Pharmaceutical advertising regulation and medical device advertising in Saudi Arabia

1.1  Medicines 

In general, the Implementing Regulations of Pharmaceutical and Herbal Establishments and Products Law dated 22/3/1442 H corresponding to 8 November 2020 (the “ Regulations”) briefly address advertisements of prescriptive and non-prescriptive medicines. 

The Guide for the Rules and Procedures for the Marketing Advertising Pharmaceutical and Herbal Products dated 20 October 2022 (the “Guide”) deal with the advertisement and marketing of (i) pharmaceutical products, and (ii) herbal products and (iii) non-prescriptive health products. 

1.2 Medical devices 

Medical devices in KSA are subject to:

• Medical Devices and Products Law(the “Medical Devices Law”)
• The Implementing Regulations of the Medical Devices and Products Law (the “Medical Devices Regulations”)
• MDS—REQ8 Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical Devices dated 15 June 2022 (the “Requirements”)  issued by the Saudi Food and Drug Authority(“ SFDA”). 

The Saudi Code of Pharmaceutical Promotional Practices in KSA (“Code”) largely addresses the relation between pharmaceutical companies and manufacturers on the one hand and health practitioners on the other. The Code discusses the promotion of pharmaceutical products generally, regardless of whether such products are prescriptive or over the counter. 

The Code is an ethical code for practicing pharmaceutical promotion. All pharmaceutical companies, pharmaceutical manufacturers working in KSA and in the health sector, physicians, health practitioners, and pharmacists either working in the private or public sectors should adhere to this Code. 

The Code provides that the advertisement or promotion of pharmaceutical products in general should be based on accurate, up to-date, balanced and non-biased information. The Code further requires that such information to be based on measurable controls and standards. 

The Code further provides that a pharmaceutical product must not be promoted for sale or supply before obtaining a marketing authorization licence for such product and all advertising and that the promotional materials for a pharmaceutical product must be approved and certified by the SFDA.

For medicines, the Guide provides that approval of the SFDA should be sought prior to any advertisement of pharmaceutical products is made to the general public. Likewise, the Code provides that a marketing authorisation should be sought before promoting pharmaceutical products, and that the promotional materials should be in line with the usage as approved by the SFDA. It is worth noting that as a pre-requisite to seeking SFDA’s approval for advertising pharmaceutical products, the medicines must be listed with the SFDA. The Guide prohibits the advertisement of non-listed pharmaceutical products. 

With regards to the advertisement of medicines to the general public, the Guide provides that there is a non- refundable fee payable to the SFDA for seeking approval for the underlying advertisements to the general public equal to SAR 14,000. 

There is also a new category of approvals by the SFDA for advertising pharmaceutical products by influencers on social media platforms. The fees for this of approval SAR 14,000 per advertisement. 

As for advertisements for pharmaceutical products which are targeted to health practitioners, the SFDA does not impose any fees and does not require any approvals so long as the advertisement complies with the specific requirements as listed in the Guide. 

It must be distinguished that the resale, lending, or donation of medical devices requires a Medical Devices Marketing Approval (“MDMA”) from the SFDA which requires the submission of all marketing and advertising materials to the SFDA as part of the application. The fees for the MDMA differ per medical device. On the other hand, the advertising of medical devices requires an Approval of Medical Device Advertisement (“ AMDA”) which can be obtained from the SFDA for a fee of SAR 3,000 for advertisements to the general public and a fee of SAR 6,000 for advertisements to health practitioners.

Yes, the advertising and marketing of prescription-only and over-the-counter medicines is regulated differently in the KSA. The advertisement of prescriptive medicine is prohibited under Article 36 of the Regulations, with the exception of advertisement in scientific  publications, conferences and workshops which are directed to medical practitioners. Article 36 further provides that non-pharmaceutical and herbal products may only be advertised after the approval of the SFDA. 

The Code deals with promotion and advertisement in the context of medical practitioners and covers pharmaceutical products generally whereas the Guide specifically deal with the advertisement and marketing of (i) non-prescriptive pharmaceutical products and (ii) herbal products.  

Further, the Guide clarifies at the outset that advertising may only be carried out for non-prescriptive products. Such restrictions only apply to advertisements targeted at the general public. The advertisements of prescriptive medicine targeting health practitioners is permitted.  

5.1 Medicines 

As per the Guide, the following are some of the restrictions and controls applicable on the advertisement of non-prescriptive pharmaceutical products to the general public:

• Only non-prescriptive products can be advertised.
• The product should be listed with the SFDA.
• Advertisements should not contain claims which are not certified by the SFDA.
• Advertisements should comply with the social values and should not violate public decency.
• Advertisements should not contain statements which demean other products.
• Advertisements should not provide incorrect or misleading information, or information that is unclear and that is susceptible to inappropriate interpretation. 

5.2 Medical devices 

The Requirements provide for restrictions applicable to the advertising of medical devices, including the following:

• The medical device must be licensed form the SFDA and bear an MDMA.
• All advertisement material must be approved by the SFDA.
• The advertising material must not mislead the user regarding the performance of the medical device as specified by the manufacturer.
• The advertising to the general public, including on the internet, must avoid misleading lay persons.
• Any advertising to persons qualified to use medical devices must include the relevant information compatible with their specific needs.
• Medical devices sales representatives must have sufficient knowledge to be able to provide appropriate information about the medical devices they promote.
• The advertisement must be in Arabic.

