At the end of June 2023, a letter from the Ministry of Health of the Russian Federation was published on the GRLS website containing recommendations for amending the documentation for healthcare professionals and patients. Diltiazem is used to treat stable angina and hypertension. The drug expands the coronary and peripheral arteries and arterioles, reduces the total peripheral vascular resistance, smooth
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In May 2023, Decision No. 60 “On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use” was published on the legal portal of the Eurasian Economic Union. By this decision were approved a number of important changes that many members of the regulatory community were waiting for. Firstly, as part of these changes, some terms
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From 03/01/2022, within the framework of Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On approval of the rules for state registration of medical devices”, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) began to post additional information on registered medical devices (MD), namely photographic images and instructions for use. To obtain this information,
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According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling of certain types of medical devices using identification means. This Decree establishes that the parties involved in the circulation of certain types of medical devices shall submit an application to the State Information System for
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The PharmComm company, the owner of the exclusive rights to the Bezornil® trademark, found pages of sellers on marketplaces that were not related to this product in any way. The cards of some products also featured the wording “better than bezornil”. After unsuccessful attempts to contact the management of the Wildberries marketplace, the company turned to the Moscow Office of
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In May 2023, a letter regarding the safety of proton pump inhibitor drugs containing omeprazole, pantoprazole, rabeprazole, lansoprazole, esomeprazole, dexlansoprazole as an active ingredient was published on the website of the State Drug Administration of the Ministry of Health of the Russian Federation. It turned out that drugs of this group can cause kidney disease. What are these active ingredients?
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At the end of May 2023, a letter from the Ministry of Health and the expert center of the Federal State Budgetary Institution ‘SCEEMP’ was published on the State Register of Medicines (GRLS) with clarifications for applicants on the availability of medicines sold without secondary packaging in circulation. What is secondary packaging? According to the information from the general pharmacopoeial
Read moreOn May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for the purposes of state registration. According to Order No. 201n, the applicant must notify Roszdravnadzor of the intention to import medical devices in the electronic form for the purposes of state registration. The notification procedure for the import of unregistered
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Regarding the national registration of medical devices in the Russian Federation, it is often clarified – is registration required in the country of origin or is a CE certificate, declaration, Free Sale certificate, export certificate and other such documents required? According to the current position of the Federal Service of Roszdravnadzor (the relevant reply to our request was received in
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The Unified Customs Register of Intellectual Property Objects of the Member States of the Eurasian Economic Union (hereinafter referred to as the Unified Register) was introduced into effect by Article 385 “The Unified Customs Register of Intellectual Property Objects of the Member States”[1] of Appendix No. 1 to the Treaty on the Customs Code of the Eurasian Economic Union of
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