27/04/2021
The key facts about regulatory reforms in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? On 19 December 2019, the UAE government adopted a new federal law which was to overhaul Law No. 4 of 1983 on the Pharmacy Professional and Pharmaceutical Establishments…
The key facts about patents & trademarks in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? In the United Arab Emirates, patents are granted if the applications meet the criteria of Novelty, Inventive Concept (also known as Non-obviousness) and Industrial applicability. 2. What…
The key facts about product liability in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? In the UAE, Federal Law No. 24 of 2006 on Consumer Protection (Consumer Protection Law), as amended by Federal Law No. 7 of 2011, is the main piece of legislation relating…
The ins and outs of traditional medicines and OTC products in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? As per Article 1 of the Pharmacy Law of 1983, medicines are defined as “any medicine that contains one or more element…
26/04/2021
The key facts about marketing, manufacturing, packaging & labeling, advertising in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under the Pharmaceutical Law, all applications for marketing authorization must be made through the Ministry of Health (MOH). The authorization…
All legal aspects surrounding preclinical and clinical trial requirements in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is not an established requirement to conduct the clinical trials for products locally. As previously established, clinical trials are only required when the…
An insight into regulatory, pricing and reimbursement overview in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The UAE Ministry of Health (MOH) is the primary authority responsible for oversight of all the regulatory functions concerning pharmaceuticals in the UAE. The Ministry…
An insight into regulatory, pricing and reimbursement overview in the…
All legal aspects surrounding preclinical and clinical trial requirements in…
The key facts about patents & trademarks in the UAE.…
The key facts about regulatory reforms in the UAE. Prepared…
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