Written question asked by Lord Bellingham (Conservative) on Tuesday, 2 July 2002, in the House of Commons. It was due for an answer on Thursday, 11 July 2002. It was answered by Lord Hutton of Furness (Labour) on Thursday, 11 July 2002 on behalf of the Department of Health.

Dept of Health

Question: To ask the Secretary of State for Health, whether other bidders for the smallpox vaccine awarded to Powderject committed themselves to supply a vaccine that was free of BSE agents.

Answer: Mr. Bellingham: To ask the Secretary of State for Health whether other bidders for the smallpox vaccine awarded to Powderject committed themselves to supply a vaccine that was free of BSE agents. [67543] Mr. Hutton: Yes, other bidders for the smallpox vaccine awarded to Powderject committed themselves to supply a vaccine that was free of bovine spongiform encephalopathy (BSE) agents. European legislation demands that an application for marketing authorisation of a medicinal product in the European Union must include satisfactory demonstration of compliance with the European note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. If a manufacturer wishes to produce smallpox vaccine using virus culture in bovine cells, the appropriate regulatory guidance on cell characterisation and storage would have to be followed.

Secondary information