The European Pharmacopoeia Commission

Опубліковано 10.07.2025 о 13:42

The European Pharmacopoeia Commission

The European Pharmacopoeia is a single reference work for the quality control of medicines in the signatory states of the Convention on the Elaboration of a European Pharmacopoeia.

The official standards published within provide a legal and scientific basis for quality control during the development, production and marketing processes.

They concern the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in production of medicines and on the intermediates of synthesis. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products in the signatory states of the Convention.

The European Pharmacopoeia Commission is the decision-making body of the European Pharmacopoeia and is responsible for the elaboration and maintenance of its content. The Ph. Eur. Commission adopts all the texts to be published in the Ph. Eur. and takes technical decisions by consensus.

The Commission is composed of the delegations representing the contracting parties to the Convention on the Elaboration of a European Pharmacopoeia, currently 39 member states and the European Union (EU).

Ukraine ratified the Convention in accordance with the law of Ukraine on Accession of Ukraine to the Convention on the Development of the European, as amended by the provisions of the Protocol thereto on 16.10.2012.

The Delegation of Ukraine was established by the Decree of the President of Ukraine No. 504/2020 dated 18.11.2020  On the Delegation of Ukraine to the Meetings of the European Commission on Pharmacopoeia. The main objectives of the Ukrainian delegation’s participation in the meetings of the European Commission on Pharmacopoeia are to ensure Ukraine’s interests in the development of pharmacopoeial quality standards for medicines. The results of joint developments become the basis for further harmonisation of the State Pharmacopoeia of Ukraine with the European Pharmacopoeia.  

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