On June 21, the amendments to the Rules for Marketing Authorization and Expert Examination of Medicinal Products for Human Use approved by the Council of the Eurasian Economic Commission come into force.

"These amendments are an important step to finalize the transition to a unified approach to marketing authorization of medicines in the Eurasian Economic Union. We strive to minimize administrative barriers for manufacturers and at the same time protect the interests of patients who should receive high-quality and safe medicines," mentioned Valentin Tataritsky, the EEC Minister in charge of Technical Regulation.

The new provisions are aimed at harmonizing authorization processes in the Union countries, completing the work on the procedure for bringing marketing authorization applications in line with the EAEU requirements and ensuring patients' uninterrupted access to medicines.

The amendments cover the procedure for bringing marketing authorization applications for medicinal products in line with the EAEU requirements and for conducting pharmaceutical inspections of manufacturers initiated in the course of authorization procedures.

Also, in order to accelerate the transition to EAEU regulation, restrictions on the simultaneous performance of procedures for mutual recognition and making amendments to a marketing authorization application for a medicinal product have been removed.