The Board of the Eurasian economic Commission adopted the Pharmacopoeia of the EEU, which will be the a single to evaluate the quality of medicines in five allied countries. Pharmacopoeia of the EEU was the second regional Pharmacopoeia in the world. The document will take effect from 1 March 2021, according to the website of the EEC.
Manufacturers of medicinal products previously registered in the common market of the EEU, have until January 1, 2026 shall bring its normative documents in line with the new Pharmacopoeia.
The first part of the first volume of the approved Pharmacopoeia includes 157 harmonized General Pharmacopeia articles (monographs) that provides General information about the use of the Pharmacopoeia analysis and its techniques, methods, biological and microbiological tests, reagents, instruments and devices for quality analysis as already traded on the market, and new, emerging drugs. Plans – filling the document of the new General and particular articles with the preparation of the publication of the following volumes.
“Monograph is harmonized with the leading pharmacopoeias of the world, and this will ensure continuity in research of quality of medicines and facilitate the withdrawal of pharmaceutical products Union on foreign markets”, – said the member of the Board (Minister) for technical regulation of the EEC Viktor Nazarenko.
The creation of a common Pharmacopoeia was the result of three years of labor. Monograph prepared by the Pharmacopoeia Committee of the EAEC, taking into account national pharmacopoeias of member States, regional Pharmacopoeia of the European Union. Now Pharmacopoeia Committee of the EAEU prepared more than 100 articles of the Pharmacopoeia to Pharmacopoeia.