Registration of medicines under national regulations extended till 2027
The Eurasian Economic Commission has decided to extend the validity of national drug registration rules in the EAEU countries, including Kazakhstan, until December 31, 2027, El.kz reports citing the Kazakh Ministry of Health.
Pharmaceutical companies from the member states of the Eurasian Economic Union will now be able to submit applications for the registration of new drugs under internal, national procedures for almost three more years. This also applies to changes in previously registered medications — they can be made according to the previous order without transitioning to the unified EAEU standards.
The decision made is related to the necessity to avoid disruptions in the supply of medications and a shortage in the market. According to experts, the extension of deadlines will ensure uninterrupted supply of vital drugs to the population, especially in light of the increasing demand for medications and changes in logistics chains.The changes were approved in the form of amendments to the previously adopted Decision of the EEU Council dated June 10, 2022, No. 96.
The new regulations is set to come into force on May 24, 2025, but will apply to all legal relations arising from January 1, 2025.
Thus, Kazakhstan and other countries of the union gain additional time to adapt their national pharmaceutical systems to the requirements of the EAEU, without risking the availability of medicines.
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