Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic use; immune serums, other blood fractions and immunological products, modified or unmodified, including those obtained by biotechnology; vaccines, toxins, cultures of microorganisms (except yeast) and similar products; immune sera, other blood fractions and immunological products, modified or unmodified, including those obtained by biotechnology; Medicinal products consisting of a mixture of two or more components for therapeutic or prophylactic use, but not packaged in dosage forms or in forms or packages for retail sale; Medicinal products consisting of mixed or unmixed products for therapeutic or prophylactic use, packaged in the form of dosage forms (including medicinal products.

Draft amendment to decision № 93 of the Council of the Eurasian economic Commission of 3 November 2016. (2 page(s), in English)

The Draft amendment to decision No. 93 of the Council of the Eurasian economic Commission of 3 November 2016 applies to the claimed for registration in the territory of the member States of the Eurasian economic Union drugs during the transition period and establishes the possibility, until 31 December 2020 submission of applicants for state registration, re-registration, confirmation of registration, amendments to registration dossier of medicinal products in accordance with the legislation of a member state of the Eurasian economic Union, documents issued by the authorized bodies of the member States confirming the compliance of the production of medicines with the requirements of good manufacturing practice of the Eurasian economic Union, or for medicines produced in the member States, documents issued by the authorized bodies of the member States confirming the compliance of the production of medicines with the requirements of good manufacturing practice of the member States.

Until December 31, 2025, it is established that applicants can submit documents issued by the authorized bodies of the member States confirming the compliance of the production of medicines with the requirements of good manufacturing practice of the Eurasian economic Union, or for medicines produced in the member States, when re-registering, confirming registration, amending the registration dossier of medicines in accordance with the legislation of the member States, requirements of good manufacturing practices of member States.

The draft amendment has been prepared in order to:

-           protection of life and health of the patient (as the final consumer of medicines); 

-           protection of the interests of drug manufacturers by reducing the costs of manufacturers associated with repeated inspections for compliance with the requirements of good manufacturing practices of the Eurasian economic Union.