The Federal Service for Supervision in the Sphere of Healthcare (Roszdravnadzor) informs about the decision of the Ministry of Health of Russia to suspend the use of a range of medicinal products.
The decision was made based on the conclusion of Roszdravnadzor in accordance with the Order of the Ministry of Health of Russia No. 777n of November 14, 2018 “On Approval of the Procedure for Suspension of Use of Medicinal Products”.
According to the information provided, the decision was taken in view of the MAH’s failure to submit to Roszdravnadzor Periodic Safety Updated Reports on the specified medicinal products, reports on adverse reactions (in accordance with paragraph 3 of Article 64 of the Federal Law of 12.04.2010 No.87-FZ “On Circulation of Medicines”), as well as the master file of the pharmacovigilance system (in accordance with paragraph 3.6 of the Rules of Good Pharmacovigilance of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Community of November 03, 2016 No.87).
The Federal Service for Supervision in the Sphere of Healthcare draws attention to the fact that in accordance to the Procedure for Suspension of the Use of a Medicinal Products approved by the Order of the Ministry of Health of Russia No. 777n of November 14, 2018 if the MAH fails to perform or improperly perform the duties set out in Clauses 3 and 4 of Article 64 of Federal Law No. 61-FZ it will be considered to be the basis for the suspension of the use of drugs.
As well as in case of any information on undesirable reactions not specified in the patient information leaflet is obtained during use of the medicinal product, serious undesirable reactions, interactions with other medicinal products that may pose a threat to the life or health of a person or animal or inconsistency of data on the efficacy and safety of the medicinal product with data contained in the patient information leaflet.