31st October 2005 ~ European legislation permits "Market Authorisation" to be bypassed in exceptional, objective and verifiable circumstances
"Market Authorisation" is a licence to market a medicine, granted in the UK by the Licensing Authority or in Europe by the European Medicines Evaluation Agency.
On 23 March 2004 Owen Paterson asked Ben Bradshaw whether it is possible "to use vaccines without their undergoing the full market authorisation process. "
Mr. Bradshaw replied at length but it emerged that
"....European legislation permits provisional marketing authorisations to be granted, in exceptional, objective and verifiable circumstances, without the need for a full data dossier. Such authorisations are only granted where safety has been established and are subject to specific conditions, such as the carrying out of further studies for efficacy." (Hansard)What is even more interesting, this 2002-2003 NAO report on page 9 of 54, point 18, says that although vaccines routinely administered in UK are required to have Market Authorisation the Government had allowed the smallpox vaccine to be administered without market authorisation. In the case of the PowderJect affair, an indemnity against any damages to the value of #30 million had been taken out by the government.
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