Unofficial transfer (c) Soyuzpravoinform LLC

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of August 24, 2022 No. 1525

About approval of approval procedure and carrying out the program of expanded access for patients to the unregistered medicines and programs of access for subjects of research (patients) to the researched medicine after completion of clinical testing and changes in procedure for import to the territory of Ukraine of the unregistered medicines, standard samples, reagents

According to Article 8-1, of paragraphs of the thirteenth, fourteenth of part six of article 17 of the Law of Ukraine "About medicines", article 44-1 of the Law of Ukraine of "Basis of the legislation of Ukraine about health protection", for the purpose of settlement of provision by the seriously ill patient to patients of access to original (innovative) medicines in Ukraine on a grant basis and harmonizations of the national legal system with the European Union law, I ORDER:

1. Approve the Approval procedure and carrying out the program of expanded access for patients to the unregistered medicines and programs of access for subjects of research (patients) to the researched medicine after completion of clinical testing which is applied.

2. Approve Changes according to the procedure of the import to the territory of Ukraine of the unregistered medicines, standard samples, reagents approved by the order of the Ministry of Health of Ukraine of April 26, 2011 No. 237, registered in the Ministry of Justice of Ukraine on August 11, 2011 for No. 965/19703, which are applied.

3. Determine that:

consideration of the provided materials for approval of health protection of Ukraine of programs of expanded access for patients by the Ministry to the unregistered medicines and the program of access for subjects of research (patients) to the researched medicine after completion of clinical testing and changes in them, is carried out by the state company "State Expert Centre of the Ministry of Health of Ukraine" on a grant basis;

it is forbidden to use the unregistered medicines, within programs of expanded access for patients to the unregistered medicines and the program of access for subjects of research (patients) to the researched medicine after completion of clinical testing, development and/or production of which it is performed in the country, officially by acknowledged Ukraine as the state aggressor;

the unregistered medicines allowed for use in the territory of Ukraine within programs of expanded access for patients to the unregistered medicines and the program of access for subjects of research (patients) to the researched medicine after completion of clinical trial are applied by healthcare institutions, the doctor or the physical person - the entrepreneur having the license for implementation of economic activity on medical practice without the right of retail sale.

4. (I. Zadvornykh) to provide to management of provision of medicines in accordance with the established procedure submission of this order on state registration in the Ministry of Justice of Ukraine.

5. To impose control over the implementation of this order on the First Deputy Minister A. Komaridu.

6. This order becomes effective from the date of its official publication, except the Changes approved by this order which become effective from the date of the termination or cancellation of warlike situation in Ukraine.

Approved by the Order of the Ministry of health protection of Ukraine on August 24, 2022, No. 1525

Approval procedure and carrying out the program of expanded access for patients to the unregistered medicines and programs of access for subjects of research (patients) to the researched medicine after completion of clinical testing

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