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The Ministry of Healthcare of the Russian Federation will be authorized to register medical drugs for sale in the EEU market

26.12.2016

The terms for the transfer of responsibility to the Ministry of Healthcare of the Russian Federation in association with the registration of medical drugs produced for the common EEU drug market are provided in the Decree "On Amendments to the Provision on the Ministry of Healthcare of the Russian Federation" published on the federal portal of regulatory legal acts.

It is implemented in compliance with the Regulations set forth by the decree. Furthermore, the Ministry of Healthcare of the Russian Federation is empowered to suspend or terminate the actions detailed in the document which are required for the correct registration of medical drugs, and also to restrict the use, development and formation of innovations to the rules of the medical drug registration certificate, according to the Regulations.

It should be noted that the pharmaceutical industry in each of the five territories constituting the Eurasian Economic Union started on equal terms, but later developed in different ways. Today they are developed on the same basis, but with some differences. Common approaches are being sought after in order to build a common drug market, with its participants requiring a lengthy 10-year transition period, the registration period requiring 5 years. After this time, the rules will become supranational.

The transfer of powers to the Ministry of Healthcare of the Russian Federation associated with other actions set by the Rules, and the acceptance of all necessary documents prepared on the basis of the Eurasian Economic Commission acts is also being discussed.

They shall perform the following functions:

1.    Approve the general parameters of medical drugs, guidelines for medical applications, type and parameters of the quality certificates, package layouts, and the approved risk management plan for medical drug use in the drug registration area, created for application in the EEU drug market.
2.    Cooperate with the authorized bodies of the EEU member countries for drug use and drug registration formed for the common EEU market by the Expert Committee for EEU medicinal products and other aspects of application within the boundaries set for the EEU.
3.    Cooperate with the federal executive bodies for the registration of medical drugs made for use in the common EEU drug market. Prepare the documents permitting the import of certain batches of non-registered medical drugs into the Russian Federation produced in order to undergo testing by experts to further the registration process of medicinal products intended for use in the common EEU drug market in compliance with the Rules of Expertise and Registration of Drugs for Medical Use.

Some settlement measures shall also be taken, including:

  1. The procedure for interaction with the federal executive bodies for the registration of medical drugs produced for sale in the EEU in cooperation with the Ministry of Industry and Trade of the Russian Federation and the Federal Service for Surveillance in Healthcare.
  2. The procedure for scientific and pre-registration consultation preparations and arrangement in compliance with the Rules provided for the documentation and expertise of medical drugs.

The launch of the common drug market will benefit all citizens and business groups of the Union member countries, because the pharmaceutical manufacturers of these countries will acquire a common step-by-step procedure based on general regulations, taking into account the most effective world practices. Such an approach allows domestically manufactured medicinal products to raise their reputation and competitive strength in the world market, while also removing the abundant trade obstacles inside the Union, thus minimizing manufacturer costs.

The dynamic development of the EEU regulatory base improves the quality of the drugs, makes them safer and more effective, and also removes the barriers predetermined by the specific features of the national pharmaceutical markets.

As a result, business opportunities and benefits for the population are created and the EEU priorities are defined. All decisions are approved following public discussions and thorough study of the consequences of each action. The Commission acts concerning the drug circulation are changed according to these measures.

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