00:49
+32
USD 68.85
EUR 79.21
RUB 1.17
English

Medicines can be registered under national laws and EEU until end of 2020

Producers of medicines from the EEU countries can choose how to register medicines by the end of 2020, according to national legislation or the rules of the union, the EEC reported.

All EEC documents developed and enacted since 6 May 2017 are direct instruments. This means that they don’t require the adoption of any national regulations governing their application in each of the Member States. Thus, starting from May 6, all stages of development, production, and treatment in pre-clinical and clinical trials should be carried out in accordance with the requirements of the EEC decisions.

Currently, with respect to the registration of medicines by the end of 2020, there is a transitional period, during which each producer has the right to choose — to register the medicinal product in accordance with national legislation or according to the rules of the union. At the same time, the authorized bodies of the Member States have no right to refuse to the producers of medicines in accepting the registration dossier according to the rules of the EEU.

Until December 31, 2025, all proportional drugs registered in the Member States for each process must comply with your dossier in accordance with the rules of the union.

This can cause certain difficulties in Russia, which register synthetic drugs for oral administration without performing clinical or bioequivalent studies, solely on the basis of the submission of literature reviews in the union registration rules for such decisions.

Within the framework of the EEU, a single drug registration authority will not be established, such as the European Medicines Agency in the European Union (EMA) or the Food and Drug Administration in the United States (FDA). Powers for registration and control over the circulation of medicines at the level of the member states of the Union.

Popular