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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Abstract 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.
AbstractList 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.
Author Raymond, Agnès Saint
Humphreys, Anthony J
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  surname: Humphreys
  fullname: Humphreys, Anthony J
  organization: Procedural and Committee Support, Patient Health Protection, European Medicines Agency, London, UK
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Copyright Copyright © 2013 John Wiley & Sons, Ltd
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DOI 10.1002/9781118532331.ch20
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Discipline Pharmacy, Therapeutics, & Pharmacology
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Snippet This chapter addresses procedures for marketing authorisations both at EMA and national level for human medicines including herbals, and variations, procedures...
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StartPage 379
SubjectTerms European Union
herbal medicines
orphan medicines
paediatric investigation plans
pharmacovigilance
referrals
risk management plans
Title Human Medicinal Products in the European Union: Procedures
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