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СТ-1 Certificates: at Special Focus

At the Fourth Partnering in Kazan “Russian Drugs – on the Way to Interdisciplinary Dialogue”, which is held annually by FAS RF, the Ministry of Healthcare of the Republic of Tatarstan and Association of Russian Pharmaceutical Manufacturers, the questions of issuing CT-1 certificates and amendments in public regulation is one of the key issues on agenda.

Partnering included manufacturers of drugs, representatives of authorities, accounts and executive authorities of Russian regions, who are active members of the pharmaceutical market. Particular attention was paid to pharmaceutical supply in the face of statutory amendments this year.

Timophey Nizhegorodtsev, Head of Social Sphere and Trade Administration, RF FAS, told about t he project of roadmap on pharmaceutical supply of population, discussed at the Russian Government. Talking about increased share of local products in public purchase, as a strategic goal of the state, Adel Vafin, Minister of Health of the Republic of Tatarstan, stressed, that it is possible to implement it only through joint efforts of manufacturers and authorities. It was reported, that lately, from 2014 to 2016, the share of locally manufactured drugs in the full range of drugs, purchased within FZ-44, increased twice, from 33% to 72%.

The presentation of Timophey Nizhegorodtsev on key proposals of the Administration on improving the system of pharmaceutical coverage, the need to establish interchangeability as “the sole way to reduce prices for drugs” was stress. The speaker set an example of EEU countries, where players at the pharma market make the list of interchangeable drugs . Talking about pricing, Timophey Nizhegorodtsev remarked, that FAS suggests that some manufacturers use an opportunity to revalidate prices for drugs. Talking about the proposed change of the principle of work on making a list of VED, the Head of Social Sphere and Trade Administration, RF FAS noted, that the commission should be working on a continuous basis, considering not more than 5 drugs per one meeting, which would enable a more detailed discussion of each point in the list. Nizhegorodtsev stressed, that the manufacturers should participate in the work of the commission, which is currently operating behind the closed doors.

The problem of issue and use of certificate on the country of origin of the product CT-1 within the resolution 1289 (“Odd one out”) was a matter of numerous vigorous discussions. Manufacturers were most eager to have information about the duration of validity of certificates issued for the drugs, which are only packed in RF. Today such products are covered by certificates. But it will only continue to the end of this year. Appropriate clarifications have already been sent to CCI.

Victor Dmitriev, General Director of ARPM told about the changes in the resolutions, regulating the issue of certificates,  facilitating and accelerating the process. Sergey Rodionov, Head of Methodological Department for Certification and Expert Activity , CCI RF, and Anatoliy Mayantsev, Head of Foreign Economic Activity Legal Support Department, CCI RF, gave clarifications as to the term of validity of certificates, their verification, terms of use, procedure of inspection and conclusion.

Anatoliy Mayantsev told about other innovations related to CT-1. Victor Dmitriev, General Manager of ARPM suggested that a request to CCI should be made to make the list of all issued certificates publicly accessible, so that manufacturers would be able to provide reference to the list instead of presenting the certificate, when submitting a bid for tender.

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