ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of March 20, 2013 No. 167

About approval of Rules of issue of permission to advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan

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

1. Approve Rules of issue of permission to advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan according to appendix 1 to this order.

2. Recognize invalid some orders in the field of health care according to appendix 2 to this order.

3. To committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan (Esimov D. S.):

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

2) after state registration of this order to provide its placement on Internet resource of the Ministry of Health of the Republic of Kazakhstan.

4. To department of legal service of the Ministry of Health of the Republic of Kazakhstan (Danayeva Zh. Zh.) after state registration of this order to provide official publication in mass media.

5. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Bayzhunusov E. A.

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

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of March 20, 2013 No. 167

Rules of issue of permission to advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan

1. General provisions

1. These rules of issue of permission to advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan (further - Rules) are developed according to Item 1 of 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 approval procedure on advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan with use of the State E-licensing database (further - GBD ate).

2. Issue of permission to advertizing of medicines, products of medical appointment and medical equipment is performed by Public institution "Department of Committee of control of medical and pharmaceutical activities for the city of Almaty" (further - Department).

3. The compulsory provision of issue of permission to advertizing of medicines, products of medical appointment and medical equipment is conducting preliminary expert examination of the promotional material in the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the expert organization).

4. Permission to advertizing is issued on effective period of the registration certificate of medicines, products of medical appointment and medical equipment in form according to appendix 2 to the Standard of the state service "Issue of Permission to Advertising of Medicines, Products of Medical Appointment and Medical Equipment" approved by the order of the Government of the Republic of Kazakhstan of October 8, 2012 No. 1262 (further - the Standard).

5. The advertized properties and characteristics of medicines, products of medical appointment and medical equipment irrespective of type of advertizing shall correspond to the instruction on medical application approved by authorized body in case of state registration, to the operational document for medical equipment.

6. Medicines, products of medical appointment and the medical equipment extended in quality of advertizing samples shall be registered in the Republic of Kazakhstan and be followed by the instruction on medical application, the operational document (for medical equipment).

7. These rules do not extend on below listed provided that in them references and advertizing approvals about medicine, products of medical appointment and medical equipment are not contained:

1) information concerning health or diseases of the person;

2) instruction on medical application, sales catalogs, price lists, reference materials, scientific information material, methodical and training materials of medical nature;

3) information on the physical person or legal entity making or realizing medicine, product of medical appointment and medical equipment;

4) drawing logo, the trade and/or international unlicensed name on the industrial output extended among health and pharmaceutical workers (handles, notebooks, bags, scrubs and another).

8. The advertizing distributor places advertizing only after provision by the advertiser of the permission to advertizing issued by Department.

9. Advertizing of the medicines released according to the recipe, and also the medicines containing drugs, psychotropic substances, precursors and being under control according to the legislation of the Republic of Kazakhstan is intended for health and pharmaceutical workers (further in the text - specialists) and can be performed only in the specialized printing editions intended for health and pharmaceutical workers.

Advertizing of the medicines released without recipe of products of medical appointment and medical equipment can be performed in mass media and in the organizations of health care and is intended for the population.

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

1) advertizing of medicines, products of medical appointment and medical equipment - the information distributed and placed in any form, by means of any means, containing separate data or the set of data on medicines, products of medical appointment and medical equipment promoting their promotion and realization intended for health, pharmaceutical workers and the population;

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

3) advertizing slogan - the phrase expressing the main idea of the advertizing appeal, read by one look as advertizing appeal;

4) permission to advertizing - the document issued by Department, confirming the diffusion right and advertisings;

5) 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 receipt of permission to advertizing;

6) the promotional material - the documents and materials used when conducting preliminary expert examination of advertizing of medicines, products of medical appointment and medical equipment, received from the applicant and from the state information systems;

7) the conclusion by results of conducting preliminary expert examination of the promotional material - the document issued by the expert organization, containing results of preliminary expert examination of promotional materials of medicine, product of medical appointment and medical equipment and the recommendation of production, distribution, placement and use of advertizing in the Republic of Kazakhstan (further - the conclusion of the expert organization);

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

9) advertizing Article - the information Article containing advertizing of medicine, product of medical appointment and medical equipment, intended for the population;

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

11) preliminary expert examination of advertizing of medicines, products of medical appointment and medical equipment - evaluating compliance of the filed documents and promotional materials to requirements of the legislation of the Republic of Kazakhstan in the field of advertizing;

12) 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.

