The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Speech at the V All-Russian Congress: “Pharmaceutical activity in Russia and EAEU: legal regulation 2017”

On December 13-14, 2017 in Moscow the V All-Russian Congress “Pharmaceutical activity in Russia and EAEU: legal regulation 2017” is taking place. The congress program focuses on the regulation of pharmaceutical activity in Russia and on the EAEU territory, as well as control and supervision in the sphere of medicines circulation and protection of intellectual property.

The key Congress topics are:

  • Innovations in the state registration of medicines and pharmaceutical substances in 2017-2018. Registration documents: the procedure for conformity building with the EAEU rules.
  • State regulation of medicines prices: problems of pricing, effectiveness of control and supervision for the application of medicines prices included in ZHNVLP.
  • New requirements for pre-clinical and clinical trials. Topical issues of pharmacovigilance in Russia and the EAEU.
  • Inspection on compliance with GMP standards: harmonization of requirements within the framework of the EAEU.
  • Latest changes in the field of medicines supply and interchangeability development.
  • Key trends in the development of law enforcement practice of public procurement of medicines in 2017. Risks and forecasts for the short-term period.
  • Protection of intellectual property rights in the pharmaceutical market. Exclusivity and confidentiality of registration dossier data.
  • Antimonopoly regulation of the pharmaceutical market in Russia and the EAEU.
  • Import of medicines and pharmaceutical substances into the Russian Federation: national and EAEU regulation. Parallel import: risks and opportunities for the legislative initiative.
  • Labeling of medicines: results and perspective for 2018.

On the first day, December 13, within the framework of the Conference “Registration and circulation of medicines in Russia and on the territory of the EAEU”, Natalia Novichkova, Head of the Expertise Department of FSI “SID and GP”, had the presentation, in which she spoke about sites preparation for inspection, analytical data on the number of issued certificates and refusals, and also shared information on the main non-compliances revealed during inspections.

 


Novichkova N. – Preparation for the inspection. Problems and possible solutions