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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 20, 2020 No. KR DSM-288/2020

About approval of rules of implementation of advertizing of medicines and medical products

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 05.09.2022 No. KR DSM-94)

According to Item 1 of article 56 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed rules of implementation of advertizing of medicines and medical products.

2. Recognize invalid:

1) the order of the Minister of health and social development of the Republic of Kazakhstan of February 27, 2015 No. 105 "About approval of Rules of implementation of advertizing of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 10667, it is published on April 17, 2015 in information system of law of Ad_let);

2) Item 2 of the List of orders in the field of health care to which changes are made the Minister of Health of the Republic of Kazakhstan approved by the order of April 22, 2019 No. KR DSM-44 "About introduction of amendments to some orders of the Ministry of Health of the Republic of Kazakhstan and the Ministry of health and social development of the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 18582, it is published on May 2, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

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

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

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

Minister of Health of the Republic of Kazakhstan

A. Tsoi

Approved by the Order Minister of Health of the Republic of Kazakhstan of December 20, 2020, No. KR DSM-288/2020

Rules of implementation of advertizing of medicines and medical products

Chapter 1. General provisions

1. These rules of implementation of advertizing of medicines and medical products (further – Rules) are developed according to Item 1 of article 56 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code), and also the Law of the Republic of Kazakhstan "About advertizing" and determine procedure of advertizing of medicines and medical products.

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

1) advertizing of medicines and medical products (further – advertizing) – the information distributed and (or) placed in any form, by means of any means, separate data or the set of data on medicines and medical products intended for the indefinite group of people, containing promoting their promotion and realization;

2) scientific information material – data or the set of data on medicine and medical product containing the scientific and analytical data distributed in form of scientific articles, methodical instructions, education guidances;

3) the applicant – physical person or legal entity (the organization – the vendor, the distributor, representation) or their authorized representative, authorized to submit the application, documents and materials for evaluating promotional materials of medicines and medical products;

4) the promotional material – the documents and materials used when evaluating advertizing of medicines and medical products, on compliance to requirements of the legislation of the Republic of Kazakhstan in the field of health care, received from the applicant;

5) the advertizing module – the teksto-graphical message of advertizing nature on medicines and medical products executed on paper (the leaflet, liflt, another) and extended in the organizations of health care and (or) placed in printing mass media;

6) advertizing Article – the information Article containing advertizing of medicine and medical product;

7) advertizing audioroller – the audiowork of advertizing nature about medicines and medical products placed on radio and Internet resources;

8) advertizing banner – one or number of teksto-graphical representations of advertizing nature about medicines and medical products placed on Internet resources;

9) the advertizing video – the audiovisual work of advertizing nature about medicines and medical products placed on television channels and Internet resources;

10) storyboard – the sequence of the drawings serving as supportive application during creation of videos and advertizing banners;

11) the advertizing distributor – the physical person or legal entity performing distribution and placement of the ad info by provision and (or) uses of property, including technical means of TV and radio broadcasting and different ways;

12) No. KR DSM-94 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 05.09.2022

Chapter 2. Procedure of advertizing of medicines and medical products

3. Distribution and advertizing of medicines and medical products is performed in mass media, electronic information resources in the organizations of health care.

4. Advertizing is provided in the Kazakh and Russian languages and contains the complete and authentic data on medicine or medical product promoting their rational application.

5. Advertizing corresponds to the instruction on medical application of medicine (leaf insert), instructions on medical application or the operational document on medical product.

When entering into the instruction on medical application of medicine and medical product of the changes influencing content of the extended advertizing, the made changes are reflected in promotional materials.

6. Advertizing does not exaggerate pharmacological properties and therapeutic indications of the advertized medicine, scope for medical products, and also excludes comparisons with other medicines and medical products.

Advertizing does not mislead consumers by means of abuse of their trust, including concerning characteristics, structure, consumer properties, the cost (price), expected results of application, results of researches and testing.

Advertizing is easily read, printed by accurate and legible font, is reliable and recognizable (without special knowledge or application of special means).

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