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Transition Period Towards a Common Format

10 may 2017 16:54

As we’ve already reported on May 6, 2017 the unified national pharmaceutical circulation markets in five states of the Eurasia Economic Union (EEU) began to work in the common space format. Manufacturers from the member-countries of the union had an opportunity to submit applications for marketing authorization of drugs and release according to unified global procedures. It will help reduce administrative costs.

Drugs will be developed according to supernational norms of the common market, preclinical and clinical trials, quality control, marketing authorization, production, and, finally sales will be made. Other questions (issue of permissions for studies of drugs, pricing, state purchase, advertising etc.) remain at the national regulatory level.

However, it is not so easy to begin working according to new standards of common regulation.That is why a transition period up to 2020 is provisioned. It will prevent failures in the work of healthcare systems in EEU countries and will enable players at the pharmaceutical market adjust to new requirements. Submitting a dossier for marketing authorization of drugs before December 31, 2018 the manufacturer may submit national documents, issued by the Union member-states and confirming compliance of manufacture to national GMP requirements, instead of EEU GMP certificate. Before December 31, 2020 the manufacturer remains free to choose what rules  to be guided by (national or unified) for approval of a new medicinal drug. However, it should be kept in mind. That all products authorized according to the national rules up to December 31, 2020, will have to pass a procedure of authorization renewal according to the regulations of the common market by December 31, 2025..

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