UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
The MAH must monitor the performance of the medi- cal product and receive reports from healthcare estab- lishments regarding its effectiveness, safety, and qual- ity. The MAH must comply with all guidelines and stand- ards issued by the EDE relating to pharmacovigilance. The MAH must follow up on all product recall proce- dures. The MAH must also follow up on matters concerning the protection of patents and manufacturing rights for the product. Under the UAE’s Guidelines in Good Vigilance Prac- tice (GVP Guidelines), no distinction is made between pharmaceuticals and medical devices; the guidelines apply similarly to both, where relevant. Under the GVP Guidelines, the MAH must. • Establish and maintain a system for the collec- tion and recording of all reports of suspected adverse reactions, whether reported spontane- ously by healthcare professionals or consumers, or observed in the context of a post‑authorisation study. • Put in place mechanisms that enable the traceabil- ity and follow‑up of adverse reaction reports while complying with applicable data protection legis- lation. Pharmacovigilance data and documents relating to individual authorised medicinal prod- ucts must be retained for as long as the product remains authorised, and for at least ten years after the MA has expired. The EDE may issue a Medical Devices Field Safety Alert for certain medical devices. When this occurs, the manufacturer must provide users with a Field Safety Notice containing details of the Field Safety Correction Action. Under Abu Dhabi’s Standard on Medical Device Reporting, the MAH must report any deaths, seri- ous injuries, malfunctions, and any public health risks requiring corrective action related to the medi- cal device. The MAH must also report any non‑urgent
safety matters, such as use errors, quality issues, or therapeutic failures. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Pending applications are not made public. MOHAP maintains a Registered Medical Products Directory, which contains information on approved medical products (not all fields apply to every prod- uct). The directory includes: • trade name, classification, price, pack size, form,
and strength (if applicable); • supplier name and address; • ingredients (if applicable); • relevant body system; • manufacturer and country of origin;
• dispensing mode; and • first registration date.
Information relating to the approved MA for the rel- evant product is governed by the PDPL and the UAE Health Information Law, as applicable. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes There is a Fast-Track Marketing Authorisation route for medical products that are innovative and of thera- peutic significance. The terms, controls, and requirement for the Fast- Track Marketing Authorisation are to be expanded upon in the forthcoming Executive Regulations of the Pharma Law. 4.2 Regulatory Reliance The UAE has adopted the concept of regulatory reli- ance and takes into account marketing approvals granted in reference jurisdictions when evaluating a product’s effectiveness, safety, and conformity with approved quality specification requirements. The EDE may issue a conditional marketing approval for orphan medical or biological products intended for
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