The Union of Drug Manufacturers and Importers of Armenia: the unified drug market of the EAES has become an additional burden for the local producer

ArmInfo. Formation of the single market of medicines of EEUdid not improve the situation with exports for Armenian manufacturers of medicines. On the contrary, it created artificial barriers to the free circulation of more than 450 names of Armenian medicines in the markets of the EEUcountries. This was stated by the head of the Union of Drug Manufacturers and Importers of Armenia Samvel Zakaryan on September 19 at a press conference.

The functioning of the unified drug market of the EEU,  in his words, is almost complete. Meanwhile, for today the existence of numerous tasks, external contradictions in the legislative field do not allow the market participants to operate sufficiently freely and coordinated, as was originally stated.  The number one problem, as explained by the expert, is that the Russian side for the

registration in the territory of the Russian Federation, requires to undergo clinical studies of medicines that have been produced in Armenia for decades and have been registered in the republic. "This is quite expensive, and is a serious barrier to the export of local products, which is by no means a novice in the market and already has a sustainable reputation," concluded Samvel Zakaryan, head of the Union of Drug Manufacturers and Importers of Armenia.

Recall that on May 6, 2017 came into force a package of 26 documents of the Council and the Board of the EEU aimed at creating a single Eurasian market for medicines. Producers of Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan will be able to apply for registration of drugs and issuing them in circulation on a single procedure, thereby reducing administrative costs. According to the EEU report, development, preclinical and clinical study, quality control, registration, production and distribution of drugs will be carried out on supranational standards of the single market. At the level of national regulation, the issues of administering permitting for pre-clinical and clinical drug research are left; pricing of medicines and medical products; retail; public procurement of medicines and other procedures related to issues of cost recovery in the field of drug treatment; regulation of medical advertising. There is a transitional period from national to uniform regulation. In particular, until December 31, 2020, the manufacturer has the right to choose by which rules (national or uniform) he will register medicines. According to the agreement on the establishment of the Unified Energy System, the general pharmaceutical market should have been made since the beginning of 2016, but its launch was postponed due to the disagreements of the member states on the registration of medicines.