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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of April 15, 2022 No. 471

Some questions of the emergency state registration of medicines, medical immunobiological supplies, blood medicines which are made or delivered to Ukraine during the period of action of warlike situation, under obligations

According to Presidential decrees of Ukraine of February 24, 2022 "About introduction of warlike situation in Ukraine" and of March 14, 2022 No. 133 "About prolongation of effective period of warlike situation in Ukraine" the Cabinet of Ministers of Ukraine decides No. 64:

1. No. 673 is excluded according to the Resolution of the Cabinet of Ministers of Ukraine of 04.07.2023

2. Make changes which are applied to resolutions of the Cabinet of Ministers of Ukraine.

3. Ceased to be valid according to the Resolution of the Cabinet of Ministers of Ukraine of 19.06.2023 No. 650

4. Determine that effective period of registration certificates on medicines which are registered according to requirements of the Procedure for the emergency state registration of medicines, medical immunobiological supplies, blood medicines which are made or delivered to Ukraine during the period of action of warlike situation under obligations, is prolonged in the territory of Ukraine from expiry date of the registration certificate for one year and/or for action of warlike situation in Ukraine, and/or for six months from the date of the termination or cancellation of warlike situation in Ukraine with introduction of information on prolongation of effective period of the registration certificate for such medicine in the State register of medicines.

Information on the extended validity of the registration certificate updated in the State register of medicines on medicine certifies force of state registration of such medicine and does not require issue new or replacements of the valid registration certificate.

At the request of person who submitted the application for the emergency state registration of medicine, term during which it is allowed for use in the territory of Ukraine it can be reduced according to the decision of the Ministry of Health.

5. This resolution becomes effective from the date of its publication and is effective within six months from the date of the termination or cancellation of warlike situation.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of April 15, 2022, No. 471

Procedure for the emergency state registration of medicines, medical immunobiological supplies, blood medicines which are made or delivered to Ukraine during the period of action of warlike situation, under obligations of ceased to be valid according to the Resolution of the Cabinet of Ministers of Ukraine of 04.07.2023 to No. 673

Approved by the Resolution of the Cabinet of Ministers of Ukraine of April 15, 2022 No. 471

Changes which are made to resolutions of the Cabinet of Ministers of Ukraine

1. The resolution of the Cabinet of Ministers of Ukraine of January 15, 1996 No. 73 "About approval of the Regulations on control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards" (1996, No. 5, the Art. 178) to add ZP of Ukraine with Item 5 of the following content:

"5. Determine that for action of warlike situation for the purpose of uninterrupted providing healthcare institutions and citizens with medical immunobiological supplies, for control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards according to the procedure determined by the order of the Ministry of Health, filing of applications on issue of the conclusions about compliance of medical immunobiological supplies to requirements of the state and international standards and issue of the conclusions about compliance of medical immunobiological supplies to requirements of the state and international standards is performed in electronic form.

Due to the introduction of warlike situation to the separate decision of Public service on medicines and control of drugs the conclusion about compliance of medical immunobiological supplies to requirements of the state and international standards, including the medical immunobiological supplies in foreign packaging made for needs of the markets of other countries is issued without carrying out laboratory control, the bases for which are determined by the order of the Ministry of Health. In that case responsibility for control of quality of series of medical immunobiological supplies is born by authorized persons of subjects of managing which according to licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by the medicines, import of medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 (The Official Bulletin of Ukraine, 2016, No. 99, stations 3217), bear responsibility for quality and safety of the medicines imported by them.".

2. In the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376 "About approval of the Procedure for state registration (re-registration) of medicines and the amount of collection for their state registration (re-registration)" (The Official Bulletin of Ukraine, 2005, No. 22, Art. 1196; 2015, No. 24, Art. 671):

1) to add the resolution with Item 1-1 of the following content:

"1-1. Determine that for action of warlike situation:

and within six months from the date of the termination or cancellation of warlike situation the current of term for filing of application about re-registration of the medicine determined by the paragraph the seventh Item 10 of the Procedure approved by Item 1 of this resolution stops. After six months from the date of the termination or cancellation of warlike situation the current of the specified terms proceeds taking into account time which passed to their stop;