12.04.2024 (Обновлено: 17.04.2024 10:48)

EAEU adopted uniform Rules for pharmaceutical inspections of pharmacovigilance systems of medicine manufacturers

At its meeting held on April 12, the Eurasian Economic Commission's Council supplemented Decision No. 83 of the EEC Council dated November 3, 2016 with the Rules for pharmaceutical inspections for compliance with the requirements of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union.

Valentin Tataritsky, EEC Minister in charge of Technical Regulation, noted: "The amendments are aimed at preserving medicines with a proven positive benefit-risk profile in circulation in the Union's pharmaceutical market and excluding from circulation and production those medicines that pose a threat to public health and well-being of the population".

Nowadays, the authorized bodies of the Eurasian Economic Union States inspect the pharmacovigilance system of marketing authorization holders in accordance with the Member States' legislation. This creates the prerequisites for different approaches to pharmaceutical inspections of the pharmacovigilance system and possible non-recognition of the inspection results in some EAEU countries.

The document adopted by the EEC Council establishes unified approaches to the procedures for conducting inspections of pharmacovigilance systems and interaction between the Member States' authorized bodies. Repeated (duplicate) inspections of medicine manufacturers by each of the Member States' inspectorates are eliminated, which will make it possible to optimize inspection resources.

The Rules for pharmaceutical inspections of the pharmacovigilance system are harmonized with the current version of the European Rules and are based on the best practice and use of experience in assessing real issues of safety and efficacy of medicinal products circulating in the Union's pharmaceutical market.