11. Advertizing of medicines, products of medical appointment and medical equipment and the advertizing slogan used in it:

1) it is represented in the state and Russian languages easily readable, accurate and legible font;

2) it is performed in such type that it was clear that the advertized means is medicine, product of medical appointment, medical equipment;

3) promotes rational use of medicines, products of medical appointment and medical equipment;

4) does not exaggerate pharmacological properties and therapeutic indications of the advertized medicine, scope for products of medical appointment and medical equipment;

5) contains information on state registration in the Republic of Kazakhstan (date of issue, number of the registration certificate);

6) contains information on permission to advertizing (date of issue, number, completion date of permission to advertizing).

2. Procedure for issue of permissions to advertizing of medicine, product of medical appointment and medical equipment

12. Before filing of application on issue of permission to advertizing the applicant represents to the expert organization promotional materials (the module, audio-video, Article) for preliminary expert examination of medicine, product of medical appointment and medical equipment (further - preliminary expert examination).

13. Preliminary expert examination is carried out according to the statement on conducting preliminary expert examination in form according to appendix 1 to these rules, and also the agreement signed between the applicant and the expert organization and payments of cost according to the price list.

14. To the statement are provided in the state and Russian languages:

1) advertisement on paper and electronic carriers in the state and Russian languages (the module, Article, storyboard of video of advertizing, the advertizing text of audio of advertizing);

2) advertizing on video, audio recordings in the state and Russian languages in case of distribution on video radio channels;

3) the operational document (in case of provision of advertizing on medical equipment).

Receives data on the documents certifying state registration of medicines, products of medical appointment and medical equipment, assessment of safety and efficiency of medicines, products of medical appointment, the instruction on medical application the expert organization from the corresponding state information systems by means of the Portal in the form of electronic documents.

15. Advertizing for the population is stated in available language, distinguished without special knowledge or application of special means and shows that the advertized means is medicine, product of medical appointment or medical equipment.

16. Advertizing of medicines contains information necessary for their correct and rational application:

1) trade name;

2) international unlicensed name or structure;

3) the main indications to application;

4) method of application and doses;

5) main side effects;

6) main contraindications;

7) special instructions concerning children, expectant mothers, and also during feeding by breast;

8) leave conditions;

9) the clear and evident recommendation before appointment and application it is attentive to read the instruction on medical application;

10) the name, the address of the producer and/or sales representative in the Republic of Kazakhstan.

In advertizing of the medicines released according to the recipe the main medicinal interactions in addition are specified.

The advertizing intended for TV and radio channels contains information specified in subitems 1), 3), 7), 9) of this Item.

17. Advertizing of products of medical appointment and medical equipment contains:

1) trade name;

2) the main indications to application;

3) method of application;

4) main side effects in the presence;

5) main contraindications in the presence;

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

7) the name, the address of the producer and/or sales representative in the Republic of Kazakhstan.

The advertizing intended for TV and radio channels contains information specified in subitems 1), 2), 6) of this Item.

18. In advertizing of medicines, products of medical appointment and medical equipment for the population it is not allowed to use information in which:

1) there is description of symptoms of disease or clinical records which can lead to wrong diagnostics and self-diagnostics are provided;

2) impression of lack of need of medical consultations or surgeries is made;

3) images of changes in human body or parts of body before application are used;

4) it is inspired that health of the person can be worsened by non-use (not use) of the advertized products;

5) there are references to responses about recovery.

