Draft Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Procedure for State Registration (Reregistration) of Medicines” 

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

Medicines

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30 - PHARMACEUTICAL PRODUCTS

11.120 - Pharmaceutics

Human health

The draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Procedure for State Registration (Reregistration) of Medicines" has been developed to establish a unified mechanism for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products. _x000D_ The draft Resolution proposes to approve a new Procedure for the State Registration (Reregistration) of Medicines, which provides for:_x000D_ - the procedure for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products, and medicinal products under obligations;_x000D_ - the mechanism for amending the registration dossier materials;_x000D_ - the procedure for making decisions on suspension, cancellation and termination of state registration of a medicine and decisions to refuse state registration of a medicine;_x000D_ - the procedure for evaluating periodically updated safety reports on medicines and making appropriate decisions;_x000D_ - the amount of fees for state registration (reregistration) of medicines and the cost of services for the evaluation of registration dossier materials.

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