Can I import from an unlicensed or non-accredited tissue establishment in the EEA?
This advice relates only to the import of tissue / cells from an establishment which is not accredited because the EEA state has not implemented the Directives. If the establishment is not accredited because of some other reason, e.g. it has not applied for or failed to gain accreditation, then this should be considered on a case by case basis. We advise that you contact the HTA in this circumstance. As long as your establishment holds an import licence, it would be the responsibility of the Designated Individual and the Licence Holder to ensure that imported tissue or cells meet the relevant requirements of Directions 001/2006, 002/2007 and 004/2007. Your establishment must verify that consignments conform to these requirements upon receipt. Tissue / cells must not be released from quarantine until verification is complete. In particular, please refer to paragraph 115 of Directions 002/007 which details the traceability requirements.
Related Questions
- Do I need a licence to distribute and/or export tissue to a tissue establishment within an EEA (or EU) member state which has not yet implemented the Directives?
- Do I need a licence to import from a licensed or accredited tissue establishment within the EEA?
- Do I need a licence to import from outside the EEA?
