Moscow Region’s Alium certified under EAEU GMP
12.04.2022
Alium, a Moscow Region plant belonging to pharmaceutical company Binnopharm Group (part of Sistema Group), has obtained the Eurasian Economic Union's good manufacturing practice (GMP) certificate. The Company’s Stavropol facility Biocom has also been certified recently, and the rest of Binnopharm Group's sites are currently undergoing licensing inspections for compliance with the EAEU’s GMP rules.
“Certification for EAEU GMP compliance means the plant has a well-functioning pharmaceutical quality system in place and its medicines are guaranteed to be safe and efficacious. This certificate opens the door for marketing medicines in the EAEU's member states under uniform product quality, effectiveness and safety regulations,” said Binnopharm Group's CEO Rustem Muratov. “The EAEU GMP certification is a big step towards a common pharmaceutical market across the EAEU.”
According to the resolution of the Council of the Eurasian Economic Commission (EEC), starting January 2022, only the manufacturers that have been certified under the common EAEU rules may register medicines in the EAEU's member states. The GMP certificate is recognised by EAEU member states and allows for registering and selling medicines in Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. In Russia, the authorised body carrying out the respective inspections is the Ministry of Industry and Trade.
“Certification for EAEU GMP compliance means the plant has a well-functioning pharmaceutical quality system in place and its medicines are guaranteed to be safe and efficacious. This certificate opens the door for marketing medicines in the EAEU's member states under uniform product quality, effectiveness and safety regulations,” said Binnopharm Group's CEO Rustem Muratov. “The EAEU GMP certification is a big step towards a common pharmaceutical market across the EAEU.”
According to the resolution of the Council of the Eurasian Economic Commission (EEC), starting January 2022, only the manufacturers that have been certified under the common EAEU rules may register medicines in the EAEU's member states. The GMP certificate is recognised by EAEU member states and allows for registering and selling medicines in Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. In Russia, the authorised body carrying out the respective inspections is the Ministry of Industry and Trade.
