The Minister of Healthcare of the Republic of Kazakhstan has issued an Order implementing the new advertising rules for medicines and medical devices. The new advertising rules are based on the Code of the Republic of Kazakhstan “On public health and healthcare system” dated July 7, 2020. It also replaces several regulations that governed the respective aspects before. According to the official notice, the new rules take effect in 10 business days from the date of state registration of the appropriate Order by the Ministry of Justice of the Republic of Kazakhstan.
Besides the aforementioned code, the new advertising rules are also based on the Law of the Republic of Kazakhstan “On advertising” dated December 19, 2003. The rules are intended to govern the procedures related to the advertising of medicines and medical devices allowed to be marketed in Kazakhstan.
The new rules provide the definitions of the most important terms, such as:
- Advertisement of medicines and medical devices (hereinafter – the advertisement) – information distributed or placed in any form, by other means, aimed at an indefinite audience, containing certain details on medicines and medical devices, facilitating their promotion and distribution;
- Scientific-informational material – information about medicines and medical devices, containing scientific and analytical data, distributed in the form of scientific articles, methodical recommendations, or educational guides;
- Applicant – natural or legal person (organization – manufacturer, distributor) or their authorized representative, entitled to submit the application, documents, and materials on the assessment of advertising materials on medicines and medical devices;
- Advertising materials – documents and materials, used when conducting the assessment of advertising for medicines and medical devices with regard to compliance with the applicable laws and regulations.
Aside from the aforementioned terms, the new rules also provide such definitions as advertising module, advertising article, advertising audio, advertising banner, advertising video, publisher, and also the state expert organization in the sphere of medicines and medical devices.
Medical Device Advertising Rules and Procedures
The new rules describe in detail the procedures for the design and placement of advertising for medical devices to be followed by the interested parties. According to the new rules, advertising should be issued in Kazakh and Russian languages and contain full and reliable information about medicines or medical devices facilitating their use in the correct way. The advertising shall meet the information indicated in the instructions for use accompanying the medical device or user documentation. Moreover, in case of the changes to the instructions for use of a medical device impacting the information indicated in the advertisement, the appropriate changes should be made to the advertising materials as well.
The document also provides the following rules:
- An advertisement shall neither expand the actual scope of application of medical device nor contain comparison to other medical devices,
- An advertisement shall not misinform the customers with regard to the characteristics, functions, features, composition, expected use results, as well as the results of examination or trials, or price of the medical device,
- An advertisement should be easily readable and printed in a clear font, be accurate and recognizable (without special knowledge or means).
In accordance with the regulation, an advertisement of a medical device shall contain the following information:
- Trade name,
- Indications for use (sphere of application),
- Main side effects (if applicable),
- Main contradictions (if applicable),
- Clear and understandable recommendation to read the instructions for use before using the device, as well as the warning: “Self-treatment could be harmful to your health” (if applicable),
- Name, address of the medical device manufacturer and/or its authorized representative in the Republic of Kazakhstan,
- Number and date of issue of the registration certificate,
- Date of expiration of the registration.
At the same time, some types of informational materials do not constitute an advertisement. For instance, the information related to the health of people, instructions for use, trade catalogs, prices, methodical recommendations, information about the medical device manufacturer or distributor, logo, trade, or international name shall not be deemed as an advertisement.
According to the new rules, the publisher may publish an advertisement related to a medical device only in case the applicant would provide the appropriate permit issued by the expert organization, indicating that the advertisement in question meets the requirements set forth by the applicable legislation. In order to obtain such permission, an applicant shall enter into an agreement with the expert organization to conduct the assessment of advertising materials prior to publication. When applying for a permit, an applicant shall submit the following documents:
- The application form,
- Advertising materials in paper and electronic form in Kazakh and Russian languages (module, article, banner, etc.),
- Video or audio recording intended for further distribution,
- Operating documentation for a medical device,
- Proof of payment.
The application will be registered within one business day from the date of submission, while the actual assessment of the application takes up to 10 business days from the date of registration. In case of any non-compliances identified, the applicant shall make necessary changes no later than 10 business days from the date the appropriate request was communicated by the regulating authority. However, this period would not be included in the calculation of the overall review period. Should the applicant fail to provide the documents requested or eliminate the non-compliances identified, an expert organization would provide a motivated refusal. In such a case, the fee paid by the applicant for the review would not be refunded.
The results of the assessment of advertising materials would be indicated in the appropriate action. On the basis of such an act, the expert organization issues either a conclusion confirming compliance with the applicable requirements (permission to publish the advertisement) or a motivated refusal. Upon completion of the assessment, the advertising materials submitted for review would be returned to the applicant with the stamp of an expert organization and indication of the number and date of the respective act, signed by the authorized person of the expert organization.
Application For Permission
The new rules on advertising for medical devices also introduce the appropriate templates of the documents to be used by both the applicants and examination organizations. For instance, the rules contain the templates of the application for review of the advertising materials to be submitted by the medical device manufacturer, its authorized representative, or distributor when applying for permission to publish the advertisement. Additionally, the rules contain a template of an act to be issued by an expert organization upon completion of the review, as well as the template of the appropriate conclusion on compliance of the advertising materials with the applicable requirements set forth by the legislation of the Republic of Kazakhstan, which actually constitutes permission to publish the advertising materials and use them for promotional purposes.
Summarizing the information provided here above, the new rules on advertising of medicines and medical devices govern the relationships arising with regard to advertising activities related to medical devices allowed to be marketed in the Republic of Kazakhstan. The rules set forth the detailed requirements regarding the design of advertising materials and the information they should contain. The rules also set forth the procedure to be followed by an interested party when applying for permission to publish the advertising materials.
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