Which variations to the registration dossier for drugs do not require expertise in 2023?
In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal product (MP). Thus, the changes have impact on grounds for making changes to the registration dossiers that do not require an examination of quality, efficacy and safety.
Now examination of MP will not be required in the following cases:
- exclusion of the manufacturer or supplier of any starting material, reagent, intermediate substance of the pharmaceutical substance that is part of the medicinal product;
- replacement (addition) of the manufacturer of the pharmaceutical substance, if it is included in the state register of medicines (GRLS);
- replacement (addition) of manufacturers (suppliers) of initial materials and excipients or the same materials;
- replacement (addition) of manufacturers (suppliers) of equipment or similar equipment and changes in production due to the use of alternative equipment;
- replacement (addition) of manufacturers (suppliers) of reference materials, reagents, materials and equipment used in analytical methods;
- replacement (addition) of manufacturers of the primary packaging of the pharmaceutical substance;
- replacement of ethyl alcohol used in the production of the pharmaceutical substance of ethanol.
In addition, an examination will not be required if the details (name, legal form, contacts) of the manufacturer of excipients are changed and one or more manufacturing sites for pharmaceutical substance are excluded.
The new order also affected section II of the variation classification, which includes changes that require an examination of the quality, efficacy and safety of the medicinal product. Variations, for which an examination is required with the provision of samples, were singled out in a separate list. In other cases, a documented assessment of the quality, efficacy and safety of the drug with the submitted adjustments is carried out.
- Order of the Ministry of Health of Russia dated 12/13/2016 N 959n (as amended on 03/06/2023) “On approval of the classification of changes made to the documents contained in the registration dossier for a registered medicinal product for medical use” (Registered in the Ministry of Justice of Russia on 01/09/2017 N 45123)