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Special Access Routes (SAR)

In specific situations, we may allow the import or the supply of Class 2 cell, tissue or gene therapy products (CTGTP) via Special Access Routes (SAR).

Import and supply of unregistered Class 2 CTGTP The import and supply of unregistered Class 2 CTGTP at the request of qualified practitioners for use on their patients will require approval from us. Import and supply of CTGTP on consignment basis Importers or wholesalers who are neither registrants nor authorised by the registrant, need approval to import and supply a registered Class 2 CTGTP.

Last updated: 31 Dec 2018