Unofficial translation
In accordance with paragraph 1 of Article 56 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On people's health and health care system" I HEREBY ORDER:
1. To approve the attached rules for advertising of medicines and medical products.
2. To declare invalid:
1) Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated February 27, 2015 No. 105 "On approval of the Rules for advertising of medicines and medical products" (registered in the Register of state registration of regulatory legal acts under No. 10667, published on April 17, 2015 in the information and legal system "Adilet");
2) paragraph 2 of the List of orders in the field of health care, which are amended, approved by the order of the Minister of Health of the Republic of Kazakhstan dated April 22, 2019 No. ҚР ДСМ -44 "On 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" (registered in the Register of state registration of regulatory legal acts under No. 18582, published on May 2, 2019 in the Reference Control Bank of regulatory legal acts of the Republic of Kazakhstan).
3. The Committee for Control of Quality and Safety of Goods and Services of the Ministry of Health of the Republic of Kazakhstan, in the manner prescribed by the legislation of the Republic of Kazakhstan, to ensure:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) posting this order on the Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
3) within ten working days after the state registration of this order in the Ministry of Justice of the Republic of Kazakhstan, submission of information to the Legal Department of the Ministry of Health of the Republic of Kazakhstan on implementation of the measures provided for in subparagraphs 1) and 2) of this paragraph.
4. The supervising vice minister of health of the Republic of Kazakhstan is authorized to control the execution of this order.
5. This order comes into force upon the expiration of ten calendar days after the day of its first official publication.
|
Minister of health of the Republic of Kazakhstan |
A. Tsoi |
| Approved by the order of the Minister of health of the Republic of Kazakhstan dated December 20, 2020 № ҚР ДСМ-288/2020 |
Rules for advertising of medicines and medical products
Chapter 1. General provisions
1. These rules for advertising of medicines and medical products (hereinafter referred to as the Rules) are developed in accordance with Article 56 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On people's health and health care system" (hereinafter referred to as the Code), as well as the Law of the Republic of Kazakhstan dated December 19, 2003 "On advertising" and determine the procedure for advertising of medicines and medical products.
2. The following terms and definitions are used in these Rules:
1) advertising of medicines and medical products (hereinafter - advertising) - information disseminated and (or) placed in any form, using any means, intended for an indefinite group of persons, containing individual information or a set of information about medicines and medical products, contributing to their promotion and implementation;
2) scientific information material - information or a set of information about a medicine and a medical product containing scientific and analytical data, disseminated in the form of scientific articles, guidelines, teaching aids;
3) applicant - an individual or legal entity (organization - manufacturer, distributor, representative office) or their authorized representative authorized to submit an application, documents and materials for assessment of advertising materials for medicines and medical products;
4) advertising material - documents and materials used in the assessment of advertising of medicines and medical products for compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare, received from the applicant;
5) advertising module - a text and graphic message of an advertising nature about medicines and medical products, made on paper (booklet, leaflet, etc.) and distributed in health care organizations and (or) placed in print media;
6) advertising article - an informational article containing an advertisement for a medicine and a medical device;
7) advertising audio - an audio product of an advertising nature about medicines and medical products posted on radio and Internet resources;
8) advertising banner - one or a series of text and graphic images of an advertising nature about medicines and medical products, posted on Internet resources;
9) advertising video - an audiovisual work of an advertising nature about medicines and medical products posted on television channels and Internet resources;
10) storyboard - a sequence of drawings that serve as an auxiliary tool for creating videos and advertising banners;
11) advertising distributor - an individual or legal entity that distributes and places advertising information by providing and (or) using property, including technical means of television and radio broadcasting and in other ways;
12) state expert organization in the field of circulation of medicines and medical products (hereinafter referred to as the expert organization) - an organization determined by the authorized body in the field of healthcare to assess advertising materials for medicines and medical products for compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare.
Chapter 2. Procedure for advertising of medicines and medical products
3. Distribution and placement of advertising of medicines and medical products is carried out in the media, electronic information resources in healthcare organizations.
