Draft labeling of drugs has stalled due to the government’s observations

Meeting with Dvorkovich

The government has delayed the approval of methodological recommendations for the labelling of medicines, said a source in the pharmaceutical market. The developer of the document, the Federal service for supervision of health (Roszdravnadzor), the government has asked for a continuance because he had not coordinated the project with the relevant agencies, including the Ministry of Finance, Ministry of industry and trade and FTS.

In a press-service of the Ministry of Finance confirmed that the document was not approved because the authority has comments on the composition and structure of the information that you plan to encode in the label. In addition, the latest version of the recommendations does not allow you to participate in the experiment, a wide range of interested market participants, and its terminology needs improvement, said the officials.

The Ministry of industry and trade and the Federal tax service explained that agencies have comments on the recommendations. So, the comments of the Ministry of industry and trade relate to the inconsistency of the recommendations of the current Russian legislation.

The meeting, which discussed guidelines for the labelling of medicines was held on 8 February at the profile Deputy Prime Minister Arkady Dvorkovich, told his representative Aliya Samigullina. A preliminary version of the document Roszdravnadzor needs to post for public comment on its website next week, she said. “After reviewing the proposals, the recommendations will be approved. Expect [it will happen] until the end of the month,” said Samigullina. Recommendations planned to approve the 30 November 2016, the draft “road map” for the implementation of labelling in Russia, which the Ministry of health sent for approval to the government in the fall of 2016 (document not approved).

The experiment for the labeling of drugs with special control signs de jure was launched on 1 February 2017. Labelling of medicines needed to counter the trafficking of counterfeit and adulterated medications, it will allow us to verify the authenticity of medicines with a smartphone, noted the Prime Minister Dmitry Medvedev on January 30 Cabinet meeting. The label on all medicines traded in the Russian market, and this six billion packages per year, will cost the state and market 15 billion rubles was revealed in October 2016, the head of Roszdravnadzor Mikhail Murashko.

The experiment according to plan

Due to the lack of approved recommendations of the manufacturers can begin to label drugs, said the plant Manager, AstraZeneca (the experimental participant) Gennady Packi. While there are no requirements, the company does not know what equipment she needs to buy, he said.

Equipment one line will cost the pharmaceutical manufacturer from 30 thousand euros to several hundred thousand euros, calculated in Federal projects of JSC “Centrinform”. The cost of equipment depends on the characteristics of production, its volume, etc., said analyst Dmitry Baglay.

The experiment is in accordance with the schedule agreed in the press service of Roszdravnadzor. Development of recommendations is the preparatory period of the experiment, which runs until March 2017. The document was prepared in cooperation with the companies-participants of the experiment, so the manufacturers are familiar with its contents, emphasized in the service.

Pharmaceutical companies participating in the experiment for the labeling of drugs, actively participated in the development of guidelines, confirmed Deputy General Director of the pharmaceutical company STADA CIS Ivan Glushkov. Thus, STADA CIS has already purchased the equipment for marks some of their products. “The signed documents yet, but we know what it is the code, what it should be encrypted and where it should be,” — said Glushkov . According to him, the order and installation of equipment for the labeling of drugs can take from six months to a year, so purchasing it and setting care must be taken in advance.

Employees of AstraZeneca participated in the preparation of documents and saw their preliminary options, reported in a press-service of the company. However, questions to the project with the manufacturer still remains, said the representative of AstraZeneca. If in the final version of the recommendations requirements will differ significantly from the European one, the company will have to additionally order and buy the equipment, said Packy.