By Decree No. 568 dated 03.05.2024 the Government of the Russian Federation amended Decree No. 1771 dated 31.10.2020 on peculiarities of regulation of maximum selling prices for vital and essential medicines at the risk of defectiveness.

Decree No. 600 of 15.05.2024 also amended the powers of the Ministry of Health enshrined in Decree No. 608 of 19.06.2012. This measure is necessary to minimize the risks of defective medicines associated, among other things, with the sudden withdrawal of foreign manufacturers of medicines from the Russian market. The listed amendments will come into force on 01.09.2024 .

According to the amendments, manufacturers will be able to increase prices for drugs at the risk of defectiveness on them only until September 1, 2030.

Also, the document adopted by the Government states that the conclusion on defectiveness or risk of its occurrence is valid for three months from the date of its signing. Previously, there was no such term. The formulas for the index of deviation of the entry of a medicinal product into civil circulation and the index of provision of the need for a medicinal product have been changed.

The economic analysis will not take into account prices for those drugs which are registered in Russia but have not been put into civil circulation within 24 months preceding the economic analysis.

The Federal Antimonopoly Service (FAS) will be able to cancel the effect of the increased price if the manufacturer has not put the declared volume of the drug into civil circulation within 12 months after re-registration of the price.

The period for requesting information on defects or the absence of drugs in circulation in connection with drug pricing may be extended by three working days under certain circumstances. The total period for the Ministry of Health to review documents and information has been reduced from 20 to 12 working days.

The Ministry of Health will also notify the applicant of the submission of documents to the FAS and of the antimonopoly authority’s decision. If the FAS requires additional documents from the manufacturer, the manufacturer will be able to submit them electronically.