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MLX 347 seeks your views on proposals to introduce measures in the UK to enforce the obligations set out in Regulation (EC) No. 1901/2006 (the Paediatric Regulation). The Paediatric Regulation introduces a framework for providing incentives to companies to conduct research into the use of medicines by children in the EU.
The deadline for comments was 18 April 2008.
Results of consultation
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Results of consultation on amendments to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994
(34Kb)
Download documents:
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The Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2008: SI 2008 No. 3097 (61Kb)
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Public consultation (MLX 347): Amendments to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994 - Consultation list (29Kb)
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Public consultation (MLX 347): Amendments to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994 (133Kb)
