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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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
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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
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At the beginning of April 2023, a letter was published on the website of Roszdravnadzor for healthcare professionals about new data on the safety of drugs with an international non-proprietary name (INN) – valproic acid. This letter is based on a notice from Sanofi Russia regarding a higher risk of developing neurodevelopmental disorders (NDPD), including autism spectrum disorders, in children
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In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination of supplies of the Ozempic drug to the Russian Federation. It should be noted that according to the current legislation of the Russian Federation, the holder of the registration certificate must notify Roszdravnadzor in advance (1 year in advance) of the termination of
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Regulatory affairs specialists often come across the concept of grace period. For an ordinary consumer who buys a particular drug, this phrase usually does not have any meaning. However, not only but grace period determines the “speed” of updating instructions and packaging materials on the market. Let’s imagine the situation when the manufacturer has discovered a new contraindication to the
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In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines for medical use in the event of inventory shortage or risk of inventory shortage of medicinal products (Orders No. 593, PP No. 440, Order No. 339n). On February 13, 2023, Order No. 724n “On Amendments to the Regulations on the Interdepartmental Commission
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