Pharmaceutical advertising regulation and medical device advertising in the United Arab Emirates

• 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. 

The relevant laws are described above.

MoHAP governs and regulates the importation, manufacturing, use and advertising and sale of Medical Products (defined above) in the UAE and is the only authority that issues licenses for these activities, including specific licences for each medical advertisement.

Some Emirates have authorities that regulate the policies and overall healthcare quality, e.g. the Dubai Health Authority for the Emirate of Dubai (“DHA”), the Health Authority for Abu Dhabi for the Emirate of Abu Dhabi (“HAAD”) and the Sharjah Health Authority for the Emirate of Sharjah (“SHA”). These Emirate-level regulators will implement specific additional regulations that apply to Medical Products and the overall provision of healthcare within that Emirate, all ultimately falling within the scope of the Federal Laws described a Question 1 above.

Medical Products must have a specific “Market Authorisation” issued by MOHAP prior to any Medical Product being authorised for importation and circulation in the UAE. Similarly, no Medical Product may be advertised, marketed or promoted in the UAE unless and until a Market Authorisation for the product is issued by MOHAP. Such authorisation is only granted if the relevant Medical Product has been duly registered with and classified by MOHAP and once registered and authorised, the relevant Medical Product must only be promoted for the purposes that it was duly authorised for, as set out on its approved Market Authorisation Certificate, which will also set out details of instructions/information and other matters that must appear on product labelling. (Note, this does not restrict scientific and “non-marketing” exchange of information in scientific journals/magazines/conferences aimed at healthcare professionals.)

The application for advertising/marketing approval can be made online. Typically this is done by a marketing agent based in the UAE as appointed by the manufacturer, who would then be engaged to import and distribute the products in the UAE. Once Marketing Authorisation has been granted by MOHAP, it is then a requirement that all intended advertising/marketing tools are reviewed by MOHAP prior to implementation. The proposed advertising/marketing tools can be uploaded on the MOHAP website electronically, once an account has been registered with MOHAP. Registering the account requires uploading several documents, including the relevant Marketing Authorisation, example product advertisement, and the desired location/type of advertisement, media platform and duration for the approval of that specific advertisement (e.g. 1 month, 3 months, 6 months etc).

In addition to the above, the DHA, the HAAD or the SHA may need to review the contents of the advertising/marketing of medical products/pharmaceuticals prior to them being implemented in that Emirate on a case-by-case basis.

The Code does not include any specific professional qualifications/licences required from medical sales representatives when carrying out any advertising activities in the UAE. However, medical sales representatives are expected to demonstrate a good understanding and be adequately trained to present sufficient scientific knowledge when promoting Medical Products. 

The Code applies to the advertising/marketing of Medical Products to the general public and healthcare professionals alike. 

Yes.  

2019 Law. Article 39 of the 2019 Law prohibits the advertisement of any prescription only drugs. The only exception is the promotion of those prescription only drugs in scientific resources or magazines intended for healthcare practitioners, and then only with the approval of MOHAP. However, the general promotion of non-prescription drugs/products, including non-prescription medical devices, is permitted provided the product has a Marketing Authorisation and the advertisement is approved by MOHAP. 

The Code. The Code requires that all advertising/marketing materials, regardless of whether the item is over the counter or a prescription medication, must only be targeted at relevant individuals who require this specific information or would be interested in it. These individuals, in turn, have a right to opt out of receiving such material. Mass distribution of advertising/marketing materials to the public is specifically prohibited. 

Please see Question 4 above. In brief, MOHAP approval is required for any advertisement of a Medical Product, including any medicine or medical device. 

The Code sets out detailed standards (requirements, prohibitions so on) regarding advertising/marketing materials. A key principle under the Code is that marketing materials must be both accurate and comprehensive enough to enable a recipient to form their own opinion as regards the therapeutic value of the Medical Product. The marketing materials must be accurate, balanced, impartial, objective and complete, based on a recent assessment of the medical research/evidence. It must not be misleading through distorted information, exaggeration, unjustified focus, omission or in other ways. The words “safe” or “effective” shall not be used without restriction and particular attention shall be given to basic information on the safety of the product, such as contraindications, precautions and side effects.

The relevant Medical Product must only be advertised/marketed for the purpose that it was duly authorised for by the MoHAP, as set out on its approved labelling. 

