ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

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

According to Item 2 of article 50 of the Law of the Republic of Kazakhstan of April 6, 2016 "About legal acts" I ORDER:

1. Approve the list of 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 to which changes are made (further - the List), according to appendix to this order.

2. To provide to committee of pharmacy 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) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

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

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

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

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 of the Republic of Kazakhstan of April 22, 2019 No. KR DSM-44

The list of 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 to which changes are made

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of November 24, 2009 No. 765 "About approval of the List of the medical equipment which is gage" (it is registered in the Register of state registration of regulatory legal acts at No. 5891, it is published on January 22, 2010 in the Yuridicheskaya Gazeta newspaper No. 10 (1806)) the following changes:

state heading in the following edition:

"About approval of the List of the medical products which are gage";

state Item 1 in the following edition:

"1. Approve the enclosed List of the medical products which are gage";

in the List of the medical equipment which is gage, approved by the specified order:

state heading in the following edition:

"The list of the medical products which are gage";

line:

"

№ payment order	Name of medical equipment
		";

state in the following edition:

"

№ payment order	Name of medical product
		".

 

2. Bring in 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, products of medical appointment and medical equipment" (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) the following changes:

state heading in the following edition:

"About approval of Rules of implementation of advertizing of medicines and medical products";

state Item 1 in the following edition:

"1. Approve Rules of implementation of advertizing of medicines and medical products according to appendix to this order";

in Rules of implementation of advertizing of the medicines, products of medical appointment and medical equipment approved by the specified order:

state heading in the following edition:

"Rules of implementation of advertizing of medicines and medical products in the Republic of Kazakhstan";

to state heading of Chapter 1 in the following edition:

"Chapter 1. General provisions";

state Items 1 and 2 in the following edition:

"1. These rules of implementation of advertizing of medicines and medical products (further - Rules) are developed according to the Law of the Republic of Kazakhstan of December 19, 2003 "About advertizing", with article 18 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", and determine procedure of advertizing of medicines and medical products in the Republic of Kazakhstan.";

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

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

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

3) the applicant - physical person or legal entity (the manufacturing organization, the distributor, representation) or their authorized representative, authorized to submit the application, documents and materials for advertizing;

4) the promotional material - the documents and materials used when evaluating advertizing of medicines and medical product, on compliance to the legislation of the Republic of Kazakhstan in the field of health care, received from the applicant and from the state information systems;

5) the advertizing module - the advertizing prototype executed and extended on paper (the leaflet, liflt, another);

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

7) storyboard - the sequence of the drawings serving as supportive application during creation of video clips;

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

9) implementation of advertizing of medicines and medical products - distribution of advertizing of medicines and medical products of the Republic of Kazakhstan corresponding to the legislation in the field of health care in the specialized seal intended for health and pharmaceutical workers in mass media within fixed terms;

10) the state expert organization in the field of drug circulation and medical products (further - the expert organization) - the organization determined by authorized body in the field of health care for evaluating advertizing of medicines and medical products;

11) the advertiser - the physical person or legal entity which is advertisement source for production, distribution and advertizing;

12) the advertisement producer - the physical person or legal entity performing reduction of advertisement to form, ready for distribution and placement.";

to state heading of Chapter 2 in the following edition:

"Chapter 2. Requirements to implementation of advertizing of medicines and medical products";

to state part one of Item 3 in the following edition:

"3. Distribution and placement of medicines and medical products are allowed in periodic printing editions, other mass media and in the organizations of health care.";

in Item 5:

the paragraph one to state in the following edition:

"5. Do not treat advertizing of medicines and medical products:";

3) to state the subitem in the following edition:

"3) information on the physical and (or) legal entity making or realizing medicine and (or) medical product;";

in Item 7:

3) to state the subitem in the following edition:

"3) it is performed in such type that it was clear that the advertized means is medicine and (or) medical product;";

5) to state the subitem in the following edition:

"5) excludes comparisons with other medicines and medical products;";

8) to state the subitem in the following edition:

"8) corresponds to the instruction on medical application of medicine and medical product approved by authorized body in the field of health care in case of state registration and to the operational document for 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.";

in Item 9:

the paragraph one to state in the following edition:

"9. Advertizing of medical products contains the following obligatory information:";

5) to state the subitem in the following edition:

"5) the clear and evident recommendation before appointment and application it is attentive to read the instruction on medical application (the operational document for medical product);";

to state heading of Chapter 3 in the following edition:

"Chapter 3. Procedure for evaluating promotional materials of medicines and medical products";

in Item 12:

3) and 4) to state subitems in the following edition:

"3) the operational document (in case of provision of advertizing on medical products);

Data on the documents certifying state registration of medicines and medical products, assessment of safety and efficiency of medicines and medical products, the instruction on medical application the expert organization receives 4) from the corresponding state information systems in the form of electronic documents.";

be reworded as follows appendix 1 according to appendix 1 to this List;

be reworded as follows appendix 2 according to appendix 2 to this List;

to state the right upper corner of appendix 3 in the following edition:

"Appendix 3 to Rules of implementation of advertizing of medicines and medical products in the Republic of Kazakhstan";

be reworded as follows appendix 4 according to appendix 3 to this List.

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