The Ministry of Health has submitted for public discussion a draft order regulating the procedure and terms for the publication on the official website of the Ministry of Health of the Russian Federation of information relating to the registration of medicines.

Data will be placed on the website no later than five working days after the Ministry of Health has received the documents.

The Ministry of Health plans to approve the procedure and time limits for the publication on the Ministry’s website of information relating to the State registration of medicinal products. The relevant draft order was at the stage of public discussion and has been published on the website: regulation.gov.ru/p/147371.

The document states that the Ministry must post information on the official website no later than five working days from the date of:

  • receipt by the Ministry of Health of an application for state registration of the drug;
  • receipt by the Ministry of Health of a conclusion based on the results of an expert examination of the registration dossier for the drug to determine the interchangeability of drugs;
  • receipt by the Ministry of Health of a conclusion based on the results of the expert examination of documents on the possibility to consider the drug as an orphan drug;
  • the Ministry of Health adopting a decision on state registration of the drug;
  • the Ministry of Health decides to exclude the drug from the state register of medicinal products.

The document should replace Order No. 747n of the Ministry of Healthcare and Social Development of the Russian Federation dated 26.08.2010.