ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 28, 2016 No. 569

About modification of the order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269 "About approval of Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan"

According to the subitem 84) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269 "About approval of Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts for No. 10003, it is published in information system of law of Ad_let on January 8, 2015) the following change:

The rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan (further - Rules), approved by the specified order to be reworded as follows according to appendix to this order.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) the direction in printing and electronic type within five working days from the date of receipt of the registered this order of its copy in one copy in the state and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan to direct it to official publication in periodic printing editions and information system of law of Ad_let;

4) placement of this order on Internet resource of the Ministry of health and social development of the population of the Republic of Kazakhstan;

5) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), 3) and 4) of this Item.

3. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after ten calendar days after day of its first official publication.

Appendix

to the Order of the Minister of health and social development of the Republic of Kazakhstan of June 28, 2016 No. 569

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269

Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan (further - Rules), determine procedure for evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan and extend on the physical persons and legal entity performing pharmaceutical activities (further - the applicant), Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan (further - Committee), the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the expert organization).

2. In these rules the following terms and determinations are used:

1) the subject in the field of drug circulation, products of medical appointment - the physical persons or legal entities performing pharmaceutical activities;

2) assessment of safety and quality of medicines, products of medical appointment and medical equipment (further - estimates of safety and product quality) - determination of compliance of safety and quality of the medicines registered in the Republic of Kazakhstan, products of medical appointment to data of the registration file, regulating documents on standardization based on which they were registered in the Republic of Kazakhstan;

3) the regulating document on control of safety and quality of medicine - the document establishing the complex of requirements to testing, techniques of their carrying out and to admissible regulations of quality intended for quality control of medicine after its release in the address, approved with the expert organization when conducting examination according to the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 736 "About approval of Rules of conducting examination of medicines, products of medical appointment and medical equipment" (No. registered in the Register of state registration of regulatory legal acts 5926);

4) the authorized person of the producer of medicine - the person designated by producer of medicines, performing confirmation of conformity of medicines to the requirements established in case of their state registration and the guaranteeing production of medicine according to 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" (No. registered in the Register of state registration of regulatory legal acts 11506) (further - GMP);

5) medicine series - specific amount of the medicines received as a result of engineering procedure;

6) the declaration of safety and quality - the document signed by the authorized representative of the producer of product of medical appointment or the authorized person of the producer of medicine, certifying that the specified series (batch) of products was made, checked and released according to requirements of the license for production of the registration file and GMP of the countries of the region of the International conference on harmonization of technical requirements to registration of medicines for medical application (ICH) (further - GMP of the countries of the region of ICH), GMP of the Republic of Kazakhstan if is available system of pharmakonadzor of the owner of the registration certificate (further - GMP PK), the European international industry standard of quality management system of medical products (further - EN ISO 13485);

7) the countries of the region of the International conference on harmonization of technical requirements to registration of medicines for medical application (ICH) - the state, the requirement to registration of medicines in the territory of which are regulated by the authorized body which became the founder or the permanent member of the International council on harmonization of technical requirements to medicines for medical application: countries of the European Union, United States of America, Japan, Switzerland, Canada;

8) the authorized representative of the producer of product of medical appointment - the legal entity or physical person registered as the individual entrepreneur, authorized by the power of attorney of the producer of product of medical appointment to represent its interests, to carry out monitoring of safety and to perform the mandatory requirements imposed to products of medical appointment as the legislation of the Republic of Kazakhstan in the field of drug circulation, products of medical appointment and medical equipment;

9) the regulating document on control of safety and product quality of medical appointment - documents (international, regional), the national standards, standards of the organization establishing complex of quality requirements, to safety, transportation and storage of products of medical appointment and also to techniques of testing;

10) series of product of medical appointment - the set of assigned amount of one or more components of product of medical appointment or product of medical appointment from one type, model, type, the size, structure made in identical conditions, having identical characteristics and quality in the set limits;

11) the conclusion about safety and product quality - the document issued by the expert organization for results of the carried-out assessment of safety and product quality for realization of presence of medicines, products of medical appointment in the market;

12) serial assessment of safety and product quality - assessment of safety and quality of medicines, products of medical appointment performed with evaluating conditions of production and testing of product samples;

13) products - the medicines and products of medical appointment registered according to the Rules of state registration, re-registration and modification of the registration file of medicines, products of medical appointment and medical equipment approved by the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 735 (registered in the Register of state registration of regulatory legal acts No. 5935) and allowed for medical application in the Republic of Kazakhstan;

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