draft Resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Procedure for the State Registration (Reregistration) of Medicines” 

Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT); Harmonization (TBT)

medicines

Link to ePing

11.120 - Pharmaceutics

Human health

the draft Resolution of the Cabinet Ministers of Ukraine aims to align the Procedure for the State Registration (Reregistration) of Medicines, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 376 of 26 May 2005 (as amended by the Resolution of the Cabinet of Ministers of Ukraine of 26 April 2024 No. 529), notified in document G/TBT/N/UKR/300, with the provisions of the Law of Ukraine No. 3910 "On Amendments to the Law of Ukraine "On Medicinal Products" on Labelling of Medicinal Products" of 21 August 2024, notified in document G/TBT/N/UKR/307.The amendments to the Procedure for the State Registration (Reregistration) of Medicines provide for the regulation of the peculiarities of state registration of medicines that are not registered at the time of the procurement procedure after determining the winner of the procurement procedure  by verifying the authenticity of registration materials, as well as improving the procedure for making decisions on suspension, cancellation and termination of the state registration of medicines and decisions to refuse state registration of medicines.This draft Resolution intends to ensure consistency in national legislation on the labeling of medicines with the requirements of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

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