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."

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.

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.

We have not found evidence for a separate consent.

However, the Patient/Participant Information Sheet and Consent Form template published by the DHA provides the language required when biological samples are planned to be collected.

“19. What will happen to any samples I give?

Details of any tissue/fluid samples to be taken, what will happen to these where they will be stored, and for how long they will be stored? It should be clear to the participant, in the description of study procedures, whether 

1. New samples will be taken (e.g. blood, tissue, specifically for this study)
2. Samples excess to a clinical procedure will be asked for
3. Access to existing stored samples will be asked for.

The same type of information, as for data, is needed. This should include:

1. Who will have access?
2. The level of identifiability (for this study and for storage for future studies)
3. Provision for destruction
4. Procedures for possible feedback of individually significant information from their use.
5. Whether samples will be transferred outside the country.

20. Will any genetic tests be done?

Details of any genetic tests that will be undertaken must be explained to the patient. The DSREC recommends that, for genetic studies, information on possible individual implications, feedback, counseling, etc. should be clearly explained.”

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.