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The period of validity of the national procedure for registration of medicines has been extended until the July 1, 2021
On the EEU legal support website a decision of the Council of the Eurasian Economic Commission dated December 23 has been published stating that pharmaceutical manufacturers are granted a 6-month extension period (until July 1, 2021) to choose to register new medicinal products under national procedures in four union states (the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan and the Kyrgyz Republic).
This means that starting from January 1 to June 30, 2021, it will still be possible to register medicinal products under national procedures in the above countries. June 30, 2021, will be the last day for applicants to apply for registration of new medicinal products in accordance with the legislation of the EAEU states. One of the main transition periods of the common market for medicinal products for human use will be completed.
Starting from July 1, 2021 (January 1, 2021 in the Russian Federation), new medicinal products (i.e., medicinal products without valid Registration Certificates/Marketing Authorisation of the Member States of the Union) may only be registered in accordance with the Rules for the Registration and Expert Examination of Medicinal Products for Human Use approved by Decision No. 78 of the EEC Council dated November 3, 2016.
Manufacturers who have not yet taken the necessary steps in this regard need to plan the process of making changes to registration dossiers to ensure transition to supranational regulation, choose a reference state for conducting an expert examination of all dossier materials and laboratory assessment of the medicinal product quality, and submit documents for the procedure for harmonizing with the requirements of international treaties and acts constituting the law of the Union, by December 31, 2025.
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