As per the Guide, below are some of the restrictions and controls on promotion of pharmaceutical products: 

• The record of any advertisements to health practitioners must be retained for three years.
• The advertisement must be in English.
• The information in the advertisement must fairly balanced and shall include information about the effectiveness, safety, and side effects of using the product.
• Advertisements to health practitioners are restricted to scientific journals and conferences. 

As for the restrictions on the advertisement of medical devices to health practitioners, the Requirements stipulate many restrictions such as the following:

• The medical device must be licensed form the SFDA and bear an MDMA.
• All advertisement material must be approved by the SFDA.
• Any advertising to persons qualified to use medical devices must include the relevant information compatible with their specific needs.
• Medical devices sales representatives must have sufficient knowledge to be able to provide appropriate information about the medical devices they promote.
• The advertisement must be in English. 

7.1 Medicines

With regard to the medicines, the Code provides that the promotional material of pharmaceutical products should include, among other things, the following:  

• Trade name of the product;
• The scientific name of the products;
• Name and address of the company/agent responsible for marketing;
• Scenitifc reference for the advertised information; and
• Dosage, side effects, precautions and method of use

7.2 Medical devices 

As regards the medical devices, the Requirements do not distinguish advertisements directed to the general public and health professionals. 

The Requirements provide that the advertising and marketing material must: 

• include the relevant information compatible with professional specific needs, when advertising to professionals.
• include the following:
  • name of device;
  • name and address of manufacturer;
  • document control reference number (it is required in case of as part of MDMA procedure).
• medical devices advertising licence number (it is required in case of separate approval).
• not include the SFDA logo nor the establishment National Registry Number, that is issued through SFDA’s MDNR, but may include the Medical Device National Listing Number issued through SFDA’s MDMA.
• not include phrases that might be misinterpreted.
• not violate the Saudi law of “Printed Materials and Publication”.
• the advertising and marketing material must be in English, where it is intended for professionals, but for the general public it should be in Arabic. 

8.1 Medicines

As per the Guide, the following are some of the information which must appear in the advertisements for non- prescriptive pharmaceutical products to the general public:

• The approval number of the SFDA;
• The trade name of the product and the active ingredients;
• The statement: “this product has several side effects, for more information please consult a doctor or a pharmacist and read the information leaflet”.

Certain statements are to be included in advertisements depending on the nature of the product being advertised. 

8.2 Medical devices 

Please see response in 7.2.

The Guide provides that the content of advertisements of non-prescriptive products should be in line with the patient information leaflet as well as the summary of product characteristics.

The Code further provides that any medical claim should be supported by scientific reference. Scientific studies and references should be clearly reproduced leaving no room for misinterpretation. 

For medical devices, the SFDA requires, among other things, the information about the relevant medical device along with the scientific supporting documents or evidence with reference for any medical claim. 

There are no specific rules for comparative advertisement of medicines and/or medical devices except that the Guide provides that advertisements for non-prescriptive pharmaceutical products should not harm the reputation of other products or provide incorrect information. 

The Code provides that any comparison between different pharmaceutical products should be based on comparison points that are relevant to the product and to be for statistical purposes. The advertising and comparison should not be misleading or give a dishonest impression about the other products.  

The Guide provides that online advertisements for non-prescriptive pharmaceutical products should be available on the webpage provided by the applicant, and should not redirect visitors to other websites. It is further provides that online advertisements should not include information about medical practitioners. 

With regards to the medical devices, the Requirements provide that the advertising and marketing material must avoid misleading the general public, when advertising to the general public, including advertisements on the internet.

As for social media, the SFDA approval for any advertisement must be obtained at least 12 hours before the advertisement is posted. Moreover, the restrictions include among other things, that the social media influencer holds a Mawthooq license and be above 21 years old, it also requires providing the SFDA with the advertising contract with the influencer which should contain among other things the date and time of publishing the advertisement by the influencer and the specific social media platform(s) which will publish the advertisement. 

As regards the advertisement of medicines, no enforcement mechanism is provided in the Guide regarding the failure to comply therewith when advertising to the general public. However, Article 35 of the Regulations provides that the SFDA may impose the following penalties in respect of violations of the Regulations: 

• A fine not exceeding SAR 5,000,000/-;
• Closure of the medical establishment temporarily for up to 180 days;
• Revoking the licence.

For medical devices, as per Article 42 of the Medical Devices Regulations the SFDA is fully authorised to ensure compliance with the advertisement provisions, failing which the SFDA may withdraw or restrict the medical devices including taking any of the following actions:

• A fine not exceeding SAR 5,000,000;
• Temporary closure of the pharmaceutical establishment for up to 180 days; and/or
• Recalling the product from the market;
• Revoking the MDMA;
• Revoking the license.

The SFDA releases from time to time various draft rules and regulations for public commentary before these drafts become effective. Currently, we are not aware of any future developments that may affect the responses above.

Footnote: Issued by Saudi Food and Drug Authority Board of Directors Decree Number (1-8-1429) and dated 27 December 2008, and amended by Saudi Food and Drug Authority Board of Directors Decree Number (4-16-1439) dated 27 December 2017 and published in Umm Al-Qura Journal year (86) issue number (4249) dated 17 April 2009.