All documents of the Eurasian Economic Commission elaborated and enacted from May 6, 2017, are directly applicable documents. This means that they do not require the adoption of any national regulations governing their application in each of the member states. As a result, from May 6, all stages of developing, manufacturing, and assessing the medicinal products in preclinical studies and clinical trials should be conducted in accordance with the requirements of the relevant decisions adopted by the Commission.
Currently, for the registration of drugs, there is a transitional period until the end of 2020, during which the manufacturers may choose between registration of their medicinal products either in accordance with national legislation or according to the Union rules. Moreover, the authorities in the member states have no right to refuse to accept a dossier from the manufacturers of drugs for registration under the Union rules.
By December 31, 2025, all medicinal products registered in the member states under national procedures must have their dossier brought in line with the Union rules.
This may cause certain problems for those manufacturers in the Russian Federation who registered synthetic medicinal products for oral administration without conducting their clinical trials or bioequivalence studies, but solely on the basis of a literature review (the so-called “well-established drugs.”)