المملكة: New controls… banning prescription drug advertisements and restricting celebrity advertisements – urgent

In the modernization project, the Authority confirmed that it is prohibited to advertise or advertise pharmaceutical and herbal preparations that are dispensed with a medical prescription except in specialized scientific means, such as magazines, seminars, conferences, and bulletins directed to health practitioners only.

It stressed the need for establishments to adhere to It is responsible for its legal responsibilities when advertising these preparations, and not to use advertising materials after the expiration of the license.

License validity period and renewal mechanism

The advertisement must include the commercial name of the preparation, the name of the active substance, the name and address of the advertising party, in addition to the license number and the quick response code “QR code” clearly without any textual additions, with the exception of visual advertisements such as Video clips on social media platforms, in which it is sufficient to display the advertisement directly without mentioning the license number.

The guide stipulates that the validity of the advertisement approval extends for one year from the date of issuance, and the establishment can extend or renew it for a period not exceeding five years while keeping the same license number, after paying the financial fees due for the entire period.

And in the event of submitting the application From a third party on behalf of the advertising company, a certified authorization must be submitted from the Chamber of Commerce, and the advertising company must be licensed by the Ministry of Information or the General Authority for Media Regulation.

The Authority confirmed that the Arabic language is the primary language in all advertisements, with the possibility of adding other languages provided that they match the Arabic text, and without imposing additional financial fees for supporting languages.

Additions New Regulatory

The new updates to the Advertising Guide for Pharmaceutical and Herbal Preparations included a set of precise regulatory paragraphs aimed at enhancing transparency and discipline in the licensing process and ensuring that establishments adhere to credibility standards.

The Authority obligated establishments to complete the observations within 90 days of being notified that the application was not completed, with the application automatically canceled when exceeded. period without fulfilling the requirements. It also granted the authority the right to object to rejection or cancellation decisions within 30 days, and the opportunity to submit an appeal within an additional 30 days, provided that the decision issued after that is considered final.

The controls also included granting the authority the power to temporarily suspend the license when there are inquiries about the content of the advertisement, provided that the facility bears the responsibility of responding to resume the validity of the license.

The phrase “First “The best-selling”

The instructions exempted establishments from requesting new approval when changing the display method or segmenting the advertising video, provided that they adhere to the same formula and content previously approved.

The updates permitted the use of the phrase “first-selling” provided that the country and year are specified and official proof of this is presented. They also allowed the product to be described as “new” if a full year has not passed since its registration.

It stressed the necessity of submitting a separate application for each different advertising formula, and the necessity of obtaining a license even in the case of advertising only the brand, provided that one product is chosen to represent it.

Preventing the inclusion of electronic links

The authority allowed adding the company’s phone number and means of communication for reporting side effects or quality problems, but it prohibited the inclusion of electronic links or means of communication for inquiries. Medical or requesting information.

Finally, the instructions specified that in the event of advertising on the Instagram platform using the “Slides” feature, the financial fee for all images within one post will be collected only once.

Internet advertisements and social media platforms

The authority clarified that obtaining prior approval is not required to create an official website. For the company, provided that it does not contain any advertising or advertisement for any product.

The site may include patient information leaflets “PIL” and pictures of external containers approved by the Authority for non-prescription products, while information on prescription products is limited to health practitioners only.

With regard to advertisements through individuals and social media celebrities, the Authority stipulated that a An official contract between the establishment or third party and the individual advertiser, keeping a copy of the contract and submitting it upon request for approval.

The contract must include the content of the advertising material, the period of its display, the validity period of the contract, the date of publication, and the display platform, in addition to the advertiser being over 21 years old, with a copy of the “trusted” license issued by the General Authority for Media Regulation attached.

Mechanism Submission

The Authority indicated that submitting the license application is done electronically through the “Unified Platform for Services of the Food and Drug Authority” through its website, by choosing the “Medicine” classification and then the “Issuing a Drug Advertising License” service, where establishments can submit applications and complete the documents electronically in an integrated manner.

The “Food and Drug Administration” confirmed that this update comes within its efforts. Continuing to regulate the pharmaceutical and herbal advertising market in the Kingdom, and ensuring that all advertisements are based on scientific foundations and accurate, officially approved information, in order to achieve consumer protection and support ethical practices in pharmaceutical marketing.