Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

1.1 Medicines

Implementing Regulations of Pharmaceutical and Herbal Establishments and Products Law (2020)
Guide for the Rules and Procedures for Marketing Advertising Pharmaceutical and Herbal Products (2022)

1.2 Medical Devices

Medical Devices and Products Law
Implementing Regulations of the Medical Devices and Products Law
MDS-REQ8 Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical Devices (2022)

2. Are there any additional legislative frameworks, such as self-regulatory codes of conduct, that control the advertising of pharmaceuticals and medical devices?

Saudi Code of Pharmaceutical Promotional Practices: An ethical code for the promotion of pharmaceutical products, applicable to pharmaceutical companies, manufacturers, and healthcare professionals. This code mandates accurate, up-to-date, and non-biased promotional information and prohibits promotion before obtaining a marketing authorization license from the SFDA.

3. What licenses, approvals, or fees are required for advertising medications and medical devices?

3.1 Medicines

SFDA Approval: Required for advertising pharmaceutical products to the general public. A non-refundable fee of SAR 14,000 applies for each advertisement.
Social Media Influencers: Specific SFDA approval is required for advertisements through influencers, with a fee of SAR 14,000 per advertisement.
Healthcare Professionals: No SFDA approval or fees are required for advertising to healthcare professionals, provided the advertisements comply with the Guide.

3.2 Medical Devices

Medical Devices Marketing Approval (MDMA): Required for the sale, lending, or donation of medical devices. Marketing materials must be submitted as part of the MDMA application.
Approval of Medical Device Advertisement (AMDA): Required for advertising medical devices. Fees are SAR 3,000 for general public advertisements and SAR 6,000 for advertisements to healthcare professionals.

4. Does Saudi Arabia law govern the advertisement of prescription and over-the-counter medications differently?

Prescription-Only Medicines (POMs): Advertising to the general public is prohibited, except in scientific publications, conferences, and workshops directed at medical practitioners. POMs may be advertised to healthcare professionals.
Over-the-Counter (OTC) Medicines: Advertising to the general public is allowed but must receive SFDA approval and comply with the Guide.

5. What are the primary limits on promoting drugs and medical devices to the public?

5.1 Medicines

Advertisements may only be for non-prescription products
Products must be listed with the SFDA
Advertisements must not contain uncertified claims or misleading information
Advertisements must not demean other products
Social values and public decency standards must be respected

5.2 Medical Devices

Advertisements must not mislead regarding device performance
SFDA approval must be included
Professional-use device advertisements must be in English
General public advertisements must be in Arabic
Content and presentation must avoid misleading consumers

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

6.1 Medicines

Advertisement records must be retained for three years
Advertisements must be in English
Balanced information on effectiveness, safety, and side effects is required
Advertising is limited to scientific journals and conferences

6.2 Medical Devices

Advertisements must meet the professional needs of healthcare professionals
Sales representatives must have adequate product knowledge
Advertisement content must be SFDA-approved
Professional advertisements must be in English

7. What information is required for advertisements directed only at healthcare professionals?

7.1 Medicines

Trade name of the product
Scientific name of the product
Name and address of the marketing company or agent
Scientific references supporting the information
Dosage, side effects, precautions, and method of use

7.2 Medical Devices

Relevant information tailored to professional needs
Name of the device
Name and address of the manufacturer
Document control reference number (MDMA requirement)
Medical device advertising license number (if separately approved)
Excludes the SFDA logo and establishment National Registry Number, but may include the Medical Device National Listing Number
Avoidance of misleading phrases
Compliance with Saudi law on Printed Materials and Publication

8. What information must be included in public-facing advertisements?

8.1 Medicines

SFDA approval number
Trade name and active ingredients
Disclaimer regarding side effects and consultation with a doctor or pharmacist

8.2 Medical Devices

Information similar to professional requirements
Content must be understandable to the general public
Advertisements must be presented in Arabic

9. Constraints on data supporting promotional claims

For medicines, advertising content must align with the patient information leaflet and the summary of product characteristics. All claims must be supported by reliable scientific references.

For medical devices, the SFDA requires scientific supporting documents, including clinical study data or other reliable sources, to substantiate advertised claims.

10. Rules governing comparative advertising

Comparisons must be based on relevant and statistical points
Comparisons must not be misleading or demeaning
Guidelines discourage comparisons that harm other products’ reputations

11. Guidelines for internet and social media advertising

Medicines

Online advertisements must remain on the applicant’s website
Redirection to other sites is prohibited
Social media advertisements require SFDA pre-approval
Advertisements must be posted by licensed influencers

Medical Devices

Internet advertisements must not mislead the general public
SFDA online advertising guidelines must be followed

12. Oversight bodies and legal consequences

Medicines

SFDA enforces compliance with advertising regulations
Fines up to SAR 5,000,000
Temporary closure of establishments for up to 180 days
Complete revocation of establishment licenses

Medical Devices

SFDA enforcement under Article 42 of Medical Devices Regulations
Fines up to SAR 5,000,000
Temporary suspension for up to 180 days
Product recall or market withdrawal
Revocation of MDMA or establishment license

13. Future developments in Saudi Arabia

The SFDA continually updates regulations. At present, no significant future developments are expected to alter the existing advertising framework for medicines and medical devices.

How can OMC help?

Professional review of marketing and advertising materials with detailed reports
Support in obtaining authority approvals where required
Translation of marketing materials by an ISO 17100 certified professional translation agency