The Media Law and the NMC Advertising Code (now administered by the UAE Media Council) also imposes the following general restrictions on advertising which are also applicable to medicines and medical devices:

• Advertisements must be in line with the law and must not breach any rules in the UAE;
• UAE traditions, Islamic beliefs and customs must be closely considered and advertisements must not undermine these values;
• Advertisements must be real, clear and concise, must not be exaggerated and must not misdirect individuals;
• Advertisements must not damage the public interest;
• Advertisements must clearly disclose their status as advertising material       

Certain advertising of medicines and medical products is explicitly prohibited due to its content. It is a violation of the law to advertise the following products and services: 

• Abortions;
• Embryo freezing;
• Products that are proven to be harmful to individuals;
• Treatment or preventing the following diseases: cancer, STDs (sexually transmitted diseases), AIDS (Acquired Immune Deficiency Syndrome), hepatitis, mental and psychological disorders.

Please see Questions 4 and 5 above for regular advertisements and specific prohibitions/carve outs regarding healthcare professionals.

In addition, the Code sets out detailed provisions regarding how manufacturers/promoters of Medical Products shall promote those products to and engage with healthcare professionals. For example:

• marketing via e-mail, SMS or other electronic means of communication requires prior approval of the healthcare professional;
• strict and detailed controls are imposed around hospitality and gifts offered to healthcare professionals by medical product companies (or at event sponsored by them);
• the free goods which a manufacturer/sales agent can provide to a pharmacy are capped at 15% of the value of underlying invoices for products purchased by the pharmacy. No cash or equivalent benefits are permitted to induce regular business from pharmacies/healthcare institutions;
• samples of a product may be offered to healthcare professionals allowing them to prescribe those products, provided the samples are in reasonable quantities, stating clearly they are samples, and such samples shall not be sold/traded. Samples must have the phrase “free medical sample – not for sale” written on it in Arabic and English language. 

Additional restrictions/conditions are imposed on things like sponsorship of medical conferences, education support and so on. 

The Code sets out detailed standards (requirements, prohibitions so on) regarding advertising/marketing materials, which (in relation to information in advertisements for specific products) does not distinguish between healthcare professionals and the general public. A key principle under the Code is that marketing materials must be both accurate and comprehensive enough to enable a recipient to form their own opinion as regards the therapeutic value of the Medical Product. The marketing materials must be accurate, balanced, impartial, objective and complete, based on a recent assessment of the medical research/evidence. It must not be misleading through distorted information, exaggeration, unjustified focus, omission or in other ways. The words “safe” or “effective” shall not be used without restriction and particular attention shall be given to basic information on the safety of the product, such as contraindications, precautions and side effects. 

The content, form, location and other aspects of all advertisements of authorised Medical Products must be approved by MOHAP before they can be published in any media, whether to healthcare professionals or to the general public. In assessing each advertisement application, MOHAP will also consider the provisions set out in the Marketing Authorisation Certificate for the relevant product, and the Code. 

Please see Question 7 above. 

As noted above, under the Code, all marketing materials must be accurate, balanced, impartial, objective and complete, based on a recent assessment of the medical research/evidence. It must not be misleading through distorted information, exaggeration, unjustified focus, omission or in other ways. The words “safe” or “effective” shall not be used without restriction and particular attention shall be given to basic information on the safety of the product, such as contraindications, precautions and side effects. 

In that context, the Code requires that scientific data used in advertising/marketing must be approved by MOHAP and that it be balanced and accurate. For example, scientific data from the findings of a study may only be quoted if data from another valid, clinically relevant scientific study which contradicts or questions the data of such findings is also published. Study data shall also not be cited or published which might give the recipient a false or misleading impression about the nature, scope, outcome, application or importance of the study, and data from animal testing shall not be cited if it might give a distorted impression of the application to humans. 

The Code requires that statements of comparison between different Medical Products must be based on relevant and comparable aspects of the product. The comparative advertisements must not be misleading or degrade the other product and must be valid and made in a scientifically appropriate and balanced manner. 

More general rules regarding comparative advertising are also set out under the following laws:

• Federal Commercial Transactions Law No. (18) of 1993.The Commercial Transactions Law provides that an advertisement containing false information either about the advertised product or about a product possibly being compared therewith will amount to a form of unfair competition and in terms of this legislation, such advertisements will expose the advertiser to claims for damages.
• Federal Law No. 15/2020 on Consumer Protection and its implementing regulations Cabinet Decision No.66/2023 (Consumer Protection Law). The Consumer Protection Law provides that a supplier may not 

Advertisers, suppliers and commercial agents must not describe goods in a manner that contains incorrect data or make any misleading advertisement. An advertisement will be deemed deceptive if it contains a misleading claim which may directly or indirectly create a false or misleading impression to the consumer, including in respect of the character and expected results of the product.

The Code requires that all intended advertising/marketing tools are reviewed by MOHAP prior to implementation. The proposed advertising/marketing tools for use on social media/internet can be uploaded on the MOHAP website electronically, once an account has been registered with MOHAP. Registering the account requires uploading several documents, including the relevant Marketing Authorisation Certificate for the product.

