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Bio_pete

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Bio_pete

Re: surf_baron post# 4529

Friday, 02/16/2007 9:50:56 AM

Friday, February 16, 2007 9:50:56 AM

Post# of 6490
The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicinal products for human use.

The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing applications from persons or companies seeking 'orphan medicinal product designation' for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union.

The COMP actually makes the decision regarding marketing approval. So I think the March meeting 7th & 8th are the important dates.
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