The Annex to Directive 81/852/EC is amended by the Annex of this Directive. The new Annex establishes that the applicant must demonstrate that the veterinary medical product is manufactured in accordance with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products and its updates, published by the European Commission in Volume 7 of its publication "The rules governing medicinal products in the European Union".