19. The expert organization after acceptance and registration of a statement carries out preliminary expert examination within 20 working days.

20. In case of detection of discrepancy of promotional materials to these rules the expert organization sends to the applicant of the note in writing.

The applicant in time who is not exceeding 10 calendar days represents to the expert organization promotional materials taking into account notes, at the same time time of ustraneniye of notes does not enter terms of conducting preliminary expert examination.

21. The result of conducting preliminary expert examination is drawn up by the act of expert evaluation of promotional materials in form according to appendix 2 to these rules based on which the conclusion of the expert organization for form according to to appendices 4, 5 to the Standard is created.

22. By results of conducting preliminary expert examination the Expert organization provides:

1) in Department on electronic and paper carriers:

conclusion of the expert organization;

the advertizing in the state and Russian languages (the module, Article, the text of advertisement (storyboard) of video records, the text of audio recording when advertizing on television channels and radio) certified by stamp of the expert organization "Expertise (No. _____ Date) Advertising Is Carried Out, First Name, Middle Initial, Last Name and the Signature of the Responsible Person";

2) to the applicant on paper:

the copy of the conclusion of the expert organization certified by the signature of the head of the expert organization (without advertizing appendix).

23. The negative conclusion is issued by the expert organization in cases:

1) failure to provide complete set of the documents specified in Items 13, 14 to these rules;

2) not compliance of advertizing to the legislation of the Republic of Kazakhstan in the field of advertizing;

3) not elimination of the notes exposed to the applicant when conducting examination in the terms established by these rules;

4) provision by the applicant of false information.

24. In case of the negative conclusion or response the applicant of the statement after the beginning of conducting preliminary expert examination, the cost of conducting preliminary expert examination does not return.

25. The act of expert evaluation of promotional materials, the copy of the conclusion, advertizing on electronic and papers, and also the documents submitted for examination are stored in the expert organization before the termination of effective period of permission to advertizing.

26. The department within eight working days issues to the applicant permission to advertizing of medicines, products of medical appointment and medical equipment.

27. The bases for refusal in issue of permission to advertizing of medicine, product of medical appointment and medical equipment are specified in Item 16 of the Standard.

Appendix 1

to Rules of issue of permission to advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan

Form

Заявитель:____________________________________________________________________________________________________

legal адрес____________________________________________________________________________________________

телефон______________________________________________________________________________________________________

факс_________________________________________________________________________________________________________

e-mail address заявителя______________________________________________________________________________

Applicant's representative _______________________________________________________________________________________

(First name, middle initial, last name, the position, the power of attorney is applied)

телефон______________________________________________________________________________________________________

факс_________________________________________________________________________________________________________

e-mail address of the applicant ______________________________________________________________________________

Statement

We ask ____________________________________________________________________________________________ present

(full name of the expert organization)

Carry out expertize of advertizing of medicine, product of medical appointment and medical equipment (necessary to emphasize)

trade наименование_________________________________________________________________________________________

international unlicensed name (in the presence) ___________________________________________________________

dosage form, dosage, packing (in the presence) _____________________________________________________________

conditions отпуска________________________________________________________________________________________________

at the same time we report that the specified medicine, the product of medical appointment and medical equipment (necessary to emphasize) is registered in the Republic of Kazakhstan. Registration certificate No. ______ "____" ______ _____ of year.

Medicine, product of medical appointment passed assessment of safety and quality in the Republic of Kazakhstan (the conclusion about safety and quality No. ___, date ___, it is issued __________________________________________________)

name of the organization

or confirmation of conformity (the certificate of conformity No. ___, date ______, is issued _____________________________________)

name of the organization

We enclose to the application:

the text of advertisement on paper and electronic carriers in the PDF format in the state and Russian languages;

advertisement on video, audio recordings in the state and Russian languages when advertizing on television channels and radio.

