The Council of the Eurasian Economic Commission approved on 12.04.2024 Rules of pharmaceutical inspections for compliance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union
as well as the Rules for conducting pharmaceutical inspections for compliance with the requirements of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union, which complemented the decision of the EEC Council of November 3, 2016 № 83.

Currently, the authorized bodies of the Eurasian Economic Union states carry out inspections of the pharmacovigilance system of holders of registration certificates for medicinal products in accordance with the legislation of member states. In this regard, different approaches to conducting pharmaceutical inspections of the pharmacovigilance system may be applied, which may lead to non-recognition of the results of such inspections in certain EAEU countries.

The document approved by the Council of the Eurasian Economic Commission establishes general principles for conducting inspections of pharmacovigilance systems and interaction between authorized bodies of member states. Repeated (duplicate) inspections of drug manufacturers by each of the inspectors of member states are excluded.

As stated on the EAEU website, the adopted Rules for pharmaceutical inspections of the pharmacovigilance system are harmonized with the current version of the European Regulations and are based on the generalization and use of experience in assessing real problems of safety and efficacy of medicines in circulation on the pharmaceutical market of the Union.

In accordance with paragraph 2, the document shall enter into force after 30 calendar days from the date of official publication.