UAE introduces new law regulating pharmacies, fine up to Dh1 million
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The UAE has enacted a new law aimed at regulating medical products, pharmacies, and pharmaceutical businesses to ensure improved oversight, organisation and security in the sector. Announced on December 29, the law encompasses medical devices, pharmaceutical products, biological items, supplements, cosmetics, and biobanks, including those operating in free zones.
The legislation sets a framework for licensing, supervision, and ownership transfers of pharmaceutical establishments and biobanks. It also defines the responsibilities of key entities such as the Emirates Drug Establishment, the Ministry of Health, and local health authorities.
Violations under the new law carry significant penalties, including temporary suspension of licenses, precautionary closures, license cancellations and fines reaching up to Dh1 million for establishments and Dh500,000 for practitioners.
Key provisions include:
- Regulation of medical product development, manufacturing, registration, pricing, import, export and distribution, along with safe disposal.
- Introduction of marketing authorisations for medical products, including exclusive, conditional and emergency use authorisations.
- Creation of a fast-track process for granting marketing approval for innovative therapeutic products.
- Protection mechanisms for pharmaceutical industry innovations and regulatory protection periods.
- Establishment of the Pharmaceutical Policies Committee to propose policies on the pricing, circulation, and monitoring of medical products.
- Development of systems to foster investment and innovation in the pharmaceutical sector.
- Organisation of pharmacovigilance procedures to ensure the safe use of medical products and reduce side effects.
- Issuance of a national policy for maintaining a strategic inventory of medical products.
This new legal framework is expected to strengthen the UAE’s healthcare and pharmaceutical sectors, promoting safety, innovation, and sustainable growth.