On September 12, the Union of Consumers of Medical Services, Medicines and Medical Devices addressed the Minister of Health of Ukraine and the Chairman of the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance in connection with a public discussion of changes to the Procedure for Confirming the Compliance of the Production Conditions of Medicines with the Requirements Good Manufacturing Practices (GMP).
The appeal of the Consumers Union states that the draft order was published without prior elaboration with specialists in the pharmaceutical sector and was not discussed with the clusters whose interests it affects (patient organizations, pharmaceutical manufacturers and others). Moreover, most importantly, the document does not have pharmacoeconomic calculations and analysis of the possible consequences for Ukraine on the economic and physical availability of medicines. After all, this document deals with the revolutionary reformatting of regulatory approaches and the removal from established European practice.
The Consumers Union notes that the current revision of the corresponding draft document does not meet the stated goals regarding harmonization of the legislation of Ukraine with the legislation of the European Union. In addition, it is noted that its adoption will increase pressure on pharmaceutical manufacturers and entail a rise in the price of medicines.
The full text of the appeal can be found by the link
