The experts of FSI «SID & GP» took part in the VI International Forum «Anti-counterfeit 2018»
The representatives of the State Institute of Drugs and Good Practices of Minpromtorg of Russia took part in the International Forum «Anti-counterfeit 2018» held on 19-21 November, 2018 in Moscow.
This is the main expert discussion platform of the Eurasian Economic Union, where representatives of the society, state, and business discuss the issues of market protection against counterfeit and adulterated products, harmonization of regulations in standardization and certification, as well as protection of the rights of right holders commercializing the results of their intellectual activity.
As highlighted by the organizers of the event, the issues of fighting against illegal trafficking of industrial products is one of the most pressing global challenges, including the EAEU, both for economical reasons and for the reason of the need in ensuring safety of patients’ life and health. Illegal trafficking of industrial products has negative consequences as it results in business losses and severe losses of the state budget, while the products are hazardous for patients’ life and health.
The Head of Drug Manufacture Inspections Department of FSI «SID & GP» Ekaterina Nikiforova was a speaker in the session on the topic «International practices of ensuring drugs circulation legality (The issues of implementing the Convention of the Council of Europe on fighting adulterated medicinal products and similar crimes threatening public health within the EAEU territory). Decisions, global-level initiatives, practical approaches to fighting counterfeit medicinal products and protection of public health». In her report «The examples of identifying counterfeit drugs during inspections of foreign manufacturers», she presented the statistics of observed non-compliances with the requirements of the registration file, reminded Forum participants that Federal Law No. 61 as of 12 April, 2010 «On Drugs Circulation» provides such definitions as an adulterated, falsified and counterfeit drug, and talked with examples about the problems faced by Russian inspectors during inspections at foreign manufacturing sites.
«In certain cases, non-conformities with GMP requirements may result in suspension of drugs within the Russian Federation territory, which is also stipulated by legislation in Federal Law No. 140 «specify name» as of 15 June, 2018», said Ekaterina Nikiforova.
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets