ARPM: implementation of the order “odd man out” will help to establish a single rule of state purchases

A Government Resolution № 1289 on “Limitations and regulations of admission to state purchases of foreign medicines that are included in the List of Essential Medicines” was taken into action on December 2015. According to the order, in order for the medicine to get state preferences in public trades the producer has to prove that the product was produced in Russia by presenting the CT-1 certificate that is issued by Chambers of Commerce in Russian regions.

    However, the first trades that were hold with accordance to the new rules showed that the order is being implemented not the same in different regions. Due to different interpretations of the order, ARPM called a meeting with all interested parties including The Ministry of Trade, Federal Antimonopoly Service, The Russian Chamber of Commerce in order to clarify and standardize the procedure of the CT-1 certification.

The certificate of origin of a medicine CT-1 is given to those medicines that are included in the list of the Essential Drugs and that are produced within the Eurasian Economic Union (EAEU).

    The status  “made in Russia” is given based on the criteria of the origin if the good that were established in the CIS Agreement on November 20, 2009. For foreign medicines that are primarily or secondary packed in Russia, the status would be effective until January 1, 2017. The certificate of the origin is given for the period of 6 months based in the Annual act of testing, or it could be granted for the period of a particular trade. Participants of the meeting noted that the certificate is presented after a customer applies for the purchase. However, the certificates are not required to participate in trades. Also, if a trading lot consists of a mixed (Russian/foreign) medicine, then the trade is зуащкьув based on the general rules of Federal Law 44.

    “Unfortunately the absence of the transition period before the new order created confusion on the market. The needed clarifications on the new legislation will be sent to the agencies that hold trades in the regions and the new system will allow for the local products to regain their positions on the market,” said ARPM Director General, Victor Dmitriev.

    A number of amendments to order 93 of the Chamber of Commerce were proposed during the meeting. Those amendments aim to eliminate some barriers that prevent companies get CT-1 certificate. The mandates are to be submitted to the Chamber of Commerce, Ministry of Trade, Ministry of Economic Development, and the Federal Antimonopoly Service.

    According to the final decision, the Association of the Russian Pharmaceutical Manufacturers began the process of  monitoring of CT-1 licensing in the regions and prepared for quick responses in case of undue delays. Therefore, the Association asks all interested parties to send them their concerns regarding CT-1 licensing.

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