6. Biological Specimen

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

The following general documentation must be provided to export cells, tissues, and products of human beings and their components:

1. Entry or Exit of Products of Human Beings form (see MEX-24).
2. Proof of payment of rights in original and two legible copies.
3. Letter of acceptance of the establishment abroad.
4. A legible copy of the authorization document issued by COFEPRIS for the protocol when it is intended for humans, or a summary of the study when in vitro is being carried out, where appropriate.
5. Copy of the operating notice or sanitary license.

See also MEX-62 for detailed documentation to be submitted to export cells, tissues, and products of human beings and their components intended for scientific research.

https://www.gob.mx/cms/uploads/attachment/file/652233/COFEPRIS-01-024.pdf

https://www.gob.mx/tramites/ficha/permiso-de-salida-de-territorio-nacional-de-celulas-y-tejidos-incluyendo-sangre-sus-componentes-y-derivados-asi-como-otros-productos-de-seres-humanos/COFEPRIS225

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.

Yes. The ICF must contain a specific clause indicating that specimens may be used in future research.

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

The following documentation should be included:

1. Authorizations, Certificates, and Visits Form (see MEX-25) (Original).
2. Proof of payment of fees (Original and two copies).
3. Health License or Notice of Operation (Original and one copy).
4. Approval from the research protocol office authorized by COFEPRIS and its amendments, only in the case of research on human beings (Original and one copy).

In addition, documents originating from a foreign country are to be presented in Spanish or, if in another language, with a Spanish translation made by an expert translator.

COFEPRIS has 10 days to approve the request. If COFEPRIS does not respond within this timeframe, the request is deemed approved. The maximum validity of import authorizations is 180 days, which may be extended for an equal period, provided the conditions in which they have been granted have not changed.