Medicines

Draft Order of the Ministry of Health of Ukraine "On Approval of the Medicines Quality Certification Procedure for International Trade and Confirmation for Exported Active Pharmaceutical Ingredients"; (30 page(s), in Ukrainian)

The draft Order proposes to establish the legal and organizational framework for the procedure of quality certification of medicines for international trade and confirmation of active pharmaceutical ingredients intended for export through the updating of terminology and aligning it with the Law No. 2469-IX "On Medicines" of 28 July 2022.

The Order of the Ministry of Health of Ukraine of 25 July 2022 No. 1310 "On Approval of the Medicines Quality Certification Procedure for International Trade and Confirmation for Exported Active Pharmaceutical Ingredients" (notified in documents G/TBT/N/UKR/216 and G/TBT/N/UKR/216/Add.1) shall be repealed. The draft Order also establishes that any procedure for quality certification of medicines for international trade and confirmation of active pharmaceutical ingredients intended for export, which has been initiated but not completed prior to the entry into force of this Order, shall be completed in accordance with the Procedure, approved by the Order of the Ministry of Health of 25 July 2022 No. 1310, which, for the purposes of completing such procedure, shall apply in the version effective as of the date of entry into force of this Order. Any decisions adopted following the completion of such procedure shall be issued in the forms approved by this Order.