UAE Implements New Pharmaceutical Regulatory Law
New UAE Law Regulates Pharmaceuticals: Fines Up to 1 Million AED
A new law has been introduced in the United Arab Emirates to regulate medicines, medical devices, health products, biological materials, dietary supplements, and cosmetics. The legislation aims to more effectively control the development and distribution of medical products and ensure safer and more transparent supervision of pharmaceutical businesses.
Scope of the Law
The new regulations announced on December 29, 2024, cover the following areas:
a, Medical Devices: These include diagnostic and therapeutic devices.
b, Pharmaceuticals: The manufacture and distribution of drugs intended for human and animal use.
c, Health Products: These include dietary supplements and cosmetics.
d, Biological Products and Biobanks: Regulation of institutions storing human samples.
The law also applies to pharmaceutical facilities operating in the UAE's free trade zones, making the new guidelines applicable to all stakeholders across the country.
Licensing and Oversight
The law provides a framework for licensing, supervising, and regulating pharmaceutical facilities and biobanks. It also governs the transfer of ownership rights and defines the roles of the Emirates Drug Establishment, the Ministry of Health, and local health authorities.
The regulations aim to enhance the transparency and safety of pharmaceutical processes and reduce the potential for abuse in the sector.
Penalties and Sanctions
Violating the new law incurs strict penalties, including:
a, Temporary suspension of the affected enterprise's license.
b, Precautionary closure, meaning the preventive shutdown of the facility.
c, Permanent withdrawal of licenses.
d, Fines that can reach up to 1 million AED for facilities or 500,000 AED for individual professionals.
Key Objectives
With the introduction of the law, the UAE aims to:
a, Ensure the regulated operation of the medical devices and pharmaceuticals market.
b, Create a safe environment for the development of health products.
c, Establish a supervisory system in line with international standards.
Impact on Industry and Consumers
The stricter regulations could contribute to improving the quality and safety of medical products. This also encourages consumers to trust products available in the UAE market more. However, businesses must pay increased attention to legal compliance to avoid severe penalties.
The UAE's new law could serve as an example for other countries where increasing transparency and safety in the health product market is a goal. This step further strengthens the country's position in health innovation and regulation.
