TSE requirements for imported unlicensed human medicines
Guidance for importers of unlicensed human medicines on meeting the requirements of the TSE (Transmissible Spongiform Encephalopathies) guidelines.
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Importers of certain unlicensed medicines must comply with The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 (Statutory Instrument 2003 No.1680).
This guidance covers:
- assessing compliance of prospective imports of exempt imported products
- products acceptable by default
- products requiring additional information