UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
the treatment of rare diseases, provided these prod- ucts have received provisional approval from certain reference health authorities. The EDE is preparing to update its list of authorised reference jurisdictions. Historically, however, it has accepted authorisations from the following regula- tory authorities. • The European Medicines Agency. • The US Food and Drug Administration. • The UK Medicines and Healthcare products Regu- latory Agency. • The Australian Therapeutic Goods Administration. • The Swiss Agency for Therapeutic Products. • Health Canada. • The Japanese Ministry of Health – Pharmaceuticals and Medical Devices Agency. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Manufacturing plants – referred to in the Law as Pharmaceutical Manufacturing Facilities – must be licensed by the EDE. To obtain a licence from the EDE for a Pharmaceutical Manufacturing Facility, the applicant must: • be the owner of the Pharmaceutical Manufacturing Facility; • obtain a valid Good Manufacturing Practice (GMP) certificate from the EDE; and • comply with the technical, health, and other requirements specified in the Implementing Regu- lation of the Pharma Law. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Pharmaceutical establishments engaged in the whole- sale of pharmaceuticals and medical devices must
obtain a licence from the EDE. An establishment con- ducting wholesale activities will primarily require a Medical Warehouse Licence. The application for a Medical Warehouse Licence – to store and possess medical products – is submitted through the EDE online portal. To obtain a Medical Warehouse Licence, the estab- lishment must meet the following requirements. • Obtain a valid Good Storage and Distribution Prac- tice (GSDP) Certificate from the EDE. • Appoint a licensed pharmacist for the technical management of the medical warehouse. If the medical warehouse’s activities are limited only to medical devices, then the medical warehouse may appoint a medical devices engineer or specialist instead of a pharmacist. • Secure approval from the UAE Ministry of Economy and Tourism regarding foreign ownership share percentages if the medical warehouse is located outside a free zone. In addition to the Medical Warehouse Licence, the pharmaceutical establishment must also obtain an EDE licence for any of the following activities:
• import; • export; • re-export; and/or • distribution.
The Executive Regulations of the Pharma Law will also specify any additional activities requiring a licence. These Regulations have not yet been released. A Biobank, Pharmaceutical Laboratory, Non-Clinical or Clinical Research Entity, Bioequivalence Center, Medical Products Factory, or a contracted Medical Products Manufacturing Company may also obtain activity permits from the EDE. 6.2 Different Classifications Applicable to Pharmaceuticals Pharmaceuticals may be classified as follows.
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