UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
• Over‑the‑counter medicines – non‑prescription pharmaceutical products available for purchase without the need for a prescription. • Pharmacist‑only medicines – pharmaceutical products that must be dispensed by a pharmacist, though a prescription is not required. • Prescription‑only medicines – pharmaceutical products that must be dispensed by a pharma- cist and require a valid prescription issued by a licensed practitioner. • Semi‑controlled drugs – non‑narcotic pharmaceuti- cal products that may provide medical benefits but carry risks of habituation or addiction, particularly with long‑term use, high doses, or when combined with other substances. • Controlled drugs – pharmaceutical products that require special control procedures. This includes toxic substances, certain plants, prohibited veteri- nary substances, narcotic and psychotropic sub- stances, and other hazardous medical products. • Narcotics – products as defined and listed under Federal Decree‑Law No 30 of 2021 on Combating Narcotics and Psychotropic Substances. • Non‑registered drugs – when no registered phar- maceutical product is available, a health facility may apply to the Ministry of Health and Prevention for authorisation to procure a non‑registered phar- maceutical product. The UAE is a signatory to the United Nations Office on Drugs and Crime’s International Drug Control Conven- tions. These international commitments are reflected in national legislation governing drug classification and the control of narcotic and psychotropic sub- stances. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The Pharma Law governs the importation and expor- tation of pharmaceuticals and medical devices. The EDE is responsible for issuing the permits and licences required for such import and export activities.
The UAE Federal Customs Authority enforces the import regulations at the point of entry, after which enforcement is carried out by the EDE. The DHA and the DOH may also participate in enforcing the import regulations within their respective Emirates, working in co-ordination with the EDE. 7.2 Importer of Record of Pharmaceuticals and Medical Devices The Pharma Law defines an “importer” as a legal enti- ty licensed by the EDE to import medical products into the UAE. To obtain an EDE import licence, the legal entity must meet the following requirements. • Obtain the product’s Marketing Authorisation from the EDE. • Ensure that the local agent listed in the product’s MA is the party responsible for carrying out the importation. • Secure electronic approval for the shipment from the UAE Federal Customs Authority. • Include a commercial invoice for the product with each initial import permit request. • Undergo an inspection at the customs port con- ducted by EDE inspectors. • Complete an inspection for the purpose of releas- ing the shipment for distribution in the local market. Additionally, the holder of the MA must appoint at least two pharmaceutical establishments to import the medical products into the UAE, and must appoint at least one pharmaceutical establishment to distribute the products. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices See 7.1 Governing Law and Relevant Enforcement Bodies and 7.2 Importer of Record of Pharmaceuti- cals and Medical Devices . There are no exemptions from the importation authori- sations, including for over‑the‑counter pharmaceuti- cals and medical devices. To import a pharmaceutical product or medical device for personal use, an individual must apply for a sepa-
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