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Drug registration in EAEU

Drug examination and registration regulations has been accepted and approved for Eurasian Economic Union

Nov. 25th, 2016

Documents for registration of drugs, issued according to the law of the Member States of the EAEU, are considered fit until the end of their validity term, but not later than 31 December 2025.

Pharmaceutical products examination and registration regulations for medical use are approved by ECE Council Decision No. 78 as of November 3, 2016.

Regulations prescribe the procedure for the registration of durgs, proof of registration and re-registration, the introduction of new information in the registration dossier and other processes related to drug registration in accordance with the laws of the Member States of the Eurasian Economic Union to be used in medicine and not completed by the authorized bodies of the Member States of the Eurasian economic union before January 1, 2016.

Until December 31, 2020, the registration of pharmaceutical products upon the applicant's decision takes place in accordance with these Regulations or under the laws of a Member State.

Registered drugs according to the requirements of the legislation of a Member State, will be available for use within the boundaries of that particular Member State of the Eurasian Economic Union, where the authorized body has issued the registration certificate.

The validity of the document confirming drug registration and issued by the competent authorities of the Member States before 1 January, 2016 may be extended under the laws of the Member States, but not for a period exceeding 31 December, 2025. Any amendments to the drug registration information prepared in accordance with the standards of the Member States of the EAEC are possible up to 31 December, 2025.

Thus, the drugs that were timely registered under the laws of the Member States must meet the requirements of the international regulations and treaties that form the EAEC law up to December 31, 2025.

Documents for the registration of pharmaceutical products, prepared according to the law of the Member States of the EAEU, shall be deemed valid until the end of their validity term, but not later than 31 December, 2025.

The decision shall take effect after 10 calendar days from the date of activation of the Protocol, signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on common principles and rules of circulation of medicinal products within the Eurasian Economic Union dd. December 12, 2014, but not earlier than after 10 calendar days from the date of publication of this decision.

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