4. Advertising is provided in the Kazakh and Russian languages and contains complete and reliable information about the medicine or medical product, contributing to their rational use.
5. Advertising corresponds to the instructions for medical use of the medical product (leaflet), instructions for medical use or operational document for the medical product.
When changes are made to the instructions for medical use of a medicine and medical product that affect the content of advertisements distributed, the changes are reflected in the advertising materials.
6. Advertising does not exaggerate the pharmacological properties and therapeutic indications of the advertised medicine, the field of application for medical products, and also excludes comparisons with other medicines and medical products.
Advertising does not mislead consumers through abuse of their trust, including in relation to characteristics, composition, consumer properties, cost (price), intended results of use, research and test results.
The advertisement is easy to read, printed in a clear and legible font, is reliable and recognizable (no special knowledge or the use of special tools).
7. Advertising of medicines contains the following information:
1) trade name;
2) international non-proprietary name or information about the active ingredients included in the composition;
3) the main indications for use;
4) method of administration and dose;
5) the main side effects;
6) main contraindications;
7) special instructions for use by children, pregnant women, as well as during breastfeeding (if any);
8) release conditions;
9) a clear and understandable recommendation before prescribing and using, carefully read the instructions for medical use and the text of the warning with the following content “Self-medication can be harmful to your health;
10) name, address of the manufacturer and (or) sales representative in the Republic of Kazakhstan;
11) the number and date of issue of the registration certificate;
12) the expiration date of the registration period.
Advertising intended for TV channels and Internet resources contains the information specified in subparagraphs 1), 3), 7), 9), 11), 12), for radio channels the information specified in subparagraphs 1), 3), 7), 9 ) of this paragraph.
8. Advertising of medical products contains the following information:
1) trade name;
2) the main indications for use (scope);
3) main side effects (if any);
4) main contraindications (if any);
5) a clear and understandable recommendation before prescribing and using, carefully read the instructions for medical use (operational document) of the medical product and the text of the warning with the following content “Self-medication may be harmful to your health” (as applicable);
6) name, address of the manufacturer and (or) the authorized representative in the Republic of Kazakhstan;
7) number and date of issue of the registration certificate;
8) the expiration date of the registration period.
Advertising intended for TV channels, Internet resources contains the information specified in subparagraphs 1), 2), 5), 6), 7), 8), for radio channels the information specified in subparagraphs 1), 2), 5), 6 ) of this paragraph.
9. Advertising of medicines and medical products does not include:
1) information related to human health or diseases;
2) instructions for medical use, trade catalogs, price lists, reference materials, scientific information material, methodological and educational materials of a medical nature;
3) information about an individual and (or) legal entity that manufactures or sells a medicine and (or) a medical product;
4) a logo, trade and (or) international non-proprietary name applied to industrial products distributed among medical and pharmaceutical workers (pens, notebooks, bags, medical gowns, calendars, business card holders, flash drives, etc.).
10. Advertising of medicines and medical products is prohibited in the cases provided for by paragraph 3 of Article 56 of the Code.
11. An advertising distributor places an advertisement when the applicant submits a conclusion of an expert organization on the compliance of advertising with the legislation of the Republic of Kazakhstan in the field of healthcare.
12. To obtain a conclusion on the compliance of advertising with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare, an applicant concludes an agreement with an expert organization on assessment of advertising materials for medicines and medical products and submits the following documents and materials to the Applicant Service Center (hereinafter - ASC) of the expert organization:
1) an application in the form in accordance with Appendix 1 to these Rules;
2) advertising material in paper and electronic media in the Kazakh and Russian languages (module, article, storyboard of video advertising or banner, advertising text of audio advertising);
3) video and audio recordings of advertisements in the Kazakh and Russian languages when distributed on video and radio channels;
4) operational document of a medical product (in the case of advertising for medical products);
5) information confirming the payment by the applicant to the settlement account of the expert organization of the amount for assessment of advertising materials for medicines and medical products.
