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Definitions to be agreed upon

To avoid confusion, related to incompliances of wordings in the current legislation and practice of retail prices for VEDs, and with the purpose of control over implementation of the requirements on compliance of the pricing, FAS prepared amendments to 61-FZ

In particular, it is suggested to replace the words “for medical use” with “included into the list of vital and essential drugs” in Clause 60.

It is also suggested to replace words “vital and essential drugs” in item 10 with “drugs included into the list of vital and essential drugs”;

It is suggested to word items 2-8 as follows:

«2) approval of the method of calculation of maximum sale prices for holders or owners of marketing authorization certificates for drugs, included into the vital and essential drugs list, and introduction of mechanisms of forming a system of reference prices;

3) marketing authorization of the maximum sale prices for drugs;

4) maintaining a public register of maximum sale prices for holders or owners of marketing authorization certificates for drugs, included into the list of vital and essential drugs;

5) approval by executive authorities of constituent entities of the Russian Federation of a method of establishment of maximum wholesale margins and maximum retail margins to actual prices for drugs included into the lists of vital and essential drugs;

7) approval of the procedure of issue of instructions to executive authorities of constituent entities of the Russian Federation on adjustment with the legislation of the Russian Federation of solutions on setting the maximum wholesale margins and the maximum retail margins to actual retail prices for drugs, if these are taken in violation of the legislation of the Russian Federation in the order set by the Government of the Russian Federation;

8) Assignments to the authorized federal executive authorities of constituent entities of the Russian Federation on bringing into compliance with the legislation of the Russian Federation of solutions on setting maximum wholesale margins and the maximum retail margins to actual retail prices for drugs”.

These amendments will help avoid legal collisions and conceptual inconsistencies, which will help improve control over the vital and essential drugs.

The full text of the document is available at the Federal website of drafts of regulatory and legal acts.

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