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Guide to EU pharmaceutical regulatory law / edited by Sally Shorthose.
2012
G 25 SHO.G
Available at WIPO Library
Items
Details
Title
Guide to EU pharmaceutical regulatory law / edited by Sally Shorthose.
Edition
Third edition.
Description
xlix, 640 pages : illustrations ; 25 cm
ISBN
9789041139016
904113901X paperback
904113901X paperback
Alternate Call Number
G 25 SHO.G
Note
"Wolters Kluwer Law & Business."
Aan de voet van de titelp.: Wolters Kluwer Law & Business.
Aan de voet van de titelp.: Wolters Kluwer Law & Business.
Bibliography, etc. Note
Includes bibliographical references and index.
Formatted Contents Note
1. Overview of European pharmaceutical regulatory requirements; 2. Clinical trials; 3. Obtaining a marketing authorization; 4. Conditional marketing authorizations; 5. Supplementary protection certificates; 6. Paediatrics; 7. Advertising medicinal products for human use; 8. Pharmacovigilance; 9. Variations to marketing authorizations; 10. Combination products; 11. Abridged procedure; 12. Orphan drug protection; 13. Biologicals; 14. Homeopathic, herbal, and traditional herbal medicinal products; 15. Advanced therapy medicinal products; 16. Medical devices; 17. Parallel trade; 18. Competition law in the pharmaceutical sector.
Published
Alphen aan den Rijn, The Netherlands : Kluwer Law International, 2012.
Language
English
Record Appears in
all
Added Corporate Author
Bird & Bird Llp.