Introduction of pharmaceutical substance to GRLS
Pharmaceutical substances (PhS) are not subject to state registration. In order to sell the substance on the territory of the Russian Federation, it must be included in the State Register of Medicines (GRLS – transliteration from Russian) (https://grls.rosminzdrav.ru/GRLS.aspx). Inclusion in GRLS is carried out on the results of quality examination.
1.What documents are needed?
– Documents confirming payment of government fees;
– A copy of the document confirming the production permit, or a copy of the conclusion on compliance with the rules of GMP issued by the Ministry of Industry and Trade;
– Technical document for the pharmaceutical substance;
– Information about the registration of the manufacturer in the country of origin;
– Application for a permit for the import of samples;
2.Procedure and terms.
Before submission of documents to the Ministry of Health of the Russian Federation for inclusion of substance in GRLS it may be necessary to obtain another document — permission for import of samples. The term of service is 5 working days.
To obtain an import permit, it is necessary to provide the following information to the Ministry of Health of the Russian Federation:
– Justification of the quantity of imported pharmaceutical substance; –
Certificate of quality PhS from the manufacturer;
Further, the application for inclusion of PhS in GRLS together with other documents is submitted to the Ministry of Health of the Russian Federation. Within 10 working days, the Ministry of Health of the Russian Federation checks the documents for completeness and accuracy and sends the task for the examination to the expert institution (FGBU “NCESMP” – http://www.regmed.ru/Default.aspx ).
The applicant must submit samples to the expert institution within 15 working days from the date of the assignment. Upon receipt of samples, the expert institution shall issue to the applicant a document confirming this fact.
The expert center reviews the documents and verifies the reproducibility of the quality control methods of the pharmaceutical substance within 60 working days.
Further, within 5 working days the Ministry of Health of the Russian Federation decides to include the substance in GRLS.
In case of a request from the Ministry of Health of the Russian Federation or the expert center, the applicant has 90 working days to provide additional information.
The fee for inclusion of pharmaceutical substance produced for sale in the GRLS is 145 000 rubles.
- Federal Law of 12.04.2010 N 61-FZ (ed. 27.12.2018) “On Circulation of Medicines”.
- The Tax Code of the Russian Federation Article 333.32.1. The amount of the state fee for the commission of actions by the authorized federal executive body in the implementation of the state registration of medicines and registration medicines for medical use in order to form a common market of medicines within the Eurasian Economic Union
- Order of the Ministry of Health of the Russian Federation of 02.08.2012 N 58н (ed. 07.10.2013) “On approval of the Administrative Regulations of the Ministry of Health of the Russian Federation on the provision of state services for the issuance of permits for the import into the territory of the Russian Federation of a specific batch of registered and/or unregistered medicines intended for clinical trials medicines, a specific batch of unregistered medicines intended for examination of medicines for the purpose of state registration medicines, a specific batch of unregistered medicines to provide medical care according to the life indications of a particular patient” (Registered in the Ministry of Justice of the Russian Federation 04.03.2013 N 27438)
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