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About 200 recommendations on re-registration of medicines and amendments to registration materials – results of the Center's STC meeting.

11.12.2023 1681 review

Following the meeting of the Scientific and Technical Council of the Center of 07.12.2023 on the review of registration materials submitted for state expert evaluation for their registration/re-registration, amendment of registration materials, and materials on clinical trials of medicinal products in Ukraine, the Center provided the Ministry of Health of Ukraine with about 200 recommendations. Of these:

  • for re-registration of medicinal products – 5
  • to registration of substances – 1
  • to re-registration of substances – 2
  • amendments to registration materials for medicinal products (regarding quality, safety/efficacy and pharmacovigilance, administrative, etc.) – 177
  • amendments to the protocols of international multicentre clinical trials of medicinal products – 11.