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

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.

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 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). Pages of data are numbered, stitched, make sure the authorized signature and the companies are sealed (in the presence).

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.

7. In case of availability of the bases for renewal of the license the licensee shall submit within one month to body of licensing the application for renewal of the license in form according to appendix 4 and the documents determined by part seven of article 15 of the Law.

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 which list is approved by MZ;

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

in the place (places) of its production which, (which) are specified in the statement for receipt of the license and in documents which were attached to it (taking into account the changes made to them provided by the licensee to body of licensing).

10. At the place of residence (stay) of the patient it can be provided:

primary medical care;

specialized medical care which can be provided in out-patient conditions;

emergency and emergency medical care;

palliative care, including psychological assistance;

help in passing of medical rehabilitation;

exit (mobile) consulting and diagnostic help.

11. In medical practice the licensee uses only those methods of prevention, diagnostics, treatment, rehabilitation, medicines, medical products, products of medical appointment and disinfectants which are not prohibited to application of MZ.

12. Subject of managing which is healthcare institution:

Shall have 1) approved in the procedure established by the legislation:

the charter of healthcare institution or regulations on health care institution (depending on form of business);

staff list;

regulations on its structural divisions (in particular, isolated);

job descriptions of workers;

regulations of healthcare institution;

clinical routes of the patient are developed according to clinical protocols and standards of medical care (medical standards) approved by the Ministry of Health;

2) No. 215 Is excluded according to the Resolution of the Cabinet of Ministers of Ukraine of 13.03.2019.

The name of healthcare institution shall correspond to the name in the list of organizations approved by MZ and/or other central executive body.

13. The licensee shall:

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