UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
• A substantial change in the composition, formu- lation, dosage form, or strength of the medical product. • A change in the product’s classification or route of administration. • Substantial changes in the manufacturing or production process that may affect the product’s quality, safety, or efficacy. • Substantial changes in the design of a medical device. • Voluntary withdrawal of the medical product from the market with the intention of reintroducing it with significant changes. • Pharmacovigilance findings requiring withdrawal, re-evaluation, or substantial modifications to the product. The following constitute minor changes to the medical product. In such cases, the existing MA remains valid and a new application is not required. Instead, the MAH must submit an application to amend the MA. • Minor changes in the product’s composition. • Introduction of new uses for the product. • Changes in the appearance or leaflet of the prod- uct. • Changes in the manufacturing location or the MAH’s address. • Minor changes in the manufacturing method. The MA may be transferred from one MAH to another with the approval of the EDE. The process, terms, and conditions governing such transfers will be set out in the forthcoming Implementing Regulations of the Pharma Law. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The Pharma Law introduces several exemptions to the requirement for a Marketing Authorisation. Physicians may prescribe medical products without an MA under a compassionate use exception. The specific details, terms, and conditions governing compassionate use programmes will be set out in the forthcoming Implementing Regulations of the Pharma Law.
Medical products may also be issued an Emergency Use Authorisation. To obtain such authorisation, there must be evidence of the product’s efficacy and ben- efits, supported by data from clinical research or trials. Additionally, there must be no adequate alternative treatment available, and a monitoring plan must be in place once the product is prescribed. The following products may be granted a condition- al MA, which is subject to less onerous application requirements and is valid for only one year. • Orphan pharmaceutical or biological products for the treatment of rare diseases (provided the prod- uct has already been granted temporary approval in a reference jurisdiction). • Medical products intended for the treatment of life‑threatening or serious diseases. • Medical products not currently available in the state for which no alternative exists. 3.6 Ongoing Obligations Imposed by Marketing Authorisations The MAH must implement a comprehensive quality assurance system, a product traceability system, as well as a pharmacovigilance and post‑marketing sur- veillance system. The MAH must appoint one or more qualified persons based in the UAE. A qualified person is an individual who holds a valid licence to practice pharmacy or medicine within the UAE. The MAH must appoint a minimum of two pharmaceu- tical establishments to act as importers of the medi- cal product, as well as at least one pharmaceutical establishment to distribute the product. If the medi- cal product is manufactured within the UAE, the MAH must additionally appoint at least one pharmaceutical establishment to store the product. The MAH must monitor the movement of the medical product throughout the distribution channels. The MAH must provide the necessary resources and systems required to meet all obligations associated with obtaining an MA.
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