The Registration Of Medicines Under The National Procedure Has Been Prolonged Until July 1, 2021

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A webinar on "Registration of medicines under the EAEU: the new reality. Challenges and prospects" with participation of Legalmax experts was held. The trend and development of the EEU pharmaceutical market...
Kazakhstan Food, Drugs, Healthcare, Life Sciences
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A webinar on "Registration of medicines under the EAEU: the new reality. Challenges and prospects" with participation of Legalmax experts was held. The trend and development of the EEU pharmaceutical market and market authorization file issues were discussed.

By the decision of the Council of the Eurasian Economic Commission dated by December 23, 2020 the application of procedure for registering new medicines under the national procedure in the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan and the Kyrgyz Republic was extended.

The national procedure will remain in the union states until June 30, 2021. With expiration of transition period, pharmaceuticals that do not have valid market authorization certificates of the Member States of the Union will be registered only in accordance with the Rules for the registration and examination of medicinal products for medical use of EAEU.

Procedures for changes, confirming and extending market authorizations and extending the validity of urgent market authorization accordance with the legislation of the EAEU states are available for pharmaceuticals registered in the countries of the Union before December 31, 2025.

Market authorizations issued under the national procedure are valid until expiration date, but no later than December 31, 2025.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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