The Pharmaceutical Journal
Vol 274 No 7351 p636
28 May 2005

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EU medicines law guidelines

Draft guidelines on European medicines legislation that comes into force on 20 November are being prepared by the European Commission.

At its April meeting, the European Medicines Agency Committee for Medicinal Products for Human Use approved documents that the commission will use to prepare the draft guidelines. These will then be put out to consultation for four weeks before adoption. The new guidelines will cover:

· The optional scope of the centralised licensing procedure for new medicines
· Conditional licensing before all clinical trials are complete
· Accelerated assessments
· Data exclusivity and market protection
· Compassionate use of unlicensed drugs
· Approval in exceptional circumstances
· Public assessment reports