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Changes to the rules of authorization and expertise of medicinal products for medical use
The working group members (Minutes No.74 dated October 5-7, 2020) have considered the proposals of five associations of the Republic of Kazakhstan, National Chamber of Entrepreneurs of the Republic of Kazakhstan ATAMEKEN and three associations of the Kyrgyz Republic on the extension of the transition period allowing for authorization of the medicinal products in compliance with the national legislation of the Union Member State.
Based on the results of the discussion and considering that the participants face many unsettled issues, low capacity of the EAEU integrated information system, the necessity of further improvement of IT processes and IT system reequipment, as well as due to the current epidemiologic situation the decision on extension of the deadline for 2 years has been taken, correspondingly, up to December 31, 2022, the applicant has the right to choose either a national authorization procedure or the procedure under the regulations of the EAEU.
At the same time, manufacturers and authorized bodies of the Union Member States shall be required to prepare a roadmap for the measures to b e implemented within the transitional 2 years. It is also proposed to develop the criteria for the selection of certain groups of medicinal products (iodine, water for injections, etc.), in respect of which it is inappropriate to bring the dossier in line with the EAEU regulations, but it is reasonable to transfer such products to the supranational register.
In the RF practice, when the registration dossier is brought into compliance, the authorized body refuses to accept updated models of packages, NDs for quality, SmPCs, IMU(DS) submitted according to the requirements of the EAEU, referring to the provisions of paragraphs 171 and 178 of the Rules.
Based on the above, for the purposes of uniform enforcement, the WG members agreed on the amendments and additions to paragraph 171.
Based on the results of the discussion, when bringing the registration dossier in compliance with the requirements of the Union in terms of compliance with the acts of the Commission, changes in draft packaging models, SmPCs, IMUs (DS) and ND for the quality of the medicinal product shall not be considered as the changes requiring re-assessment of the risk/benefit ratio and shall not be the changes affecting the correspondence of the registration dossier data as regards their content to the data of the registration dossier of the approved medicinal product.
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