News
As of December 20, drug product manufacturers to be able to arrange circulation of medicinal products under unified rules of EAEU common market in a simplified manner
On December 20, changes to the Rules for Marketing Authorization and Expert Examination of Medicinal Products for Human Use come into effect, simplifying the procedure for bringing Marketing Authorization Applications in compliance with the requirements of the Eurasian Economic Union.
The changes accommodate the consolidated proposals of the business community and authorized bodies (expert organizations) in the field of drug circulation in all EAEU countries.
The procedure as a whole has been simplified, and for some documents a deferment has been introduced for their submission.
In particular, based on the results of updating one of the registration procedures of the EAEU common market of medicines: the procedure for bringing Marketing Authorization Applications in compliance with the EAEU requirements:
the possibility of issuing perpetual marketing authorization certificates for medicinal products registered for more than five years in the reference state has been expanded;
making amendments to the Marketing Authorization Applications simultaneously with the procedure for its consideration in recognition states is allowed, which will speed up the updating of the marketing authorization application by the manufacturer and reduce its costs of launching a parallel procedure for making changes;
the list of documents that is provided as part of the Marketing Authorization Application for the harmonization procedure has been optimized by eliminating a number of duplicate or complementary documents; the authorized body has been given the opportunity to consider some of the documents in the post-registration mode without compromising the assessment of the quality, safety and effectiveness of the medicinal product;
additional safety measures for using medicinal products have been established, which can be introduced at the request of the authorized authority.
Work to bring Marketing Authorization Applications into compliance with the EAEU requirements accounts for about 60% of all registration work according to the EAEU rules. It is expected that the changes will accelerate the transition of manufacturers from the national to the union segment of the market and will have a positive impact on expanding the range of medicines circulating in the EAEU Member States.
For reference
Marketing Authorization Applications registered under the laws of the EAEU Member States must be brought into compliance with the EAEU requirements by December 31, 2025.
The simplified procedure for bringing Marketing Authorization Applications into compliance is stipulated by Decision No. 114 of the EEC Council dated October 20, 2023 “On Amendments to the Rules for Marketing Authorization and Expert Examination of Medicinal Products for Human Use.” The reduction of its enactment period, taking into account manufacturers' demand for the procedure is stipulated by Decision No. 142 of the Commission's Council dated November 24, 2023.
