The Council of the Eurasian Economic Commission (EEC) has approved a new edition of the Rules of good pharmacovigilance practice (GVP) of the Eurasian Economic Union (EAEU). This is reported on the official website of the EEC.
“There are now detailed specifications of the pharmacovigilance processes for which the manufacturer of medicines is responsible. The possibilities of interaction between the manufacturer and the authorized bodies have been expanded. There are now more possibilities for using methods of active safety monitoring, as well as the use of labeling of unsafe medicines with special warning signs,” the report says.
The new edition takes into account the experience of pharmacovigilance of the EAEU countries and the best international approaches, the Eurasian Economic Commission stressed.
“The EEC Council has also made changes to the requirements for the instructions (package leaflet) on the use of human medicines. It is stipulated that it will include information with a warning about the safety of drugs obtained by human blood plasma processing. The document outlines unified approaches of drug manufacturers of the Eurasian Economic Union to the indication of special warnings about the security measures taken in relation to viral transmission with blood products. This will avoid possible differences in the examination of the text of the general characteristics of the medicinal product and the package leaflet for such medicines in the EAEU countries,” the EEC added.
As it became known earlier, early access to “breakthrough” drugs has become possible in the territory of the EAEU.
