Human Medicinal Products in the European Union: Procedures

This chapter addresses procedures for marketing authorisations both at EMA and national level for human medicines including herbals, and variations, procedures for orphan designation, paediatric investigation plans and waivers, referrals and pharmacovigilance.

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Bibliographic Details
Published inThe Textbook of Pharmaceutical Medicine pp. 379 - 417
Main Authors Raymond, Agnès Saint, Humphreys, Anthony J
Format Book Chapter
LanguageEnglish
Published Oxford, UK Blackwell Publishing Ltd 18.04.2013
Subjects
European Union
herbal medicines
orphan medicines
paediatric investigation plans
pharmacovigilance
referrals
risk management plans
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Summary:This chapter addresses procedures for marketing authorisations both at EMA and national level for human medicines including herbals, and variations, procedures for orphan designation, paediatric investigation plans and waivers, referrals and pharmacovigilance.
ISBN:9780470659878
0470659874
DOI:10.1002/9781118532331.ch20