- Federal Law No.8/2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions (“2019 Law”).
The 2019 Law supersedes Law No. 4 of 1983 concerning Pharmaceuticals Profession and Institutions and Law No. 20 of 1995 Concerning Medicines and Preparations derived from Natural Sources. The 2019 Law unites different provisions which regulate how “Medical Products” are controlled in the UAE.
“Medical Products” is defined to cover “Medicinal Products” (i.e. pharmaceuticals/prescription drugs), “Medical Devices”, and “Healthcare Products” (i.e. generally referring to regulated products, but which could be sold without prescription or over-the-counter (OTC)).
The 2019 Law provides a thorough framework that governs areas such as: (i) import, export, distribution, warehousing and manufacturing; (ii) pricing; (iii) registration; (iv) advertising and promotion; (v) pre and post clinical trials; and (vi) safety reporting and product recalls.
With regard to advertisement specifically, the 2019 Law sets out clear conditions around how various categories of Medical Products can be advertised in the UAE. Failure to adhere with the requirements will be considered a criminal offence resulting in fines or imprisonment. Please see response in Q12 below.
The 2019 Law is supplemented by the following older Cabinet Decisions and Ministerial Decisions around licensing, content and process for advertising Medical Products.
- UAE Cabinet Resolution No. 7/2007 (as amended) on the Health Advertisements Regulation
reaffirms the Ministerial Resolution No.430 of 2007 Regulating Health Advertisement by stating that anyone that does not have approval from MOHAP and an issued licence is forbidden from advertising and promoting medical products. It also sets out the applicable license fees for the different categories/channels of advertisements and various prohibitions and requirements relating to the content of health/medical advertisements. For example, the advertisement shall contain true and balanced statements and should not deceive the public opinion and must include genuine facts and contents. Advertising licenses/permits will not be granted unless the relevant advertisement complies with the requirements of the applicable regulations.
- Ministerial Resolution No. 430 of 2007 Regulating Health Advertisement.
Where the subject matter of advertising is specifically related to Medical Products and services, advertisers must comply with special requirements. For example, the advertisement shall contain true and balanced statements and should not deceive the public opinion and must include genuine facts and contents. It is prohibited to publish any advertisements which advertise medicine or pharmaceutical products without the approval of MOHAP. Such an approval shall only be granted if the relevant advertisement complies with the requirements of the applicable regulations.
- Ministerial Decision No. 1412 of 2017 on the Approval of the Code of practice of the Marketing and Trading of Medical Products (the “Code”).
The Code sets out details around the nature, form and content of advertisements of Medical Products, and how manufacturers and distributors/agents of Medical Products are permitted to engage with the healthcare professional/healthcare sector in promotion of their products.
- UAE Cabinet Decision No. (21) of 2018 on the marketing of relevant feeding products for infants and young children.
Under this resolution, the Cabinet contributes to protecting, encouraging and supporting breastfeeding through regulating the activities of marketing and advertising of foods and nutritional products, which relate to feeding infants and young children. The Cabinet under this resolution also aims at providing appropriate information about the drawbacks of nutritional products to protect young children’s health.
- Electronic Media Regulation 2018 (EMR).
Under the EMR the UAE National Media Council (NMC), now succeeded by the UAE Media Council, specifically requires that any advertising of medicine and drugs on the internet/social media requires prior approvals from the competent authorities – alongside a specific licence from the UAE Media Council to advertise and promote content electronically, in accordance with the general requirements of the EMR.
A new media law was recently issued to replace the previous publications law, updating the regulatory framework to cover various new media types:
- Federal Decree-Law No. 55 of 2023 on the Regulation of Media (“Media Law”) .
The Media Law states that media activities (which includes the production, publication, dissemination and broadcasting of advertisements) can only be carried out with a license issued by the UAE Media Council (“Media Council”) and, while it does not specifically refer to advertisements for medicines or pharmaceutical products (which its predecessor the Publications Law (Federal Law No. 15/1980) did), the Media Law does note that media licenses from the Media Council are not substitutes for the permits or licenses to be issued by the Competent Authority. The Federal Ministry of Health and Prevention (MOHAP) would be the Competent Authority in the case of medical/health advertising. Accordingly, the licensing requirements remain the same under the New Media Law.
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