Thus, in accordance with the text of the Decree, the decision of the National Security and Defense Council of Ukraine of July 30, 2021 “On the state of the national health care system and urgent measures to provide Ukrainian citizens with medical care” was put into effect.
The Cabinet of Ministers of Ukraine to ensure by December 1, 2021 the development and approval of the Strategic Plan for the development of public health for the period up to 2030, defining deadlines for implementation and clear mechanisms to ensure equal access of citizens of Ukraine to timely, safe and quality emergency, primary, secondary (specialized), tertiary (highly specialized), palliative care and rehabilitation in the field of health care, providing, in particular:
– in terms of medical devices for market operators:
– submission of the draft Law of Ukraine “On Medical Devices”, developed in accordance with the norms of European directives, to the Verkhovna Rada of Ukraine by December 15, 2021;
– taking measures to minimize the harmful effects of self-medication on health, in particular, by establishing a moratorium until January 1, 2024 on the provision in television, radio, media of any advertising information about medicines, medical devices, prevention methods, diagnosis, treatment and rehabilitation;
– providing support in the Verkhovna Rada of Ukraine to the draft Law of Ukraine “On Amendments to the Criminal Code of Ukraine on Liability for Counterfeiting of Medical Products and Similar Crimes Threatening Health” (registration 91 4491) in order to implement the provisions of the Council of Europe Convention on Counterfeiting products and similar crimes threatening health care, ratified by the Law of Ukraine of June 7, 2012 № 4908 – VI.
In addition, the Government is instructed to organize and consult with international partners in bilateral and multilateral formats to gain and use international experience in the construction and operation of the national health care system, including to attract international technical assistance to receive health care facilities. state-of-the-art medical technologies and equipment, as well as to counteract the spread of acute respiratory disease COVID-19 caused by the coronavirus SARS-CoV-2 in Ukraine.
– in terms of medicines for market operators:
-providing support in the Verkhovna Rada of Ukraine to the draft Law of Ukraine “On Medicinal Products” (registration № 5547) in order to harmonize the legislation of Ukraine in the field of circulation of medicinal products with the legislation of the European Union, namely:
– reforming the system of state bodies in the field of circulation of medicines, establishing a state body of European standard – authorized competent body and establishing proper communication of the newly formed body with the relevant structures of the European Union, improving approaches to licensing and inspection of activities related to the circulation of medicines. mandatory application of relevant good practices (GxP) at all key stages of drug circulation, bringing the procedure of state registration and liability of holders of registration certificates for medicinal products in line with European directives, the mandatory introduction of adapted to the European Union approaches to pharmacovigilance, promotion and advertising of medicines, as well as improving the requirements for the activities of pharmacies as health care facilities;
– harmonization of national legislation with the requirements of Directive 2002/46 / EC of the European Parliament and of the Council of the European Union on the harmonization of the laws of the Member States relating to organic food additives of 10 June 2002, in particular as regards the protection of the population from the adverse consequences of unfair distribution of biologically active supplements by establishing legislative restrictions on the sale of dietary and food supplements by health care institutions;
– ensuring the intensification of work on the signing of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA Agreement) between Ukraine and the European Union in order to mutually recognize the results of inspections of the production of medicines for compliance with Good Manufacturing Practice (GMP) and quality control results means;
– taking measures to stimulate the development of domestic production of immunobiological drugs (vaccines, toxoids, immunoglobulins, sera, bacteriophages, other drugs for the specific prevention of infectious diseases) for the prevention of the most common infectious diseases in Ukraine and the world;
The decree came into force on the day of its publication.
The full text of the Decree and the decision of the National Security and Defense Council is available at the link.