Payment for the assessment of advertising materials for medicines and medical products is made by the applicant in accordance with the price list approved by the expert organization.
13. The responsible executor of the ASC, after receiving the documents specified in paragraph 12 of these Rules, within one working day, registers the application and enters the information into the information system.
14. The expert organization, after accepting and registering the application, within 10 working days, checks the completeness of the submitted documents and materials and evaluates advertising materials for medicines and medical devices for compliance with the requirements of the legislation of the Republic of Kazakhstan and these Rules.
15. In case of revealing in the submitted documents and materials inconsistencies with the requirements provided for in Article 56 of the Code and paragraphs 5-8 of these Rules, detection of inaccurate data (information), the expert organization sends the applicant a single letter indicating the identified comments and the need to eliminate them in full in time, not exceeding 10 working days from the date of receipt of the letter from the expert organization.
16. The term for the applicant's elimination of comments is not included in the general term for the assessment of advertising materials for medicines and medical products provided for in paragraph 14 of these Rules.
17. If the applicant does not provide a response to the letter of the expert organization or does not eliminate the comments made within the established time frame, the expert organization sends the applicant a reasoned refusal to assess the advertising materials of medicines and medical products.
In cases of a reasoned refusal based on the results of the assessment of advertising materials for medicines and medical products or the applicant's withdrawal of an application for an assessment of advertising materials for medicines and medical products after the start of the assessment of advertising materials for medicines and medical products by an expert organization, the cost of the work is not returned to the applicant.
18. The result of the assessment of advertising materials for medicines and medical products is drawn up by an act of expert assessment of advertising materials for medicines and medical products for compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare in the form in accordance with Appendix 2 to these Rules (hereinafter - the act).
19. On the basis of the act, the applicant is issued a Conclusion on compliance of advertising of medicines with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare in the form according to Appendix 3 or a Conclusion on compliance of advertising of medical products with the requirements of the legislation of the Republic of Kazakhstan in the field of health care in the form according to Appendix 4 to these Rules or a reasoned refusal in a written form.
Upon completion of the assessment of advertising materials for medicines and medical products, the expert organization returns the advertising information to the applicant in hard copy in the Kazakh and Russian languages (module, article, storyboard of video advertising or banner, advertising text of audio advertising) with the stamp of the expert organization “Assessment for compliance with legislation of the Republic of Kazakhstan" with the indication of the number and date of the expert assessment act and the signature of the person who assessed the advertising materials for medicines and medical products.
| Appendix 1 to the Rules for advertising of medicines and medical products |
|
| Form |
Application
Applicant: ______________________________________________________
legal address: ___________________________________________________
telephone: ______________________________________________________
fax: ___________________________________________________________
applicant's email address: __________________________________________
Applicant's representative __________________________________________
(Full name (if any), position, power of attorney is attached)
telephone _______________________________________________________
fax ____________________________________________________________
E-mail address ___________________________________________________
We hereby request _______________________________________________
(full name of the state expert organization)
To assess advertising materials for a medicine, medical
products (underline necessary) for compliance with the legislation of the Republic
Kazakhstan in the field of healthcare.
trade name ___________________________________________
international non-proprietary name (if any) __________________
dosage form, dosage, packaging
(for a medicine) ____________________________________________________
release conditions (for a medicine) ______________________ at that
we inform you that the specified medicine, medical product (required
underline) is registered in the Republic of Kazakhstan.
Registration certificate No. ______ "____" ______ _____ year.
Medicine, medical product passed quality assessment in the Republic of
Kazakhstan.
Certificate of Conformity No. ___, date ___, issued _______ name of the
organization.
We attach to the application: advertising on paper in the Kazakh and Russian
languages (module, article, storyboard of video ad or banner, ad text of
audio ads) and on electronic media in PDF format in the Kazakh and Russian languages
(underline necessary); video, audio-recording of advertising in the Kazakh and Russian languages
when placing advertisements on television channels and radio (underline the necessary).
