- 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 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.
- Federal Law No. 15/1980 concerned with Publications and Public Matters (“Publications Law").
The Publications Law states that advertisements on medicines or on pharmaceutical products may only be published after having obtained a special license from MOHAP and also imposes various additional specific obligations/conditions on advertisement of medical products.
- UAE Cabinet Resolution No. 7/2007 on prohibiting the advertisements or promotions of Medical Products without a valid license reaffirms the Ministerial Resolution No.430 of 2007 Regulating Health Advertisement by stating that anyone that does not have MOHAP approval and an issued licence is forbidden from advertising and promoting medical products.
- 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) 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 NMC to advertise and promote content electronically, in accordance with the general requirements of the EMR.
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