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Main  >  News  >  Changes are made to the Procedure for the formation of the registration dossier in Russia

Changes are made to the Procedure for the formation of the registration dossier in Russia

Approved the new order of the Ministry of Health of the Russian Federation dated February 26, 2019 No. 97n “On Amendments to Clause 3 of the Procedure for Forming a Registration Dossier for a Drug for Medical Use and the Requirements for Documents in Its Composition, approved by Order of the Ministry of Health of the Russian Federation dated July 12, 2017 409n”. The document was registered by the Ministry of Justice on March 28, 2019 No. 54202. The order was published on the portal publication.pravo.gov.ru.

In accordance with the document, subparagraph “a” of subparagraph 1 is amended as follows:

a) the name, address of the applicant and the manufacturer of the medicinal product for medical use, information about their registration as a taxpayer in the country of registration (for Russian legal entities - taxpayer identification number (TIN), for foreign legal entities - country of registration, name of the registering authority, registration number, taxpayer code in the country of registration (Incorporation) or its equivalent) and the address of the place of production of the medicinal product (in case of presence of How many participants in the process of its production must specify each participant in accordance with the ongoing production stage).

Until now, it was necessary to provide the name and address of the applicant and the manufacturer of the medicinal product for medical use and the address of the place where it was manufactured (if there are several participants in the production process, each participant must be indicated in accordance with the stage of production).

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