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.


TSE compliance requirements for exempt imported products

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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
Published 9 August 2005