المملكة: Not misleading or contrary to Sharia law.. 20 conditions for approval of medical device advertising
The Authority required obtaining the Authority’s approval of the format of the promotional or advertising material for medical devices and supplies before publishing it, whether it is directed to ordinary users or health practitioners.
The Authority stressed the need for advertising not to contain any misleading information to the user that contradicts the claims specified by the manufacturer, and not to contain some phrases that could be interpreted incorrectly, stressing avoiding misleading the ordinary user in advertising and advertising materials and publications directed to the community, including information on the Internet. “Internet.”
It requires that promotional and advertising materials and publications directed to people concerned with using medical devices and supplies contain information compatible with their needs, and that people concerned with marketing medical devices and supplies must have sufficient information about them to ensure the provision of correct information regarding their marketing.
The obligations also include that the propaganda and advertisements do not directly or indirectly harm any device or other medical supplies, and that they do not contain comparisons with the products of other competing companies, and that the language used in the propaganda and advertisements is the Arabic language if it is directed to the average user, and the English language if it is directed to the average user. It was directed to health practitioners, and other languages may be used provided that they match the language to be used in the advertisement, provided that the needs of persons with disabilities are taken into account.
The requirements included that the propaganda and advertising should not contain claims that are not approved by the authority, and that the name or logo of the authority should not be used directly or indirectly in the content of the propaganda and advertisement or any name or logo of another regulatory body, whether internal or external, and that the advertising and promotional material should not be in violation of the law. “Publications and Publishing”, obtaining the required approvals and licenses from the competent authorities and adhering to the requirements and instructions of other relevant relevant authorities in the event of holding introductory lectures or seminars about the device. Or medical supplies, whether in person or remotely, whether visual or audible.
The regulations permit the establishment to authorize an advertising agency licensed by the competent authority to submit an application on its behalf to obtain approval for advertising, provided that the authorization is certified by the Chamber of Commerce.
It obliges the applicant for approval for advertising to obtain the facility number in the system, and a facility license for medical devices and supplies. When the application is submitted by a health care provider, the facility number must be obtained in the system, stressing that the advertising and advertising material must include the name of the device or medical supply. The name or brand of the manufacturer.
In the event that approval is requested for advertising a medical device and its accessories or more than one device or medical device combined into one marketing authorization application, the financial fee will be paid once, and in the case of advertising and advertising an accessory to a device without the main device, the financial fee must be paid for the approval request. Advertising.
Objection to the cancellation within 30 days
She explained that if the application for an advertising license is rejected or a decision is issued to cancel the advertisement by the Authority, the establishment submitting the application has the right to object to the decision within 30 days from the date of issuance of the decision.
The Authority has the right to suspend the approved advertisement request in the event that there are inquiries about the content of the advertisement, and the facility bears the responsibility of responding to these inquiries to restore the advertisement license.
The Authority holds the manufacturers and authorized representatives responsible for ensuring that all advertising and advertising materials for their medical devices and supplies have been approved by the Authority before using them, and for providing distributors and importers – if any – with a copy of all advertising and promotional materials that have been approved, specifying the target recipient. Either “ordinary users” or “health practitioners”.
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