The first meeting of the Expert Committee for Medicinal Products at the Eurasian Economic Commission, chaired by Viktor Nazarenko, EEC Minister in charge of Technical Regulation, has considered mechanisms for resolving disputes arising during the registration of pharmaceuticals. Discrepancies in the benefit-risk assessment in expert reports of the reference State and the recognizing States for two master files have been discussed.
The Expert Committee has endorsed the Commission's initiative on the Eurasian Economic Union's Pharmacopoeia. It is expected that medicinal product manufacturers that previously received marketing authorizations according to the Union's rules will have to switch to the Eurasian Economic Union's Pharmacopoeia until January 1, 2026.
The draft amendments to Decision No. 93 of the Commission's Council dated November 3, 2016 were approved as well to extend the deadlines for recognizing the Union countries' GMP and the Union’s GMP for submitting these documents during national re-registration and making amendments to the pharmaceutical's master file until the end of 2025. The document contemplates mutual recognition of the Union's GMP certificates for foreign manufacturers by the EAEU countries' authorized authorities when implementing national procedures related to amending master files until December 31, 2025.
The proposed decisions will allow the Union countries’ pharmaceutical enterprises and foreign pharmaceutical manufacturers to implement procedures supporting the medicines circulation in national markets until the end of 2025, reduce production costs associated with their repeated inspection by each of the EAEU countries, ensure that pharmaceuticals are available to the population at any time and provide manufacturers with optimal conditions for transiting to the Union market.
The Council of Heads of Authorized Bodies in the Field of Sanitary and Epidemiological Welfare of the Union has considered prospects for resuming international transportation in the EAEU countries as well as anti-epidemic aspects of preparations for the Eurasian Intergovernmental Council's meeting in Minsk.
The meeting attendees have noted that the Commission, involving the Member States, plans to elaborate recommendations on determining approaches to resuming international transportation between the Member States. The possibility of resuming international transportation will be determined depending on the epidemiological situation in the Union countries.
Since the Eurasian Intergovernmental Council’s meeting may be held in Minsk on July 17 this year in a face-to-face format, the sanitary and epidemiological service of the Republic of Belarus is making some arrangements to prevent spreading the COVID-19 coronavirus infection. Mutual recognition of documents on compliance with preventive measures elaborated by the Union countries' security services will be provided.
The meeting has also discussed a comprehensive action plan in the field of public health and sanitary and epidemiological welfare to prevent spreading the coronavirus infection and other infectious diseases in the Union countries. The document is scheduled to be considered at the EEC Council’s meeting on July 10 and the EIC meeting on July 17 this year.
The Council of Heads of Authorized Bodies in the Field of Sanitary and Epidemiological Welfare of the Population of the EAEU Member States was established in accordance with Decision No. 9 of the Supreme Eurasian Economic Council dated May 31, 2016.
Following the meeting of the EEC Board held on June 30, it was decided to notify Russia of the need to enforce the Eurasian Economic Union's law. The Board qualifies the Rosselkhoznadzor's actions on prohibiting the supply of beef manufactured by some Belarusian enterprises to Russia and its movement through the country’s territory to the Union Member States as a barrier in the EAEU internal market.
The monitoring has revealed that the Belarusian beef deliveries to Russia had been suspended by the Rosselkhoznadzor since the end of 2019.
According to the Union's law, any regulated goods moved by all modes of transport within the EAEU customs territory shall be subject to veterinary control by a Member State's authorized authorities during their manufacturing and loading.
The meeting of the Eurasian Economic Commission’s Board held on June 30 adopted a disposition on forming a working group to draft proposals for establishing the Eurasian Economic Union Development and Support Institution. The working group will be headed by Sergei Glazyev, EEC Minister in charge of Integration and Macroeconomics.
The Kyrgyz Republic had previously spoken about the need to establish the EAEU Development and Support Institution. Having considered the initiative, the EEC Council instructed to form a working group from representatives of the Union States' public authorities and authorized organizations.
"The expansion of tools and mechanisms for financing economic development within existing regional financial institutions is expected to be discussed at the working group meetings," Toty Kaliaskarova, Director of Macroeconomic Policy Department, mentioned presenting the issue at the meeting of the Commission's Board.
It is planned to report on the elaborated proposals at the EEC Council's meeting.
A working meeting between Mikhail Myasnikovich, Chairman of the EEC Board, Serik Zhumangarin and Gegham Vardanyan, Members of the Commission's Board – Ministers, and Denis Manturov, Minister of Industry and Trade of the Russian Federation, was held via videoconferencing at the initiative of the Eurasian Economic Commission.
Issues related to ensuring access of the EAEU countries' industrial products to public (municipal) procurement of the Russian Federation were discussed in view of adopting Government Resolution No. 616 dated April 30, 2020 "On establishing a ban on access of industrial goods originating from foreign States to procurement for public and municipal needs as well as industrial goods originating from foreign States, works (services) performed (rendered) by foreign persons to procurement for national defense and state security needs”.
"There are appeals made by state authorities of Belarus and Kazakhstan as well as a whole range of ministries on this issue. There are a lot of appeals made by business entities as well,"Mikhail Myasnikovich emphasized. "The sides are concerned that applying Resolution No. 616 in the Russian Federation will lead to a new trade barrier."
According to the sides, refusals to participate in public and municipal procurement in the territory of the Russian Federation have already been recorded. And representatives of a number of Union States and the EEC believe that the arisen situation needs to be changed.
It was decided to consider possible options for resolving problematic issues during consultations with the EAEU States' representatives on July 2. This is required for removing possible obstacles in the Union’s single market and ensuring access of the Union countries’ economic entities to public procurement of the Russian Federation.