by the
EDQM provide practical information that is of use to policymakers and professional
associations on a daily basis, helping to make healthcare systems more responsible and
cost-effective.
Preventing and managing risks posed by falsified medical products: falsified medical
products pose a growing and real threat to public health in Europe and world-wide. Falsified
medicines and medical devices may contain poor quality ingredients, the wrong dosage of
an active substance, a different active substance or even a poisonous substance, they may
be deliberately mislabelled or have fake packaging or ingredients. To combat this problem,
the Council of Europe established the MEDICRIME Convention (CETS No. 211),[11] the first
international treaty to criminalise the falsification of medical products and similar crimes with
a view to protecting public health. The convention entered into force on 1 January 2016.

Activities related to patient and consumer protection

Blood transfusion

The work of the EDQM in the area of blood transfusion is co-ordinated by the European Committee on
Blood Transfusion (CD-P-TS),[25] which consists of representatives from authorities working in the field of
blood transfusion or at national blood establishments (BEs) from member states of the Council of Europe
and observers such as the European Commission, WHO, the USFDA and the Council of Europe's
Committee on Bioethics (DH-BIO).[26] These experts work together on the ethical, legal and organisational
aspects of blood transfusion with a view to ensuring quality, increasing availability, avoiding wastage,
ensuring optimal use of blood supplies and analysing the possible ethical and organisational impact of new
scientific developments. One outcome of this work, the “Guide to the preparation, use and quality
assurance of blood components”,[27] provides recommendations on blood collection, blood components,
technical procedures, transfusion practices and quality systems for BEs.

Through its Blood Proficiency Testing Scheme[28] and Blood Quality Management Programme[29] the
committee helps Council of Europe member states improve their blood transfusion services, ensuring the
transfer of knowledge and expertise through training and networking and the monitoring of practices in
Europe. They also assess epidemiological risks, in particular those related to the emergence of new
infectious agents transmissible by blood transfusion.

Organ, tissue and cell transplantation

The work of the Council of Europe in the area of organ, tissue and cell transplantation began in 1987. The
guiding principles for the EDQM's activities in this area are ensuring human dignity, maintaining and
fulfilling human rights and fundamental freedoms, non-commercialisation of substances of human origin
and protecting donors and recipients of organs, tissues and cells. This latter principle is fulfilled by
improving and promoting strict standards for quality and safety in order to protect not only the donor and
recipient, but also the precious donated organ/tissue itself.

The European Committee on Organ Transplantation (CD-P-TO)[30] is the steering committee in charge of
transplantation activities). This committee consists of representatives from member states of the Council of
Europe, and observers including the European Commission, WHO, the DH-BIO, Eurotransplant,
Scandiatransplant, the European Society for Organ Transplantation (ESOT), The Transplantation Society
(TTS), the European Association of Tissue and Cells Banks (EATCB), the European Eye Bank
Association (EEBA), the European Society of Human Reproduction and Embryology (ESHRE) and the
World Marrow Donor Association (WMDA). It actively promotes the non-commercialisation of donation,
the fight against organ/tissue and cell trafficking and the development of ethical, quality and safety
standards in the field of organ, tissue and cell transplantation. An important part of the CD-P-TO's work is
the development and publication of two major guides: the “Guide to the quality and safety of organs for
transplantation”[31] and the “Guide to the quality and safety of tissues and cells for human application”.[31]

The EDQM organises a European Day for Organ Donation and Transplantation (EODD)[32] together with
a different member state every year, to raise awareness of the importance of organ donation and
transplantation in its member states and to encourage public debate and reflection on this life-saving
therapy.

Cosmetics and food contact materials

Since 1 January 2009, the EDQM has worked on strengthening consumer health protection in Europe, with
a focus on the safe use and quality of cosmetics and materials and articles in contact with foodstuffs.

The European Committee on Cosmetics and Consumer Health (CD-P-COS)[33] is tasked with responding
to emerging risks for health arising from the use of cosmetics. By promoting the principles laid down in
Council of Europe Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and
permanent make-up,[34] the committee also works to ensure the safety of these products. Activities on the
work programme focus on fostering collaboration between member states and observers.

The CD-P-COS[33] oversees the European Network of Official Cosmetics Control Laboratories
(OCCLs).[35] This network was established in 2010 to maximise the efficiency of cosmetics surveillance
by strengthening cross-border collaboration and pooling resources to perform Europe-wide market
surveillance studies. Several control laboratories in Asia also take part.

