The UAE’s new pharmaceutical law: 10 things businesses should know

The new Federal Decree-Law No. 38/2024 Regarding Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments replaces previous legislation in place since 2019 and supports the UAE’s goal of being an internationally trusted centre for pharmaceutical and medical industries.

The new law will impact a range of medical stakeholders, including clinical and non-clinical research entities, pharmaceutical laboratories, manufacturers, pharmacies, biobanks, warehousing and storage companies, and marketers.

Executive regulations, which will set out the various implementation procedures and processes relevant to the new law in more detail, are yet to be issued – the executive regulations of the previous law remain in effect to the extent they do not contradict the new law.

The new law regulates many aspects of the management of medical products, and spans over 50 pages, so we have picked out 10 points to be aware of now.

1. The Emirates Drug Establishment (EDE)

The new law introduces the EDE, which will be taking over from the Ministry of Health and Prevention as the main authority issuing medical product approvals, including marketing authorisations (MAs), import/export permits, licensing, and advertising approvals. It will also issue good practice certificates, monitor for pharmacovigilance, and suspend or withdraw medical products if necessary.

2. Scope of products

The new law expands the scope of definitions to include more detailed descriptions of terms such as ‘medical product’, ‘pharmaceutical product’, and ‘biopharmaceutical products’, providing clearer classification guidelines and expanding the scope of regulated products. The widened scope has expanded to specifically include biopharmaceuticals, food supplements, cosmetic products and genetically modified organisms intended for medical use, as well as the traditional medicines, medical devices and pharmaceuticals covered by the previous law.

3. Routes to marketing authorisation

The new law outlines a more stringent process for obtaining MAs for medical products, which includes more comprehensive requirements for clinical evaluations, safety and efficacy assessments and pharmacovigilance systems. Granted MAs are valid for five years and can renewed for similar periods.

The new law also sets out the following additional types of MA available to applicants:

• Exclusive MAs: granted to a single entity, allowing them to exclusively market specific medical products to specific entities within the UAE, without the need for an entity to obtain a separate MA.
• Conditional MAs: available for, for example, orphan drugs, treatment of rare diseases or other medical products unavailable in the UAE, if an MA has been issued in a recognised reference country. They are granted under specific conditions and are subject to a commitment to apply for a regular MA once the reasons for requiring conditional approval pass. They are valid for up to one year and may be renewed.
• Emergency use MAs: granted in situations where there is an urgent need for a medical product, such as during a public health emergency or pandemic. This type of authorisation allows for the rapid deployment of medical products that have not yet completed the full regulatory approval process, and lasts throughout the duration of the relevant public health emergency.
• Fast-track MAs: simplified procedures to be established to grant MAs for innovative medical products of therapeutic importance. The exact pathway is to be specified in the executive regulations to the new law, which are yet to be released.

4. Protections for innovative medicines

The new law introduces specific regulatory protections for documents and data relating to innovative medical products and medical products containing at least one new active ingredient, reflecting a strong incentive for innovative products to be launched in the UAE. The exact period, mechanism and system for this protection is to be specified in the upcoming executive regulations to the new law. It remains to be seen how this will interact with existing market and data protection regulations in other jurisdictions, as well as existing intellectual property laws.

5. Scope of establishments

A broader range of establishments and companies are in-scope of the new law compared to the previous law. The new law covers pharmaceutical establishments including research and development entities, laboratories, manufacturers, pharmacies, marketing offices, warehouses and storage facilities. It also specifically covers biobanks, which were not explicitly covered by the old law.

6. Pharmacovigilance and safety

The new law sets out enhanced pharmacovigilance standards, with stricter monitoring, adverse event reporting requirements and mandatory reporting timelines, replacing the more basic requirements of the old law. The precise controls, conditions and good practices of pharmacovigilance are to be further outlined in a decision of the EDE board.

7. Quality and manufacturing

The EDE will publish and update an “approved pharmacopoeia” for the UAE, which will define essential requirements for the quality of pharmaceutical and medical products, and provide manufacturing guidelines to ensure that medicinal products produced in the UAE comply with strict safety, efficacy and quality standards. The ESE will also create a national system to track and code medical products from the manufacturer to the end user, which will help to ensure safety and authenticity of medical products circulating in the UAE.

8. Advertising

The new law mirrors the previous position that medical products may not be advertised by any means unless approval is obtained from the relevant authority – previously the Ministry of Health and Prevention; now the EDE. However, the new law sets out the position in more detail and lists the specific conditions under which the EDE will issue advertising approvals.

9. Import and export regulations

The new law introduces new provisions for the import and export of medical products, including the need to obtain a permit, stricter documentation requirements and enhanced oversight by the EDE. This aims to prevent the circulation of counterfeit or substandard products.

10. Penalties and enforcement

The new law imposes harsher penalties for violations, including higher fines of up to 1 million AED ($270,000) and longer imprisonment terms. It grants the EDE greater enforcement powers to conduct inspections, seize non-compliant products, cancel or temporarily suspend licenses, and shut down establishments that violate regulations.

What next?

Establishments and individuals covered by the new law have been granted a one-year grace period to comply with its provisions, unless an extension is granted by the Council of Ministers.

We can expect the new executive regulations and any EDE decisions to shed more light on additional conditions for key concepts such as MA approvals, fast-track MA applications, regulatory protection for innovative products and precise pharmacovigilance standards. Medical stakeholders should keep an eye out for these and, in the meantime, familiarise themselves with the new regulations and seek advice in relation to their compliance.