№ | Subject that made payment | |
1. | Name | |
3. | Legal address | |
4. | Actual address | |
5. | Full name (if any), position | |
6. | Phone number | |
7. | Fax | |
8. | ||
9. | BIN | |
10. | IIN | |
11. | Bank | |
12. | Settlement account | |
13. | Currency account | |
14. | Code | |
15. | BIC |
Applicant ________________________________ clarification of signature
(personal signature)
| Appendix 2 to the Rules of advertising of medicines and medical products |
|
| Form |
Act of expert assessment of advertising materials for medicines and medical products for compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare
| dated "___"_______ ___ . №_____ |
№ | Requirements for advertising | Compliance with the requirements in the information provided |
1. General information | ||
1. | Trade name | |
2. | International non-proprietary name or composition (if any) | |
3. | Release form, dosage of active substance (substances) (if any) | |
4. | Manufacturing organization | |
5. | Advertising applicant name | |
6. | Medicine, medical products are registered in the Republic of Kazakhstan | Registration certificate No. ___ date of issue ____ |
7. | Medicine, medical products have a certificate of conformity | No., date of issue, name of issuing organization |
8. | Medicine is (is not) subject to control in the Republic of Kazakhstan | |
9. | The advertised medicine is released from pharmacy organizations (by prescription, without a doctor's prescription) | |
10. | Advertising is presented in the Kazakh and Russian languages | |
11. | The content of advertising in the Kazakh language is authentic to the content of advertising in Russian | |
2. Assessment of advertising material for compliance with the requirements established by the legislation of the Republic of Kazakhstan | ||
12. | Advertising is recognized without special knowledge or the use of special means and shows that the advertised product is a medicine, medical product | |
13. |
Advertising promotes the rational use of the advertised products | |
basic indications | ||
main contraindications | ||
method of administration and dose | ||
main side effects | ||
drug interactions (for prescription drugs) | ||
14. | Advertising of medicines, medical product contains information on special instructions, contraindications and side effects when used for children, pregnant and lactating women | |
15. | Inappropriate advertising: | |
15.1 | Advertising is unfair | |
contains a comparison of the advertised products with the products of other individuals or legal entities | ||
contains statements, images that defame the honor, dignity and business reputation of individuals or legal entities | ||
misleads consumers about the advertised products by copying the brand name, trademark, brand packaging, external design of another manufacturer's product, formulas, images and other commercial designation, or by abuse of their trust | ||
contains indications or statements, the use of which is misleading about the nature, method of manufacture, properties, suitability for use or quantity of goods | ||
suggests that the effectiveness of treatment or use of the advertised medicines and medical products is guaranteed, the intake or use of the advertised products is not accompanied by the development of side effects | ||
presents a medicine, a medical product as a unique, most effective and safe | ||
there are comparative characteristics of changes in the human body, organs before and after the use of medicines and medical products | ||
discredits, humiliates or ridicules persons who do not use the advertised means | ||
15.2 | Advertising is unreliable there are false information regarding: | |
nature, composition, method and date of manufacture, purpose, consumer properties, conditions of use, product quality, certification marks and marks of compliance with state standards, quantity, origin, shelf life, cost (price) | ||
official recognition, receiving medals, prizes, diplomas and other awards | ||
exclusive rights to the advertised product | ||
statements that discredit the activities of others | ||
the status or level of competence of the manufacturer, persons selling and advertising the product | ||
there are claims that the safety and effectiveness of medicines is due to its natural origin | ||
15.3 | Advertising is unethical: | |
contains text, visual, sound information that violates generally accepted norms of humanity and morality by using offensive words, comparisons | ||
15.4 | Advertising is known to be false: | |
deliberately misleads the advertising consumer | ||
accompanied by incorrect or misleading terms | ||
15.5 | Advertising is hidden: | |
has an unconscious effect on the consumer's perception, instincts in video, audio, and other products, through the use of special video inserts, double sound recording and in other ways | ||
16. | presence in advertising of information prohibited in accordance with the legislation of the Republic of Kazakhstan | |
16.1 | on the exclusive or preferential use for children (except for medicines intended for children) | |
