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In the EAEU, a common medicines market is launched

In the EAEU, a common medicines market is launched


On May 6, 2017, after ratification by the EAEU countries of the regulatory framework for medicines circulation in the Union, a set of twenty-six documents prepared by the Commission in cooperation with the Member States enters into effect, including twenty-one decisions of the EEC Council, four decisions and one recommendation of the EEC Board.

"National medicines markets of the five Member States of the Eurasian Economic Union (EAEU) unify and start operating in the format of a single space," the Member of the Board - Minister of the Eurasian Economic Commission (EEC), Valery Koreshkov said. “Manufacturers of the Union countries will be able to apply for registration of medicines and their release under common procedures and reduce administrative costs.”  

An average consumer will notice changes in the pharmaceutical market later: this is due to the fact that it takes seven to ten months from the moment of filing a Drug Application for approval before releasing the drug into circulation and its sale.

The supranational regulations of the common market will be used for development, preclinical and clinical study, quality control, registration, manufacture and distribution of medicines. "The Commission, together with the best experts from the five Member States of the EAEU, has prepared all the necessary documents for the effective operation of the common medicines market, taking into account the world practice,” Valery Koreshkov said. “They are aimed at removing administrative barriers in manufacture and approval of medicines for circulation in the markets of the Union countries. These documents will also provide a distinctive "sanitization" of the pharmaceutical market, removing from it medicines, the efficacy and safety of which is not fully studied, but manufacture does not conform to the standards of good manufacturing practices.”

Matters related with the administration of approvals issue for preclinical and clinical studies of medicines, pricing of medicines and medical products, retail trade, public procurement of medicines and other procedures related to cost recovery in the circulation of medicines, regulation of medical advertising are left at the level of national regulation.

A transitional period ensuring a smooth transition from national to common regulation is provided for. This will prevent malperformance of health systems in the EAEU countries and help manufacturers of medicines to adapt to the new requirements as comfortable as possible. In particular, till December 31, 2020, the manufacturer has the right to choose under what regulations (national or common) it registers medicines. All medicines registered under national regulations till December 31, 2020 should pass re-registration under the regulations of the common market before December 31, 2025. When filing a Drug Application for registration before December 31, 2018, the manufacturer may provide national documents issued by the Union Member States that confirm compliance of manufacture of medicines with the requirements of national GMP instead of a GMP certificate of the EAEU.