CONDITIONAL MARKETING APPROVAL
December 1st, 2004
BY KEITH NUTHALL
THE EUROPEAN Commission has proposed allowing fast-track conditional marketing authorisations for medicines treating serious, chronic or life-threatening diseases. Its tabled regulation also covers designated orphan drugs and medicines for emergency situations recognised by the European Union or the World Health Organisation. It includes rules on renewing authorisations and insisting packaging declares these medicines are conditionally approved. *http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/draft-regulation_13-10-2005.pdf
THE EUROPEAN Commission has proposed allowing fast-track conditional marketing authorisations for medicines treating serious, chronic or life-threatening diseases. Its tabled regulation also covers designated orphan drugs and medicines for emergency situations recognised by the European Union or the World Health Organisation. It includes rules on renewing authorisations and insisting packaging declares these medicines are conditionally approved. *http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/draft-regulation_13-10-2005.pdf
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