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of February 15, 2022 No. 2054-IX
About modification of some legal acts of Ukraine concerning provision settlement to patients of medicines from compassion
The Verkhovna Rada of Ukraine decides:
I. Make changes to such legal acts of Ukraine:
1. To add bases of the legislation of Ukraine on health care (The sheet of the Verkhovna Rada of Ukraine, 1993, No. 4, of Art. 19 with subsequent changes) with Article 44-1 of the following content:
"Article 44-1. Use of medicines within programs 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
Within programs of expanded access for patients to the unregistered medicines or programs of access for subjects of research (patients) to the researched medicine after completion of clinical trial approved by the central executive body which provides forming and realizes state policy in the field of health care the doctor has the right, on condition of receipt of the informed consent of the patient to medical intervention according to this Law, to appoint and/or apply in medical practice the medicines which are not registered in Ukraine, or the registered medicines according to the indications which are not specified in the instruction for medical application or the short characteristic of medicine and/or medicines which are not brought in industry standards in the field of health care.
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