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The Guidelines stipulate requirements to be complied with by Russian pharmaceutical companies and the deadlines for transition to the subject standards. Particularly, the start of switching to GMP standards for the industry is planned already for this year. By 1 May 2011, pharmaceutical producers are supposed to comply with 2 sections of the Guidelines (requirements applicable to the pharmaceuticals products, personnel, premises and production quality control) and by 1 December 2011 – with 5 sections (including selecting the original materials and packages for clinical trials, manufacturing parameters, ensuring the drug series compliance for launching it into circulation).
If the Resolution is adopted, compliance with the subject GMP will be critical for retaining the pharmaceutical license. Non-compliant companies could be prohibited from selling the goods and be exposed to penalties of RUB 40 000 — 50 000 (USD 1 500 – 1 700) or even to suspending the activities for up to 90 days.
Pursuant to the negotiations with the European Union Commissioner for Healthcare, Mr. John Dalli, Mrs. Tatiana Golikova announced that Russia and the European Union are prepared for elaborating the treaty on mutual acknowledgement of clinical trials results.
As per Mrs. Golikova, European experts are aware of the innovations stipulated by the Russian Federal law “On pharmaceuticals circulation”. The parties also discussed harmonization of the hygienic standards – currently there are 350 corresponding items.
The Russian Ministry for Healthcare and Social Development and the Russian Patent Service (Rospatent) signed an agreement on collaboration with respect to legal protection of intellectual activities results and the means of individualization related to circulation of pharmaceutical products.
The agreement should ensure statutory protection of the rights of innovative and original pharmaceuticals developers’ and should establish efficient cooperation with respect to IP protection in pharmaceutical industry.
Mrs. Tatiana Golikova mentioned that the Ministry is supposed to provide Rospatent with the data on pharmaceuticals sold by companies in the Russian market, and Rospatent will, in its turn, inform the Ministry concerning the scope of rights for distributing these particular drugs.
The results of the separate accounting are supposed to be used by manufacturers to support the computation of maximum producers’ prices for essential drugs in course of their state registration.
The Agreement between the “Skolkovo” Fund and the Russian Ministry of Healthcare and Social Development is to be signed on 5th April by Mr. Igor Goryanin (the Executive Director for the cluster of biological and medical technologies) and Mrs. Veronika Skvortsova.
As per the Agreement, the priority areas for cooperation between the Ministry and Skolkovo are:
To ensure the regular interaction between the Fund and the Ministry, the special coordinating board (including representatives of both parties) is to be formed.
To increase the production of medical equipment within the country and to support local manufacturers, the Government has prepared the program "Development of medical and pharmaceutical industry”, according to which, it is planned to increase the share of the Russian medical equipment to 50% by year 2020.
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