Pharmaceutical manufacturers see the measures taken to support the business as ineffective

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The measures that the Government has taken to support the pharmaceutical industry do not seem effective. This is reported by FV with reference to market participants.

According to the publication, this concerns, in particular, the possibilities of drug registration under an accelerated procedure (Decree of the Government of the Russian Federation No. 593 of April 5, 2022),  a special procedure for making changes to the registration dossiers (Decree of the Government of the Russian Federation No. 440 of March 23, 2022) in case of a shortage of a drug or the risk of its occurrence due to the sanctions,  as well as the simplified procedure for VED prices re-registration (Decree of the Government of the Russian Federation No. 444 of March 23, 2022).

For almost a month, market participants did not have the technical opportunity to submit the necessary documents provided for by Resolution No. 593. VED prices re-registration procedure has to be completed within 30 working days. However, manufacturers are facing violations of that deadline.

According to market participants, in order to support the market, among other things, it is necessary to establish a simplified procedure for bringing the registration dossier into compliance with the EU rules and introduce changes in respect of drugs that are already registered, as well as to reduce state duties for these procedures.

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