1.	The subject performing payment for conducting examination
1.	Name
3.	Legal address
4.	Actual address
5.	First name, middle initial, last name, position
6.	Phone
7.	Fax
8.	e-mail
9.	BIN
10.	IIN
11.	Bank
12.	Account No.
13.	Premium
14.	Code
15.	BIC

 

_____________________________ __________________

First name, middle initial, last name                         applicant Podpis

seal

 

The statement was adopted by ____________________________________ ________________

                                  (First name, middle initial, last name, position)                           (date)

Appendix 2

to Rules of issue of permission to advertizing of medicines, products of medical appointment and medical equipment in the Republic of Kazakhstan

Form

Act of expert evaluation of promotional materials of medicines, products of medical appointment, medical equipment

from "___" _______ ___ No. _____

 

№	Requirements imposed to advertizing	Execution of requirements in the provided information
1. General information
1.	Trade name
2.	International Non-proprietary Name (INPN) or structure (in the presence)
3.	Release form, dosage of active agent (substances) (in the presence)
4.	The organization - producer
5.	The name of the legal entity - the applicant of advertizing
6.	Medicine, product of medical appointment, medical equipment are registered in the Republic of Kazakhstan	Registration certificate No. ______________________ date of issue ____________.
7.	Medicine, product of medical appointment has the conclusion about safety and quality, (certificate of conformity)	No., date of issue, the name of the issued organization
7.	Medicine is subject / is not subject to control in the Republic of Kazakhstan
8.	The advertized medicine is released from the pharmaceutical organizations (according to the recipe, without recipe of the doctor)
9.	Advertizing is provided in the state and Russian languages
10.	Content of advertizing in state language is authentic to content of advertizing in Russian
2. Examination of the promotional material on compliance to the requirements established by the legislation of the Republic of Kazakhstan
11.	Advertizing is distinguished without special knowledge or application of special means and shows that the advertized means is medicine, product of medical appointment, medical equipment
12.	Advertizing promotes rational application of the advertized products contains information:
	main indications
	main contraindications
	method of application and doses
	main side effects
	medicinal interactions (for HP of prescription dispensing)
	leave conditions
13.	Advertizing of medicines, products of medical appointment and medical equipment contains information on special instructions, contraindications and side effects in case of application for children, pregnant women and the feeding women
14.	Inadequate advertizing:
14.1	Advertizing is unfair
	contains comparison of the advertized products with products of other physical persons or legal entities
	contains the statements, images discrediting honor, advantage and goodwill of physical persons or legal entities
	misleads consumers concerning the advertized products by means of copying of trade name, the trademark, corporate packaging, external design of goods, formulas, the image and other commercial designation or by means of abuse of their trust
	contains instructions or approvals which use can mislead concerning nature, method of production, properties, suitability to application or goods quantities
	causes assumptions that efficiency of treatment or use advertized by HP, IMN, MT is guaranteed, acceptance or use of the advertized products is not followed by development of side effects
	represents medicine, product of medical appointment and medical equipment as unique, the most effective and safe
	there are comparative characteristics of changes of human body, bodies before application of HP, IMN, MT
	discredits, degrades or derides the faces which are not applying the advertized means
14.2	Advertizing is doubtful there are untrue data at the relation:
	nature, structure, method and date of production, appointment, consumer properties, conditions of use, product quality, certification marks and marks of conformity to state standards, quantities, origins, expiration dates, cost (price)
	official recognition, receipt of medals, prizes, diplomas and other awards
	exclusive rights on the advertized means
	the approvals discrediting activities of other persons
	the status or the level of competence of the producer, the persons implementing and advertizing means
	there are approvals that safety and efficiency of medicine is caused by its natural origin
14.3	Advertizing is unethical:
	contains the text, visual, sound information breaking the commonly accepted regulations of humanity and morals by the use of offensive words, comparisons
14.4	Advertizing is obviously false:
	intentionally misleads the consumer of advertizing
	is followed by the wrong or misleading terms
14.5	Advertizing is hidden:
	makes the impact which is not realized by the consumer on his perception, instincts in video, audioproducts, and also other products, by use of special video inserts, double sound recording and different ways
15.	Availability in advertizing of information prohibited according to the legislation of the Republic of Kazakhstan
	about exclusive or preferential application for children (except the medicines intended for children) \
	information which can lead to wrong self-diagnostics (the description of symptoms of diseases)
	about lack of need of medical consultations or surgeries
	the image of the health pharmaceutical worker, famous persons is used
	mentioning in advertizing for the population of the following diseases: diseases, sexually transmitted, oncological, mental, dangerous infectious diseases, HIV/AIDS, tuberculosis, chronic sleeplessness, diabetes
	contains references to recommendations of scientists, workers of health care, government employees, famous persons
16.	Advertizing contains interlinear information on registration of the advertized means in the Republic of Kazakhstan
17.	Advertizing contains interlinear information on need to study the instruction on medical application or operational documents for medical equipment (the temporary duration of the recommendation in the advertizing extended on TV and radio channels constitutes at least than three seconds, at least 7% of the area of shot)
18.	Advertizing contains interlinear information on permission to advertizing

