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EAEU Single Market: In Search of Harmony

09/23/2019 | GMP conference, GMP certificate, EAEU

The panel discussion “The Single Market of the EAEU Countries: Challenges and Prospects for Interaction”, held on September 23 at the IV All-Russian GMP Conference, aroused great interest among the participants. The event raised a wide range of issues regarding the harmonization of the laws of the Member States and work within the framework of supranational legislation.

From January 1, 2021, registration of drugs and inspection of their production will have to be carried out using EAEU GMP certificates, so today it is necessary to carry out work aimed at achieving this goal.

Gelena Grosheva, Head of the Division for Licensing and Inspection of Drug Production of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, said that a working group is engaged in harmonizing the legislation in the Ministry. At present, the draft law on amendments to regulatory legal acts is almost ready and will be presented for discussion in the near future.

The experts noticed that an important point is the training of personnel ˗ of the future authorized persons in the field of managing the work of the pharmaceutical quality system. This topic was opened by Natalya Pyatigorskaya, Head of the Department of Industrial Pharmacy of the First Moscow State Medical University. THEM. Sechenova, member of the SEC in the field of pharmacy, Doctor of Philosophy, professor. She noted that professional competence, providing for the study of the full life cycle of drugs, is developing at Sechenovskiy University. At the moment, on the scale of the market, it is necessary to develop a procedure that will allow certification of authorized persons according to the rules of the EAEU.

The speakers also discussed issues such as regulating the sphere of circulation of drugs in the EAEU, harmonization of requirements and mutual recognition, the Pharmacopoeia of the Union and registration dossiers, especially the transition from national legislation to supranational.

The opinion was expressed by the head of the coordination of work in the field of circulation of medicines and medical devices of the Department of technical regulation and accreditation of the EEC Dmitry Rozhdestvensky, director of the Department of state regulation of the circulation of medicines of the Ministry of Health of Russia Philip Romanov, general director of the FSBI “NTsESMP” Russian Ministry of Health ., Yuri Olefir, and others.

Speakers from Belarus, Armenia, Kazakhstan and Kyrgyzstan took an important place in the discussion. Colleagues identified the difficult moments that they see for their part. For example, Mkrtich Shakaryan, head of the Good Pharmaceutical Practice Department of the CJSC “Emil Gabrielyan Scientific Center for Drugs and Medical Technologies Expertise” CJSC, emphasized that harmonization of rules and uniform approaches to the training of inspectors in the field of quality is the main task for today to future discrepancies did not lead to undermining trust and difficulties in the provision of medicines.

Speakers noted that in addition to the direct changes required by the creation of a single market, it is necessary to constantly improve the effectiveness of the quality system and improve pharmacovigilance.

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