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The new Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of Medical Practice Licensing" (hereinafter – «Draft Resolution») has been published for public consideration on November 3, 2015, at the Ministry of Health official website.
It is noteworthy that the proposed Draft Resolution possesses some changes in comparison to the acting Licensing Requirements to Medical Practice, which were approved by the Ministry of Health Order № 49 as of 02.02.2011 (hereinafter – «acting Licensing Requirements»).
One of the adjustments is the statutory permit to provide medical services to the patient at the place of his/her residence. In particular, the patient may receive the primary, post primary (under outpatient treatment), emergency, palliative care, medical rehabilitation, and on-site diagnostic services.
The Draft Resolution also entrenches the provisions for medical practice licensing of the individuals entrepreneurs, who do not have a special education and do not satisfy the unified qualification requirements approved by the Ministry of Health of Ukraine. In this case the individual entrepreneur should assure the staff manning with medical and non-medical employees in accordance with the declared specialties.
In addition, the Draft Resolution specifies the definition of the «medical practice». In accordance with the adjusted definition the medical practice may be exercised not only by the health care facilities and individual entrepreneurs, but also by medical offices of the business entities without the establishment of the health care facility. Such medical office shall act on the grounds of the business entity executive documents and the Statute of the medical office.
Moreover, the Draft Resolution provides a range of requirements to the development of unified management and quality control system for medical services rendered by the business entity. Therefore, the business entity should ensure the quality control for medical services; provide for in vitro and in vivo control of the laboratory studies quality (if there is a laboratory), etc.
On the overall, the Draft Resolution focuses on the improvement of the relations between the applicant and licensing authority in the field of license acquisition and conduct of the declared business activity.
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