On 1 September 2024, a joint order of the Ministry of Industry and Trade No. 3554 and the Ministry of Health No. 406n dated 7 August 2024 (hereinafter referred to as the “Order”) entered into force, approving a new procedure for providing the Ministry of Industry and Trade with information on medicines necessary for the purposes of licensing their production and inspecting the subjects of their circulation for compliance the requirements of good manufacturing practice. The Order replaced the previously existing procedure for interdepartmental interaction between the Ministry of Health and the Ministry of Industry and Trade.
The list of information that can be provided to the Ministry of Industry and Trade is established by part 2.1 of article 45 of Federal Law No. 61-FZ dated 12 April 2010 “On the Circulation of Medicines” (hereinafter referred to as the “Law No. 61”). This list includes information in relation to:
- pharmaceutical substances included in the medicinal product:
production technology with a description of the stages of production and control methods at all stages of production;
description of the development of the production process;
description of the control of critical stages of production and intermediate products;
properties and structure of active substances;
characteristics of impurities, etc
- pharmaceutical substances included in the medicinal products and entered in the state register of medicines:
the name of the pharmaceutical substance, its structure, general properties;
manufacturer’s names and address;
the results of the analysis of pharmaceutical substance series;
expiration date
- the medicinal product:
requirements for the quality of excipients;
analytical techniques used in the implementation of quality control of excipients;
the list of standard samples used in the implementation of quality control of a medicinal product;
information on the stability of the medicinal product, etc
In order to receive necessary information, the Ministry of Industry and Trade should send a request to the Ministry of Health containing information about:
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the full name of the medicinal product’s manufacturer;
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the name of the medicinal product in accordance with the marketing authorization or state register of medicines;
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name and address of the medicinal product’s production site;
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details of the medicine’s marketing authorization (if available);
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a list of requested information with a reference to a specific item (list of items) of part 2.1 of article 45 of Law No. 61.
Within 2 business days from the date of receipt of the request, the Ministry of Health registers it and sends it for consideration to the Scientific Center for Expert Evaluation of Medicinal Products (hereinafter referred to as the “Center”). The Center within 3 business days sends to the Ministry of Health the information and documents required by the Ministry of Industry and Trade with their inventory attached. Then, within 2 days, the Ministry of Health sends these documents and information in writing to the Ministry of Industry and Trade. If the information sent contains information constituting a trade secret, the Ministry of Health sends a notification to the holder or owner of the marketing authorization for the medicinal product about their provision.