Expert: the majority of EAEU registration files are rejected

As of early September, the unified information system of the Eurasian Economic Union contained about 100 applications for registration of medicinal products. The Unified Register of the Union contains information on 3 medicines that have already been registered within EAEU and another 4 on the wayto be added to the register – is the procedure is  carried out by Kazakhstan. This was announced by Dmitry Rozhdestvensky, Head of the Division for the Coordination of Work in the Field of Circulation of Medicinal Products and Medical Devices of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission, speaking at the summit “Pharmstrategy 2020”. The expert also noted that all five EAEU member states participate in the registration process: Russian Federation, Armenia, Belarus, Kazakhstan and Kyrgyzstan. These data will be updated during the next meeting of the relevant working group, at the end of October 2019.
The registration procedure of medicines under the unified rules of the EAEU started early March 2018. But so far, most of the files submitted for the registration have been rejected by the Commission for various reasons. For example, Russian Federation has  rejected 18 files.

As the first results of the analysis show, the main reasons for the rejection of the file are related to the fact that the set of files does not correspond to the classification of the Directory of Documents of the file, approved by the Eurasian Economic Commission, in the form of electronic codes that should be contained in each document included in the file,

– explained Dmitry Rozhdestvensky.

The first parts of the EAEU Pharmacopoeia is expected to be released next year. The first part of the first volume is planned to be released in January-February 2020, the second part of the first volume – in August 2020.