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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 2, 2016 No. 285

About approval of Licensed conditions of implementation of economic activity on medical practice

(as amended on 27-12-2023)

According to Item and paragraph one of part two of article 9 of the Law of Ukraine "About licensing of types of economic activity" the Cabinet of Ministers of Ukraine decides 15 parts one of Article 7:

Approve Licensed conditions of implementation of economic activity on medical practice which are applied.

Prime Minister of Ukraine

A. Yatsenyuk

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 2, 2016 No. 285

Licensed conditions of implementation of economic activity on medical practice

General part

1. These Licensed conditions establish organizational, personnel and production requirements to material and technical resources of the licensee, obligatory for accomplishment when implementing economic activity on medical practice, and also determine the exhaustive list of the documents enclosed to the application for receipt of the license for implementation of economic activity on medical practice (further - the license).

2. The licensee shall fulfill requirements of these Licensed conditions, and the license applicant - it to correspond.

3. Action of these Licensed conditions extends to all legal entities, irrespective of their form of business and physical persons of entrepreneurs which perform economic activity on medical practice.

Action of these Licensed conditions does not extend to the economic activity connected with implementation of medicolegal histology, forensic medical examination, medicolegal immunology, medicolegal criminalistics, medicolegal toxicology, medicolegal cytology, forensic-psychiatric examination.

4. Terms in these Licensed conditions are used in such value:

the isolated structural division - division of healthcare institution which is located out of its main location and performs economic activity on medical practice;

economic activity on medical practice (further - medical practice) - type of economic activity in the field of health care which is made by healthcare institutions and physical persons entrepreneurs for the purpose of delivery of health care and medical attendance based on the license.

Other terms are used in the values determined by Bases of the legislation of Ukraine on health protection, the Laws of Ukraine "About personal data protection", "About rehabilitation in the field of health care", "About licensing of types of economic activity" (further - the Law).

5. The license applicant for its obtaining submits the method provided by part one of article 10 of the Law to body of licensing the statement for receipt of the license in form according to appendix 1.

6. To the statement for receipt of the license, except documents, the stipulated in Article 11 Laws, are added signed by the license applicant or person of the data on material and technical resources condition, personnel availability authorized by it with indication of its educational and qualification level (appendix 2).

In case of formation by the legal entity of several healthcare institutions of the data on material and technical resources condition, personnel availability with indication of its educational and qualification level are filled with the subject of managing for each healthcare institution separately.

In case of implementation by physical person entrepreneur of medical practice in several places of its production of the data on material and technical resources condition, personnel availability with indication of its educational and qualification level are filled for each place of implementation separately.

The list of documents, enclosed to the application for receipt of the license (appendix 3), moves in duplicate in case of submission of documents in paper form.

7. In case of the bases for renewal of the license determined by part seven of article 15 of the Law, the physical person - the entrepreneur, being the heir of the licensee, shall within one month from the date of acquisition of right of such right to submit to body of licensing the application for renewal of the license in form according to appendix 4.

Are enclosed to the application for renewal of the license:

certified by the heir of the copy (photocopy) of the documents confirming availability of the bases for renewal of the license;

the document determined by paragraph one of Item of 6 presents of licensed conditions for the purpose of establishment of compliance of the heir to requirements of these licensed conditions.

7-1. The license applicant, the licensee, the heir cannot be directly or indirectly under control (in the value given in article 1 of the Law of Ukraine "About protection of the economic competition") residents of the states performing the armed aggression against Ukraine (in the value given in article 1 of the Law of Ukraine "About defense of Ukraine") and/or actions of which create conditions for emergence of the military conflict and use of military force against Ukraine.

7-2. The documents constituted by the license applicant, the licensee, the heir according to the Law and these Licensed conditions shall be stated in state language and are signed by the license applicant, the licensee the heir or other representative on it person.

In case of registration on paper documents are constituted by means of the printing means (the font of 12 printing Items in size is applied) or hand-written method (printing letters and figures), and pages of data on material and technical resources condition, personnel availability with indication of its educational and qualification level are numbered.

The documents submitted electronically are drawn up according to requirements of the legislation in the field of electronic document management.

In case of signing and/or submission of documents by the authorized person of the license applicant, the licensee, the heir the original document or the verified copy confirming its powers is attached to statements for obtaining and renewal of the license.

8. In case of reorganization of the licensee - the legal entity (separation, merge, accession or transformations) the licensee provides proper storage of medical documentation.

Organizational requirements

9. Medical practice by the licensee is made:

on medical professions and professions of junior specialists with medical education, rehabilitation specialists which list is approved by MZ;

by types of medical care (emergency, primary, specialized, palliative, medical rehabilitation);

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