In addition to market surveillance studies, network activities include analytical development, PTS studies
and the implementation of harmonised quality management systems. Priority is given to testing products
that may present a health risk for consumers, either linked to the presence of prohibited or restricted
substances (according to EU legislation) or trace metals. The network also publishes test methods after
performing inter-laboratory trials to confirm that these methods are fit for purpose.

The European Committee for Food Contact Materials and Articles (CD-P-MCA)[36] is tasked with
developing and strengthening harmonised measures that supplement EU and national legislation to ensure
the safety of packaging, containers, utensils and other materials and articles for food contact. It is supported
by two subordinate bodies: the working group on food contact materials made from paper and board and
the working group on printed food contact materials. The technical guides published by the CD-P-
MCA[36] are used as reference documents by manufacturers and other business operators, safety evaluators
and control laboratories.

References
1. Council of Europe. "Convention on the Elaboration of a European Pharmacopoeia, ETS No.
50" (https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/050). Council of
Europe Treaty Office.
2. Council of Europe. "Protocol to the Convention on the Elaboration of a European
Pharmacopoeia, ETS No. 134" (https://www.coe.int/en/web/conventions/full-list/-/convention
s/treaty/134). Council of Europe Treaty Office.
3. EDQM. "List of Ph. Eur. Members & Observers" (https://www.edqm.eu/en/list-ph-eur-member
s-observers). www.edqm.eu.
4. EDQM. "International harmonisation" (https://www.edqm.eu/en/international-harmonisation).
www.edqm.eu.
5. EDQM. "International API Inspection Programme" (https://www.edqm.eu/en/inspection-progr
amme-certification-159.html). www.edqm.eu.
6. EDQM. "WHO International Standards for Antibiotics (ISA) : Purpose & Use" (https://www.ed
qm.eu/en/who-international-standards-antibiotics-isa-purpose-use). www.edqm.eu.
7. EDQM. "WHO International Chemical Reference Substances (ICRS) : Purposes & Use" (htt
ps://www.edqm.eu/en/WHO-ICRS-Reference-Substances-1393.html). www.edqm.eu.
8. EDQM. "General European OMCL Network (GEON)" (https://www.edqm.eu/en/general-euro
pean-omcl-network-geon). www.edqm.eu.
9. EDQM. "European Committee on Blood Transfusion (Steering Committee) (CD-P-TS)" (http
s://www.edqm.eu/en/blood-transfusion-mission.html). www.edqm.eu.
10. EDQM. "European Committee on Organ Transplantation (CD-P-TO)" (https://www.edqm.eu/
en/organ-transplantation-work-programme-72.html#:~:text=The%20mission%20of%20the%
20CD%2DP%2DTO%20is%20to%3A&text=Assist%20member%20states%20in%20improvi
ng,safety%20standards%20and%20their%20implementation.). www.edqm.eu.
11. Council of Europe. "Council of Europe Convention on the Counterfeiting of Medical
Products, CETS No. 211" (https://www.coe.int/en/web/conventions/full-list/-/conventions/trea
ty/211). Council of Europe Treaty Office.
12. "The Council of Europe appoints future EDQM Director | EDQM - European Directorate for
the Quality of Medicines" (https://www.edqm.eu/en/news/council-europe-appoints-future-edq
m-director). www.edqm.eu. Retrieved 15 September 2021.
13. EDQM. "The European Pharmacopoeia Commission" (https://www.edqm.eu/en/european-p
harmacopoeia-commission). www.edqm.eu. Retrieved 19 January 2021.
14. EDQM. "Work Programme for the European Pharmacopoeia" (https://www.edqm.eu/en/euro
pean-pharmacopoeia-work-programme-607.html). www.edqm.eu. Retrieved 19 January
2021.
15. EDQM, "Outcome of the 163rd Session of the European Pharmacopoeia Commission -
Press release" (https://www.edqm.eu/sites/default/files/press_release_ph_eur_commission_
163rd_session_march_2019.pdf), www.edqm.eu, 28 March 2019
16. EDQM. "Certification Policy Documents & Guidelines" (https://www.edqm.eu/en/certification-
policy-documents-guidelines). www.edqm.eu.
