ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 19, 2009 No. 743

About approval of Rules of assessment of conditions of production and systems of quality assurance in case of state registration of medicine or medical product

According to article 71 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of assessment of conditions of production and system of quality assurance in case of state registration of medicine or medical product.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work (Bismildin F. B.) provide official publication of this order in mass media, after its state registration in the Ministry of Justice of the Republic of Kazakhstan.

4. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of March 2, 2009 No. 115 "About approval of Rules of evaluating conditions of production in case of state registration of medicines" (registered in the Register of state registration of regulatory legal acts for No. 5620, No. 57 published in the Yuridicheskaya Gazeta newspaper of April 17, 2009 (1654)).

5. To impose control of execution of this order on the Vice-Minister of Health E. A. Birtanov.

6. This order becomes effective after ten calendar days after its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 743

Rules of assessment of conditions of production and system of quality assurance in case of state registration of medicine or medical product

Chapter 1. General provisions

1. These rules of assessment of conditions of production and system of quality assurance in case of state registration of medicine or medical product (further - Rules) determine procedure for evaluating conditions of production and system of quality assurance of medicine or medical product (further - production assessment).

2. Assessment of production is performed by the state expert organization in the sphere of drug circulation and medical products (further - the expert organization) by visit of the facility for production of medicine or medical product (further - the manufacturing organization) for the purpose of confirmation:

1) for medicines - compliance of production, production site (platform) to the requirements of the standard of proper production practice (GMP) approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 27, 2015 No. 392 "About approval proper pharmaceutical the practician" (it is registered in the Register of state registration of regulatory legal acts at No. 11506) (further - the order No. 392), except for domestic manufacturers of the medicines having the certificate of GMP and for medical products - to requirements of quality management system in case of production of the medical products ISO (ISO) 13485;

2) compliance of the actual data obtained during evaluating production, to the data declared in the registration file in case of examination of medicine or medical product.

3. The objects performing both complete, and incomplete (packing, packaging and marking) cycles of production of medicine or medical product, and also production of medicines for clinical testing are subject to assessment of production.

4. Assessment of production is performed in cases:

1) examinations of medicines of the producer organizations which were earlier not registering products in the Republic of Kazakhstan or earlier not delivering products from production sites (platforms) to the Republic of Kazakhstan, except for producers of the countries of the region of the International conference on harmonization of technical requirements to registration of medicines for medical application (ICH) (Aysieych);

2) examinations of medical products 2a (sterile), 2b and 3 classes of safety depending on degree of potential risk of application of the producer organizations which were earlier not registering products in the Republic of Kazakhstan or earlier not delivering products from production sites (platforms) to the Republic of Kazakhstan;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info