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Title:

Guide to EU pharmaceutical regulatory law / edited by Sally Shorthose.

Publisher:

Kluwer Law International,

Copyright Date:

2010

Description:

lvi, 672 pages ; 25 cm

Subject:

Drugs--Law and legislation--Law and legislation--European Union countries.
Drugs--Law and legislation--European Union countries.
Pharmacy--Law and legislation--European Union countries.

Other Authors:

Shorthose, Sally. http://id.loc.gov/authorities/names/no2010107679

Notes:

Includes bibliographical references and index.

Contents:

Overview of european pharmaceutical regulatory requirements / Sally Shorthose & Mary Smilie -- Obtaining a marketing authorisation / Sally Shorthose & Mary Smilie -- Pharmacovigilance / Mary Smilie & Gina Brueton -- Clinical trials / Sally Shorthose -- Obtaining a marketing authorisation : abridged procedure / Machteld Hiemstra -- Conditional marketing authorisations / Sally Shorthose & Victoria Evans -- Variations to marketing authorisations / Lorna Brazell -- Paediatrics / Sally Shorthose & Victoria Evans -- Combination products / Philipp Neels -- Biologicals / Victoria Evans -- Orphan drug protection / Victoria Evans -- Homeopathic, herbal, and traditional herbal medicinal products / Colette Mulder -- Medical devices / Ulf Grundmann & Jarste Akkermann -- Parallel trade / Ina vom Feld & Philipp Neels -- Competition law in the pharmaceutical sector / Morten Nissen, Geoffroy van de Walle de Ghelcke & Melanie Vilarasau -- Advertising medicinal products for human use / Mary Smillie ... [et al.].

ISBN:

904112845X
9789041128454

OCLC:

(OCoLC)657271183

LCCN:

2010483622

Locations:

OVUX522 -- University of Iowa Libraries (Iowa City)