17. EDQM. "Certification of Suitability to the monographs of the European Pharmacopoeia -
Background & Legal Framework" (https://www.edqm.eu/en/certification-background-
77.html). www.edqm.eu. Retrieved 19 January 2021.
18. "Resolution AP-CSP (07) 1 (adopted by the Public Health Committee (Partial Agreement)
(CD-P-SP) on 21/02/2007) Certification of suitability to the monographs of the European
Pharmacopoeia (revised version)s" (https://www.edqm.eu/medias/fichiers/cep_procedure_re
vised_version.pdf)
19. "Guidance on good manufacturing practice and good distribution practice: Questions and
answers" (https://www.ema.europa.eu/en/human-regulatory/research-development/complian
ce/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-pr
actice-questions-answers)
20. EDQM. "Physico-chemical and Biological PTS" (https://www.edqm.eu/en/physico-chemical-
and-biological-pts). www.edqm.eu. Retrieved 19 January 2021.
21. EDQM. "Batch Release for Human Biologicals: vaccines, blood and plasma derivatives" (htt
ps://www.edqm.eu/en/batch-release-human-biologicals-vaccines-blood-and-plasma-derivati
ves). www.edqm.eu. Retrieved 19 January 2021.
22. WHO. "Promoting rational use of medicines" (https://www.who.int/activities/promoting-ration
al-use-of-medicines/). www.who.int. Retrieved 19 January 2021.
23. "Mandate of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-
PH)" (https://rm.coe.int/0900001680992cd5)
24. "Melclass Database" (https://melclass.edqm.eu/)
25. "Terms of reference of the European Committee on Blood Transfusion (CD-P-TS)" (https://r
m.coe.int/cd-p-ts-2020-2021-en/1680992cd3)
26. Council of Europe. "Committee on Bioethics (DH-BIO)" (https://www.coe.int/en/web/bioethic
s/dh-bio). www.coe.int. Retrieved 19 January 2021.
27. EDQM (2020). "Guide to the preparation, use and quality assurance of blood components,
20th edn" (https://www.edqm.eu/en/blood-guide). www.edqm.eu. Retrieved 19 January
2021.
28. EDQM. "Blood Proficiency Testing Scheme (B-PTS)" (https://www.edqm.eu/en/blood-profici
ency-testing-scheme-b-pts). www.edqm.eu. Retrieved 19 January 2021.
29. EDQM. "Blood Quality Management Programme (B-QM)" (https://www.edqm.eu/en/blood-qu
ality-management-programme-b-qm). www.edqm.eu. Retrieved 19 January 2021.
30. "European Committee on Organ Transplantation (CD-P-TO)" (https://www.edqm.eu/sites/def
ault/files/terms_of_reference_of_the_european_committee_on_organ_transplantation_2018
-2019.pdf)
31. EDQM. "Organs, Tissues and Cells - Technical Guides" (https://www.edqm.eu/en/organs-tiss
ues-and-cells-technical-guides). www.edqm.eu. Retrieved 19 January 2021.
32. EDQM. "European Day for Organ Donation and Transplantation" (https://www.edqm.eu/en/e
uropean-day-organ-donation-and-transplantation-9-october-2021). www.edqm.eu. Retrieved
19 January 2021.
33. "Terms of Reference of the European Committee for Cosmetics and Consumer Health" (http
s://rm.coe.int/cd-p-cos-2020-2021-en/1680992cd8)
34. Council of Europe, Committee of Ministers (20 February 2008). "Resolution ResAP(2008)1
on requirements and criteria for the safety of tattoos and permanent make-up (superseding
Resolution ResAP(2003)2 on tattoos and permanent make-up)" (https://search.coe.int/cm/Pa
ges/result_details.aspx?ObjectId=09000016805d3dc4). www.coe.int. Retrieved 19 January
2021.
35. EDQM. "The Network of Official Cosmetics Control Laboratories (OCCLs)" (https://www.edq
m.eu/en/network-official-cosmetics-control-laboratories-occls). www.edqm.eu. Retrieved
19 January 2021.
36. EDQM. "Terms of reference for the European Committee for Food Contact Materials and
Articles (CD-P-MCA)" (https://rm.coe.int/cd-p-mca-2020-2021-en/1680992cd7). www.coe.int.
Retrieved 19 January 2021.

External links
EDQM Official Website (https://www.edqm.eu/)
Council of Europe (https://web.archive.org/web/20141022214407/http://hub.coe.int/)
European Medicines Agency (EMA) (http://www.ema.europa.eu/)
EU Commission (http://ec.europa.eu/index_en.htm)
European Public Health (http://ec.europa.eu/health/index_en.htm)

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