New uniform rules for pharmaceutical circulation

Public discussions of three draft documents that set uniform rules for circulation of pharmaceuticals within the Eurasian Economic Union (EAEU) ended in July 2015. These draft documents are:

• “On pharmaceutical labeling requirements” (draft decision of the Eurasian Economic Commission (EEC) Council)
• “General requirements for the quality system of pharmaceutical inspectorates of the EAEU member states” (draft decision of the EEC Council)
• “Procedure for creating and maintaining the Unified Register of authorized persons of pharmaceuticals manufacturers in the Eurasian Economic Union” (draft decision of the EEC Council)

In accordance with the Treaty on the Eurasian Economic Union, the common pharmaceuticals market starts functioning from January 1, 2016. For purposes of performing the Treaty, the EEC is developing uniform rules pertaining to pharmaceuticals circulation, which will be in effect in the EAEU member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia) starting from 2016.

In particular, the EEC will adopt rules for proper laboratory, clinical and industrial practices, pharmaceutical trial requirements, requirements for the package insert information on medical use, and for the attestation procedure for authorized persons of pharmaceuticals manufacturers.

A unified information system of the EAEU will also be created to provide information on uniform requirements in the field of pharmaceutical circulation, data contained in the unified register and other information.

You can find texts of the abovementioned documents and other acts of the EEC on the official web site of the EAEU (https://docs.eaeunion.org/en-us/Pages/Regulation.aspx).

 

 

 

 

Dmitry Churin   Senior Associate   St. Petersburg       Tel.: +7 (812) 346 79 90

Gleb Apenkin   Associate    St. Petersburg       Tel.: +7 (812) 346 79 90

 

Additional notes

Should any questions arise in connection with the above or if you need any additional materials, please contact Dmitry Churin or Gleb Apenkin, St. Petersburg Office of Capital Legal Services.

This Information letter keeps the clients of Capital Legal Services and other interested parties abreast of information that may, to any extent, affect their activity or cater to their particular interests. The opinions and commentaries expressed in this information letter shall not be deemed as legal opinions and do not cancel the need to obtain legal advice or legal opinion on separate issues.