 

For examination are provided:

1. Statement of the applicant.

2. Advertisement on paper and electronic carriers (the module, Article, storyboard of video records, the text of audio recording) in the state and Russian languages.

3. Advertisement on video, audio recordings in the state and Russian languages in case of distribution on video radio channels.

4. The operational document (in case of provision of advertizing on medical equipment).

During examination are checked:

registration of medicines, products of medical appointment and medical equipment regarding availability in the State register of the Republic of Kazakhstan: registration certificate No. ___________, date ________________;

instruction on medical application;

availability of the conclusion about safety and quality No. _______, date ________________, is issued ______________;

or availability of the certificate of conformity No. _______, date __________________, it is issued ____________________.

Conclusion: The provided promotional materials do not contradict/contradict the legislation of the Republic of Kazakhstan in the field of advertizing.

Based on the carried-out expertize we find possible possible production, distribution, placement, advertizing use

_____________________________________________________________________________________________________________

When conducting examination the following regulatory legal acts of the Republic of Kazakhstan are used:

 

№	Name
1
2
3

 

Are applied to the act of expert evaluation:

1. The conclusion by results of conducting examination of the promotional material.

2. Advertisement on paper in the state and Russian languages (the module, Article, storyboard of video of advertizing, the advertizing text of audio of advertizing) with appendix on electronic media.

3. Advertisement on video, audio recordings in the state and Russian languages in case of distribution on video radio channels.

Appendix 2

to the Order of the Minister of Health of the Republic of Kazakhstan of March 20, 2013 No. 167

The list of invalid some orders in the field of health care of the Republic of Kazakhstan

1) the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 737 "About some questions of issue of permission to advertizing" (registered in the Register of state registration of regulatory legal acts for No. 5931, published in the Collection of acts of the central executive and other central state bodies of the Republic of Kazakhstan, 2010, No. 5; Bulletin of regulatory legal acts of the Republic of Kazakhstan, September, 2010, No. 9, March, 2011 No. 3 of the Art. 398);

2) the order of the Minister of Health of the Republic of Kazakhstan of October 17, 2011 No. 714 "About modification of the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 737 "About some questions of issue of permission to advertizing" (registered in the Register of state registration of regulatory legal acts for No. 7279, published in "The legal newspaper" of December 27, 2011 190 (2180);

3) item 4 of the List of regulatory legal acts of the Ministry of Health of the Republic of Kazakhstan to which changes are made, the Minister of Health of the Republic of Kazakhstan approved by the order of September 28, 2012 No. 664 "About modification of some regulatory legal acts of the Ministry of Health of the Republic of Kazakhstan (registered in the Register of state registration of regulatory legal acts for No. 8081).

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