主题：【资料】俄罗斯注册文件

俄罗斯注册文件

A.  General Recommendations

1.  The set of documents and information shall be submitted containing the trade name of the medicinal product, INN, dosage form, dosage, applicant’s organization; without filing (the documents for the registration of medicinal products are submitted in ‘Crown’ type folders).

2.  The documents and information for the state registration of medicinal product (for introducing the modifications) shall be submitted in Russian or shall have the attested Russian translation.

3.  The order of the enclosed documents shall be in accordance with the provided list with the separation according to the items highlighted bold.

4.  The application for registration of the medicinal product to Roszdravnadzor (for introducing the modifications) in electronic format is submitted in Excel.

5.  The dossier is submitted on electronic and paper carriers in 2 copies:  a check copy and one for the organization in order to hold the expertise (enclosing 3 drafts of regulatory documentation, 3 drafts of the medical application instructions, and 3 sets of labeling samples).

6.  To introduce modifications that do not require the expertise the dossier is submitted in one copy (enclosing 3 drafts of the requested modifications of the regulatory documentation, 3 medical application instructions and 2 sets of labeling samples).


俄罗斯注册文件