6. Biological Specimen

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

The rules relating to the export of biological shipment are covered in the Royal Decree 65/2006, of January 30, which establishes requirements for the import and export of biological samples. 

Art. 5.3 of the Spanish RD 65/2006 states the following:

“3. For the export of biological samples, the interested party must submit a statement to the General Directorate of Public Health containing the necessary information to identify the sample and its destination.

…

In the event that the destination health authority requires a health certificate of origin, this will be requested from the aforementioned General Directorate, which will establish the corresponding requirements in each case. This certificate will be issued automatically if the interested party is registered in the Registry of importers and exporters of biological samples."

Additional Information on the export and import requirements of biological samples can be found on the Spanish Ministry of Health website which provides links to the relevant forms and requirements for registration. See also below:

Registration of importers and exporters of biological samples

Importers or exporters of samples who regularly carry out import or export operations of biological samples may apply for registration in the voluntary register of importers and exporters of biological samples using the specific forms for the registration of importers or exporters of biological samples available on the electronic headquarters of the Ministry of Health.

This application must be accompanied by the following documentation:

• Annex III duly signed and stamped by the laboratory of origin, identifying the shipment, its characteristics, and the possible health risk, if any, or the Application for Registration document.
• If these samples are part of a clinical trial, registration must be requested by the sponsor of the trial, or where appropriate, its representative or a CRO, providing a letter of delegation of powers from the sponsor and the authorization of the Clinical Trial by the AEMPS.
• Accreditation of the importer's activity: the importing body must be sufficiently accredited according to its activity and comply with the occupational safety regulations applicable to these samples.

Importers and exporters registered in this Registry must renew the documentation every five years or update it when there is a change in the type of sample to be imported or exported or in the centers or countries and must submit a new application form for updating the Registry Update Document.

Failure to renew, as well as any variation in the type of samples, centers, and countries not authorized, will result in removal from the Register of Importers and Exporters.

Once the application for registration or update of the registration has been reviewed and all the necessary documentation has been provided, a resolution will be issued granting or, where appropriate, denying the incorporation in the register, a resolution that will be made available to the interested party on the electronic headquarters of the Ministry of Health.

Additionally, it is recommended to complete and submit within Part II of the application dossier the Annex XIII form, to establish regulatory compliance for the Management of Biological Samples.

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.

Separate consent is not required unless the collection of biological samples is specific for sub-studies or future studies. In this case, a separate consent is required. 

The AEMPS has published Annex VIIIB which provides paragraphs to be included in the Informed Consent Form for the collection and use of biological samples in clinical trials.

The paragraphs proposed in Annex VIIIB refer to the information that a patient must receive regarding the collection and use of biological samples and possible future use of excess samples, and should preferably be included in the general information sheet for the clinical trial (see Annex VIIIA to the document “Guideline for the correct preparation of a model patient information sheet and informed consent form”). Therefore, this guide document does not include the patient’s signature or the date. In the event of biological samples being obtained specifically for sub-studies or future studies, it is recommended that specific PIS/ICFs are created.

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

Documents and related procedures for the import and export of biological samples can be found on the Spanish Ministry of Health page (Biological samples).