National markets of drug circulation in EAEU share a common format


On 6 May, 2017, a package of twenty-six documents prepared by the Commission together with the member states, including twenty one decisions of the EEC Council, four decisions and one recommendation of EEC Board, takes effect after the ratification by EAEU member states of the regulatory framework for regulating the drug circulation in the Union.

The supranational regulations of the common market will govern the development, preclinical studies and clinical trials, quality control, registration, manufacturing and distribution of medicinal products.

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 medicinal products to adapt to new requirements as comfortably as possible. In particular, until December 31, 2020, the manufacturers have the right to select whether they will register the drugs under national or common rules. All medicinal products registered under the national rules before December, 31 2020, must go through re-registration procedure under the common market rules by December 31, 2025. 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.