Article 19. Permits in the field of healthcare Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

Home / RLA / Article 19. Permits in the field of healthcare Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

1. The permits in the field of healthcare are:

1) a sanitary and epidemiological conclusion on the compliance of an object of high epidemic significance with regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

2) permission to handle pathogenic biological agents and its annex;

3) certificate of state registration of products;

4) registration certificate for a medicinal product and a medical device;

5) permission to conduct an interventional clinical trial of a medicinal product or medical device;

6) certificate of a specialist in the field of healthcare.

2. The validity period of permits in the field of healthcare is established by the Law of the Republic of Kazakhstan "On Permits and Notifications".

3. In case of non-fulfillment of the order to eliminate violations of the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare, the officials who issued the permit shall suspend its validity on the grounds and in accordance with the procedure provided for by this Code and the laws of the Republic of Kazakhstan.

4. In case of failure to submit an application for the elimination of violations by the owner of the permit document before the expiration of the period of suspension of the permit document in the field of healthcare, the officials who issued the permit document, within ten working days from the expiration of the specified period, initiate the withdrawal (revocation) of the permit document in court.

5. The reissue of permits is allowed without additional or repeated studies (tests), with the exception of subitems 4) and 5) of paragraph 1 of this Article, in the following cases:

1) identification of errors (typos) in the document;

2) re–registration of the applicant individual entrepreneur, change of his name or legal address;

3) changes in the name and (or) location of the applicant legal entity, the manufacturer of the product;

4) changing the address of the location of the object without physically moving it.

The footnote. Article 19 as amended by the Law of the Republic of Kazakhstan dated 05/21/2022 No. 123-VII (effective six months after the date of its first official publication).

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Republic of Kazakhstan

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