Electronic Media Regulation 2018 (EMR) 

The EMR 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. 

The scope of EMR is broad in nature and covers the presentation or promotion of ideas, goods or services by electronic means or applications, whether paid or unpaid, and it is element of the EMR that catches influencers who use their social media accounts to commercially advertise Medical Products. ‘Commercially’ in this context, however, is not limited to paid-for activity. Influencers and bloggers who receive non- monetary benefits (e.g. free products or free entry) to promote a particular brand or event will therefore require a licence from the UAE Media Council. 

The Media Law 

Advertisements  or promotions, whether on a paid or unpaid basis, on social media platforms and other modern technical means fall within the scope of electronic and digital media activities that require licenses and permits from the UAE Media Council and/or any other competent authority. All advertisements must include clear disclosures that it is advertising content. 

NMC Advertising Guidelines 

Guidelines previously issued by the NMC (now administered by the UAE Media Council) provide that social media advertisements must comply with all applicable advertising standards and content requirements and account holders are responsible for the content of their accounts. The guidelines include detailed guidance on required disclosures and placement of advertisements alongside other content. 

Dubai Health Authority Guidelines for Medical Advertisement Content on Social Media (“SMA Guidelines”). 

The SMA Guidelines apply only in the Emirate of Dubai, and reinforce the need for healthcare advertising on social media (which is very broadly defined to cover a range of platforms) to be accurate and safe. The SMA Guidelines also state that health facilities and healthcare professionals receiving financial or other material benefits for promoting healthcare, or non-healthcare, related products or services should have a transparent relationship with the relevant organisation (or individual) and this should be documented and disclosed to their patients. They should also avoid the promotion of: 

• Non-therapeutic products;
• Products and services not directly related to healthcare;
• Products and services that are not proven to be healthy or sound;        
• Products that are not supported by clinical evidence;
• Products that affect health adversely.

Commentary: A current nuance of local law that is being debated with the relevant authorities is whether e-commerce platforms constitute “social media platforms” for these purposes, and whether making Medical Products available on their websites constitutes an “advertisement”. This is an area of new development, accelerated since the impact of COVID with the introduction of an “E-Pharmacy Licence” for businesses to distribute Medical Products (available for pharmacy distribution or OTC) to customers via their e-platform. If e-commerce platforms are deemed to be “advertising” medical products by having them available for inspection on their virtual shelves, whereas regular supermarkets which might sell OTC products are not deemed to be “advertising” those products by having them available for inspection on their regular shelves, this could create an imbalance between online and in-store sales of OTC Medical Products and those sold via E-Pharmacies. 

MOHAP is the primary regulator for all matters relating to advertisement / promotion of Medical Products in the UAE. 

Under the Code, the Pharmaceutical Licensing Committee of MOHAP can investigate any violations and take any necessary corrective measures against liable parties. At a minimum, fines can be imposed and the offending or non-complying materials will be removed. under the 2019 Law, individuals or companies that fail to adhere to the requirements under the 2019 Law will be considered to have committed a criminal offence. Non-compliance with the provisions of the 2019 Law is punishable by imprisonment or (more commonly) a fine which would be levied by MOHAP. The duration of imprisonment and the size of fines levied will depend on the nature and scale of the violations. The penalties prescribed under this Pharmacy Law will not prejudice any more severe penalty provided for in any other law. 

EMR. The UAE Media Council (previously the NMC) can impose fines of AED 100,000 to 200,000 for publishing advertisements online and on social media without the relevant authorisations from both MoHAP and the NMC. 

The Media Law. Administrative penalties under the Media Law include warnings and fines of between AED1,000- AED1,000,000 (which may be doubled in the case of repeated offences). For serious offences, offending facilities and media institutions may be closed for 6 months and/or have their license, permits and approvals revoked. Further details on penalties and enforcement are expected to be provided in the implementing regulations to the Media Law once issued. 

The 2019 Law has consolidated various previous laws which governed this area of law in the UAE. However, some historical regulations still exist outside of the 2019 Law, as described above. We expect further consolidation of those ancillary laws/regulations and improvement of the legal regime in the coming years. 

In particular, the regulations around e-pharmacies and the promotion / sale of regulated Medical Products on e-commerce platforms is an area which needs to be addressed clearly and is currently causing some debate between the authorities and industry stakeholders.

The media regulatory landscape in the UAE generally is also currently under review and the subject of modernizing regulations. The implementing regulations[GR1]  to the recently issued UAE Medial Law are yet to be issued and we expect these to cover advertising in more detail, including across digital media and platforms.