6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

Article 51 of the Ministry of Health and Prevention’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” sets forth the requirements to obtain an export license for biological samples:

“Article 51. 

Paragraph 51.1 Only the sponsor or an authorized representative can export from the territory of the UAE to third countries all types of biological samples from clinical trials. 

Paragraph 51.2 In order to obtain export authorization (license), the person under Paragraph 51.1 shall file with the Drug Control Department at the MOHP: 

• 51.2.1 an application based on a model approved by the MOHP. 
• 51.2.2 a list of the samples and types to be exported. 
• 51.2.3 copy of the positive opinion of the EC (REC or LEC) and RCMOHP (if applicable). 
• 51.2.4 a document evidencing the payment of a fee specified in the Tariff."

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

From the research conducted, no specific guidance was available to address this point.

However, the guidance that exists for the Emirate of Dubai may be followed. Dubai Health Authority’s Health Regulation Sector issued a Health Information Policy on 26 December 2022 entitled “Policy for Health Information Assets Management”. Clause 4.6 of the Policy sets out detailed storage requirements for the storage of pathology, surgical pathology, genetics, and cytology samples and data.

6.3 Does the local authority require any specific documents for customs clearance?

Advice may be sought from the Ministry of Health and Prevention in relation to the import and export of drugs and biological specimens via Import.Export@mohap.gov.ae.