UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
The Health Information Law stipulates that health data may not be used for purposes unrelated to healthcare without the patient’s consent. However, scientific and clinical research is exempt from this consent require- ment, provided that the patient’s identity is not dis- closed. In addition, the Guidelines for Conducting Clinical Tri- als with Investigational Products and Medical Devices require that all information related to clinical testing must be recorded, monitored, processed, and stored in accordance with the PDPL and the Health Informa- tion Law. Pharmaceutical products are products that contain one or more active substances that achieve their intended purpose in or on the human or animal body through a biological effect. They are manufactured, sold, or offered for use in the diagnosis, treatment, cure, alleviation, or prevention of disease, as well as the restoration, renewal, modification, or correction of organ functions. Pharmaceutical products also include biological prod- ucts, food supplements, and cosmetic products. • Biological products are products obtained through biotechnology from a living organism. These include vaccines, monoclonal antibodies, growth factors, blood derivatives, plasma derivatives, advanced therapy medicinal products, and allergy diagnostic products. 3. Marketing Authorisations 3.1 Product Classification • Food supplements are products taken orally to support the human diet. They have no role in the treatment, diagnosis, or prevention of diseases and consist of natural products, partially manufactured products, or both. • Cosmetic products are products with a physi- ological effect that are used on the human body to produce a desired local effect on the skin, hair, or nails. They do not require a medical prescription or direct medical supervision when used.
Medical devices are products – whether a substance, device, instrument, appliance, implant, detector, or system, including accessories and operating soft- ware – that achieve their intended purpose in or on the human or animal body without a pharmacological, immunological, or metabolic effect. They are manu- factured, sold, or offered for use in the diagnosis, treatment, cure, alleviation, monitoring, or prevention of a disease, injury, or disability; the detection of, com- pensation for, or modification of an anatomical condi- tion; and the regulation of conception. To obtain an official classification of a medical prod- uct, an application may be submitted to the EDE. The EDE will then issue a classification letter specifying the product’s regulatory category. 3.2 Marketing Authorisation for Biologic Medicinal Products There is a distinct Marketing Authorisation (MA) appli- cation process for biological products, which must be submitted through the EDE portal. Biological products are subject to additional requirements compared to other medical products. To obtain an MA for a biological product, applications must be submitted in accordance with the eCTD for- mat. This format requires extensive quality, clinical, and non‑clinical data, including chemistry, manu- facturing and controls (CMC) information, as well as non‑clinical pharmacology, toxicology, and immuno- genicity studies, among other elements. A Good Manufacturing Practice (GMP) Certificate issued by the EDE, or an equivalent certificate from a reference jurisdiction accredited by the EDE, is also required. Conditional Marketing Authorisation may be granted for biological products intended for the treatment of rare diseases, provided the product has received pro- visional approval from a recognised reference jurisdic- tion.
369 CHAMBERS.COM
Powered by FlippingBook