Inventory shortage or risk of inventory shortage – update of legislation. Part 2.
In the second part of the article on inventory shortage, we would like to pay more attention to registration aspects in the event of a inventory shortage.
In the event of a inventory shortage, the state registration of the medicinal product is carried out by the Ministry of Health of Russia within a period not exceeding 60 working days. Documents and information are presented in the form of electronic documents signed with an electronic signature.
The Ministry of Health of Russia, when performing state registration of a medicinal product, if necessary, establishes one or more of the following conditions:
a) introduction of restrictions on the use of the medicinal product for its safe use;
b) the obligation to conduct post-registration clinical trials, the results of which are the basis for assessing the ratio of the expected benefit to the possible risk of using the medicinal product when confirming its state registration;
c) requirements for drug labeling;
d) submission of reports of side effects, adverse reactions, serious adverse and unforeseen adverse reactions when using the medicinal product, the features of its interaction with other medicinal products, individual intolerance, as well as other facts and circumstances representing a threat to human life or health or affecting a change in the ratio of the expected benefit to the possible risk of the use of the medicinal product, identified at all stages of treatment to the Federal Service for Surveillance in Healthcare.
Grounds for rejection in state registration of a medicinal product:
a) non-submission of documents by the applicant, or their improper execution;
b) the applicant’s failure to provide a response to the request on time;
c) the absence of an opinion of the interdepartmental commission on the presence of a inventory shortage in relation to the medicinal product or the risk of its occurrence;
d) availability of the expert commission conclusion and (or) the ethics council conclusion on the impossibility of state registration of the medicinal product;
If it is necessary to make changes to the documents of the registration dossier for a medicinal product, a quality examination may be required (25 working days). If a quality assessment is not required, then the procedure for making changes takes 10 working days.
More information – email@example.com
- Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022
- Decree of the Government of the Russian Federation of 05.04.2022 N 593 “On the peculiarities of the circulation of medicinal products for medical use in the event of a inventory shortage or the risk of a inventory shortage in medicinal products in connection with the introduction of economic restrictive measures against the Russian Federation”
- Decree of the Government of the Russian Federation of March 23, 2022 N 440 “On approval of the specifics of making changes to the documents contained in the registration dossier for a registered medicinal product for medical use in the event of a inventory shortage or risk of a inventory shortage in medicinal products in connection with the introduction of restrictive economic measures against the Russian Federation character”