EAEU detailed pharmacovigilance processes

The Eurasian Economic Commission's Council has approved a new version of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union.

The pharmacovigilance processes for which the drug manufacturer is responsible have been detailed. The possibilities of interaction between the manufacturer and authorized bodies have been expanded. The possibilities to use methods of active safety monitoring and apply marking with specific warning signs of unsafe medicinal products have been enhanced.

The new version takes into account the Union countries' pharmacovigilance experience and the best international approaches.

The EEC Council has also amended the requirements for guidelines for medical use (medication guides) of medicines. It is stipulated that the guidelines will include information with a warning about the safety of products obtained by processing human blood plasma. The unified approaches of the Union countries' drug manufacturers to the indication of specific warnings about the safety measures taken to the transmission of viral agents with blood products have been outlined. This will allow avoiding possible differences when conducting an expert examination of the text of the summary of medicinal product characteristics and a package leaflet for such medicinal products in the Union countries.