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?

Federal Law No. 8/2019

Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions (the “2019 Law”) supersedes Law No. 4 of 1983 and Law No. 20 of 1995. It provides a comprehensive framework regulating medical products in the UAE, including pharmaceuticals, medical devices, and healthcare products.

The law governs import, export, distribution, warehousing, manufacturing, pricing, registration, advertising, promotion, clinical trials, safety reporting, and product recalls. It sets strict conditions for advertising medical products, with violations constituting criminal offenses punishable by fines or imprisonment.

Supplementary Regulations

UAE Cabinet Resolution No. 7/2007 and Ministerial Resolution No. 430 of 2007: Require MOHAP approval and licensing for medical advertisements and mandate that advertisements be truthful, balanced, and not misleading.
Ministerial Decision No. 1412 of 2017: Establishes the Code of Practice for Marketing and Trading Medical Products and governs promotion to healthcare professionals.
UAE Cabinet Decision No. 21/2018: Regulates the marketing and advertising of infant and young child feeding products.
Electronic Media Regulation 2018 (EMR): Requires prior approval and licensing for online advertisements of medicines and medical products.
Federal Decree-Law No. 55 of 2023 (Media Law): Updates the regulatory framework for media activities, including advertising, and requires licenses from the UAE Media Council.

2. Are there any additional legislative frameworks or self-regulatory codes of conduct?

The Ministry of Health and Prevention (MOHAP) is the primary regulator governing advertising of medical products. Certain Emirates have additional authorities such as the Dubai Health Authority (DHA), Health Authority Abu Dhabi (HAAD), and Sharjah Health Authority (SHA), which enforce local regulations.

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

Market Authorisation

Market Authorisation from MOHAP is mandatory before any medical product may be imported, distributed, or advertised. Authorisation is granted only after registration and classification of the product by MOHAP.

Advertising Approval Process

Advertising approval applications are submitted online through MOHAP, typically by a UAE-based marketing agent. Applications must include the Marketing Authorisation, advertisement samples, and details of media platform, location, and duration.

Additional Approvals and Fees

In some cases, additional approvals from DHA, HAAD, or SHA may be required. Advertisement fees vary by category and medium in accordance with Cabinet Resolution No. 7/2007.

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

Article 39 prohibits advertising prescription-only medicines, except in scientific publications intended for healthcare professionals and only with MOHAP approval.

Advertising of non-prescription medicines and non-prescription medical devices is permitted, provided the product has Marketing Authorisation and the advertisement is approved by MOHAP.

The Code

Marketing materials must target only relevant individuals.
Recipients have the right to opt out of communications.
Mass public distribution is prohibited.

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

General Requirements

Advertisements must be accurate, balanced, impartial, and non-misleading. They must allow recipients to form independent opinions and include information on contraindications, precautions, and side effects. Terms such as “safe” and “effective” must be used cautiously.

Prohibited Content

Violation of UAE laws or Islamic values
Misleading or deceptive information
Damage to public interest
Promotion of prohibited services, including abortions, embryo freezing, or treatment of certain diseases such as cancer, STDs, AIDS, hepatitis, or mental disorders

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

Electronic Marketing

Prior consent from healthcare professionals is required before marketing via email, SMS, or other electronic communications.

Hospitality and Gifts

Strict controls govern hospitality and gifts offered to healthcare professionals by medical product companies or during sponsored events.

Provision of Free Goods

Free goods to pharmacies are capped at 15% of invoice value
No cash or cash-equivalent inducements are permitted

Product Samples

Samples may be provided in reasonable quantities
Must be labeled “free medical sample – not for sale” in Arabic and English
Samples may not be sold or traded

Sponsorship and Educational Support

Additional restrictions apply to sponsorship of conferences, education programs, and similar activities.

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

Accurate, balanced, impartial, and comprehensive content
Basic safety information including contraindications and side effects
MOHAP approval of content, form, and placement
Claims based on recent and credible medical research
Restricted and accurate use of “safe” and “effective”

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

Requirements mirror those for healthcare professionals, with mandatory MOHAP approval prior to publication across all media.

9. Are there constraints on data supporting promotional claims?

All promotional data must be accurate, balanced, and approved by MOHAP. Advertising must not mislead through distortion, exaggeration, omission, or undue emphasis.

Conflicting scientific studies must be disclosed. Animal study data must not be cited if it may misrepresent relevance to humans.

10. Are there rules governing comparative advertising?

Comparative advertising must be based on relevant and comparable criteria, must not mislead or denigrate competing products, and must be scientifically valid.

False or misleading comparisons constitute unfair competition under Federal Commercial Transactions Law No. 18 of 1993 and Consumer Protection Law No. 15 of 2020.

11. Are there special guidelines for advertising on the internet and social media?

MOHAP and the Code

All online and social media advertising must be reviewed and approved by MOHAP before publication.

Electronic Media Regulation (EMR)

EMR requires prior approval and a UAE Media Council license for online advertising, including influencer marketing involving paid or non-monetary benefits.

Media Law

Advertisements on digital platforms must include clear disclosure that the content is advertising.

Dubai Health Authority SMA Guidelines

These guidelines require transparency in promotional relationships and prohibit promotion of non-therapeutic, unproven, or harmful products.

E-Commerce Commentary

Regulatory clarification is ongoing regarding whether displaying medical products on e-commerce platforms constitutes advertising, particularly in relation to e-pharmacies.

12. Which bodies oversee compliance and what are the legal ramifications?

MOHAP

MOHAP is the primary regulator overseeing advertising and promotion of medical products.

Enforcement and Penalties

Corrective actions and fines imposed by MOHAP
Criminal penalties under the 2019 Law, including imprisonment or fines
UAE Media Council fines between AED 100,000 and 200,000 for EMR violations
Media Law penalties ranging from warnings to AED 1,000,000 fines, license suspension, or closure

13. Are there any future developments in the UAE?

Further consolidation of medical advertising regulations
Clarification of rules governing e-pharmacies and e-commerce platforms
Expanded digital media regulations under the UAE Media Law

How can OMC help?

Professional review of marketing and advertising materials with reports
Services to obtain authority approvals where required
Translation of marketing materials by a professional translation agency certified with ISO 17100