New Procedure of Drugs Sale Suspension in Russia

25 March 2019

GMP News

A new procedure for the suspension of the use and sales of drugs in the Russian market has been developed by the Russian Ministry of Health, which used the existing federal law “On the Circulation of Medicinal Products in Russia” during its design, according to an official spokesman of the Ministry, reports The Pharma Letter’s local correspondent.

In accordance with the new procedure, the main reason for the suspension of sales of a particular drug in the Russian market will be the receipt of information about its adverse reactions during treatment, as well as potentially harmful effects during its combination with other drugs.

The decision of the withdrawal of the drug from the market will be taken by the Russian pharmaceutical watchdog, the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor). The latter may also prohibit the use of the drug, if the results of clinical studies presented by the manufacturer during registration were to be recognized as unreliable. Another reason for the ban is if the composition and the technology of drug’s production do not match the data stated in the registration dossier.

At the same time, the new procedure also prescribes the procedure for resuming sales of the drug in the market. In accordance with this, a holder or the owner of the registration certificate of the banned drug may contact the Ministry of Health of Russia with a complaint that will be considered within 15 business days.




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