EAEU common market of medicines is based on European standards

| By | EAEU, GMP Standards

In May 2017, the markets of medicinal products and medical devices in the five member states of the Eurasian Economic Union (EAEU) received the legal right to start operating as a common economic space.

The matters of issuing permits for preclinical studies and clinical trials of drugs; pricing of medicinal products and medical devices; retail trade; public procurement of drugs and other procedures related to compensation of costs in the area of drug circulation; and regulation of advertizing will remain at the national regulation level.

There will be a transitional period to ensure a smooth transition from national to unified regulation. This will prevent disruptions in the functioning of health care systems of EAEU member states and help the manufacturers of drugs to adapt to new requirements as comfortably as possible. If a manufacturer submits the dossier for drug registration before December 31, 2018, it has the right to provide, instead of EAEU GMP certificate, the national documents issued by the member states of the Union and certifying the conformity of its manufacturing to the requirements of national GMP rules.

In fact, the common market of medicines in the Union will operate on the basis of European procedures for mutual recognition and decentralized procedures for registration of medicinal products. This includes the recognition of registration uniformity in all member states and the compliance of manufacturers with GxP requirements.