• British Pharmacopoeia Volume I & II
  • Monographs: Medicinal and Pharmaceutical Substances

Products with Risk of Transmitting Agents of Animal Spongiform Encephalopathies

European Union chaplet of stars
General Notices

(Ph. Eur. monograph 1483)

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Definition

Products with risk of transmitting agents of animal spongiform encephalopathies are those derived from tissues or secretions of animals susceptible to transmissible spongiform encephalopathies other than by experimental challenge. This monograph applies to all substances or preparations obtained from such animals and to all substances or preparations where products obtained from such animals are included as active substances or excipients or have been used during production, for example as raw or source materials, starting materials or reagents.

PRODUCTION

Production complies with chapter (5.2.8) Minimising the risk of transmitting animal spongiform encephalophathy agents via human and veterinary medicinal products.

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