16.2 | information leading to erroneous self-diagnosis (description of disease symptoms) | |
16.3 | no need for medical advice or surgery | |
16.4 | using the image of a medical, pharmaceutical worker, famous persons | |
16.5 | mention of sexually transmitted diseases, oncological, mental, dangerous infectious diseases, HIV, tuberculosis, chronic insomnia, diabetes mellitus in advertising for the population | |
16.6 | mention of alcohol and tobacco smoking in advertising to the public | |
16.7 | contains links to recommendations from scientists, healthcare professionals, government officials, famous people | |
17. | advertisement contains subscript information on the registration of the advertised product in the Republic of Kazakhstan | |
18. | advertisement contains interlinear information about the need to study the instructions for medical use or operational documents for medical products (the temporary duration of a recommendation in an advertisement distributed on television and radio channels is at least three seconds, at least 7% of the frame area) | |
Conclusion: The presented advertising materials correspond
(do not correspond) to the legislation of the Republic of Kazakhstan in the field of healthcare.
We consider it possible (impossible) to make advertising (in the media)
Attached to the act:
1. Advertising on paper in the Kazakh and Russian languages (module, article,
storyboard of video ad or banner, audio of ad text) and on electronic carriers.
2. Video, audio-recording of advertising in the Kazakh and Russian languages when distributed to
TV and radio channels.
3. Conclusion on compliance of advertising of medicines, medical products with
the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare or
a motivated refusal in writing.
Position, personal signature and clarification of signature of the person who assessed the
advertising materials.
| Appendix 3 to the Rules of advertising of medicines and medical products |
|
| Form |
Conclusion on compliance of advertising of medicines with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare
The expert organization reports the results of assessment of the advertising material of medicine for compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare
№ | Trade name of the medicine (indicating the dosage form, dosage, concentration and volume of filling, the number of doses in the package - for the medicinal product) | International non-proprietary name (INN) | Organization-manufacturer, country of origin | Registration certificate number, date, validity period | Certificate of conformity (number, date, issued by) | Advertising material presented | |
(module, banner, article, video material, audio material) | number of pages, video sec., audio sec. | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
Conclusion:
___________________________________________________________________
Appendix advertising
__________________________________________________________________
(module, article, storyboard of video advertising or banner, text of audio advertising on paper, audio and video recordings on electronic media)
The presented advertising materials do not contradict the legislation of the Republic of Kazakhstan in the field of healthcare, we consider it possible to carry out advertising.
___________________________________________________________________
(in the media)
Position, personal signature and clarification of the signature of the head of the expert organization
____________________________________________
Date _____________
| Appendix 4 to the Rules of advertising of medicines and medical products |
|
| Form |
Conclusion on compliance of advertising of a medical product with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare
The expert organization reports the results of assessment of the advertising material of a medical product for compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare
№ | Trade name of a medical product | Organization-manufacturer, country of origin | Registration certificate number, date, validity period | Certificate of conformity (number, date, issued by) | Advertising material presented | |
(module, banner, article, video material, audio material) | number of pages, video sec., audio sec. | |||||
1 | 2 | 3 | 4 | 5 | 6 | 7 |
Conclusion: _______________________________________________________
Appendix advertising
__________________________________________________________________
(module, article, storyboard of video advertising or banner, text of audio advertising on paper, audio and video recordings on electronic media)
The presented advertising materials do not contradict the legislation of the Republic of Kazakhstan in the field of healthcare, we consider it possible to carry out advertising
__________________________________________________________________
(in the media)
Position, personal signature and clarification of the signature of the head of the expert organization
_________________________________________________________________
Date __________
