UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
sciences value chain. She leads major cross‑border licensing and collaboration transactions, including high‑value alliances, option agreements, and asset acquisitions. Winsome also advises on ecosystem‑wide initiatives, including serving as a chief legal adviser to a global antiviral consortium, and long‑term strategic partnerships in genomics. She regularly counsels investors and biotechnology companies on IP licensing, manufacturing, and commercial agreements.
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1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Pharmaceuticals and medical devices in the UAE are governed by Federal Decree-Law No 38 of 2024 Gov- erning Medical Products, Pharmacists, and Pharma- ceutical Establishments (“Pharma Law”). The Phar- ma Law refers to both pharmaceuticals and medical devices as “medical products”. The Ministry of Health and Prevention (MOHAP) and the Emirates Drug Establishment (EDE) are the regu- latory bodies that apply and enforce pharmaceutical and medical device regulation at a federal level. MOHAP, as a UAE federal ministry, is part of a cen- tralised administration, whereas EDE is a semi-auton- omous regulator. There are emirate-level regulators that issue regula- tions for their respective emirate as well:
• the Dubai Health Authority (DHA) in Dubai; and • the Abu Dhabi Department of Health (DOH) in Abu Dhabi. 1.2 Challenging Decisions of Regulatory Bodies Under the Pharma Law, certain decisions may be appealed. These include the rejection of an appli- cation for a pharmacist licence and any disciplinary penalty issued under the Pharma Law. Appeals must be filed within 15 days. The Pharma Law does not specify the detailed requirements or procedures for filing such appeals, which are expected to be clari- fied in the forthcoming Implementing Regulations (IR). In addition, claimants may challenge certain decisions issued by MOHAP or the EDE. Specifically, MOHAP provides an appeal service for decisions issued by the Medical Licensing Committee and for previously recorded health advertisement violations.
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