Guidance

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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 9 August 2005

Documents

TSE compliance requirements for exempt imported products

PDF, 85.4 KB, 4 pages

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Details

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