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European Directorate for the
Quality of Medicines & HealthCare

European Directorate for the <br> Quality of Medicines & HealthCare
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  1. European Directorate for the Quality of Medicines & HealthCare
  2. Medicines
  3. European Pharmacopoeia (Ph. Eur.)
  4. The European Pharmacopoeia
  5. The European Pharmacopoeia - Membership & Observership

The European Pharmacopoeia - Membership & Observership

Membership

Membership enables states to participate in European Pharmacopoeia Commission sessions. Within these sessions, each state is represented by their national delegation consisting of not more than 3 members. On all technical matters delegations can cast a vote.

For all non-technical matters, the EU votes in place of its member states' delegations. Each member state can also propose national experts in each group of experts or working party.

European Pharmacopoeia Members

Albania, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Republic of Moldova, Montenegro, Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Republic of Türkiye, Ukraine, United Kingdom, and the European Union.

Latest members: Albania (2020), Republic of Moldova (2017).

Observership

Observership allows states to:

  • participate in the scientific work of the European Pharmacopoeia Commission;
  • benefit from the European experience in this area;
  • gain access to the work on the quality control of medicines and the methods of analysis used.

European Pharmacopoeia Observers

Algeria, Argentina, Armenia, Australia, Azerbaijan, Belarus*, Brazil, Canada, China, Ethiopia, Georgia, Guinea, India, Israel, Japan, Kazakhstan, Republic of Korea, Madagascar, Malaysia, Mexico, Morocco, Russian Federation*, Senegal, Singapore, South Africa, Syria, Tunisia, the United States of America, Uzbekistan, the Taiwan Food and Drug Administration (TFDA) and the World Health Organization (WHO).

Latest observers: Ethiopia (2022), Mexico (2020), Uzbekistan (2018), Japan (2016), India (2016).

* By decision of the Ministers’ Deputies of 17 March 2022, the rights of representation of Belarus as observer in the European Pharmacopoeia Commission have been suspended.

* By decision of the Ministers’ Deputies of 1 June 2022, the rights of representation of the Russian Federation as observer in the European Pharmacopoeia Commission have been suspended.

Latest updates

Latest member:

 Albania (2020)


Latest observer:

 Ethiopia (2022)

Additional information
  • List of countries that have ratified the European Pharmacopoeia Convention (ETS No. 50), 1964
  • Convention on the Elaboration of a European Pharmacopoeia (ETS No. 050)
  • Protocol to the Convention on the Elaboration of a European Pharmacopoeia (ETS No. 134), 1989
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