Guide to EU Pharmaceutical Regulatory Law: Annual Manual
Author:   Sally Shorthose
Publisher:   Kluwer Law International
ISBN:  

9789041128454


Pages:   656
Publication Date:   01 June 2010
Format:   Paperback
Availability:   In Print   Availability explained
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

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Guide to EU Pharmaceutical Regulatory Law: Annual Manual


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Full Product Details

Author:   Sally Shorthose
Publisher:   Kluwer Law International
Imprint:   Kluwer Law International
Dimensions:   Width: 23.40cm , Height: 3.70cm , Length: 15.60cm
Weight:   1.002kg
ISBN:  

9789041128454


ISBN 10:   904112845
Pages:   656
Publication Date:   01 June 2010
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Out of Print
Availability:   In Print   Availability explained
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

Table of Contents

Foreword. List of Terms and Abbreviations. 1. Overview of European Pharmaceutical Regulatory Requirements. 2. Obtaining a Marketing Authorisation. 3. Pharmacovigilance. 4. Clinical Trials. 5. Obtaining a Marketing Authorisation: Abridged Procedure. 6. Conditional Marketing Authorisations. 7. Variations to Marketing Authorisations. 8. Paediatrics. 9. Combination Products. 10. Biologicals. 11. Orphan Drug Protection. 12. Homeopathic, Herbal, and Traditional Herbal Medicinal Products. 13. Medical Devices. 14. Parallel Trade Limitations. 15. Competition Law in the Pharmaceutical Sector. 16. Advertising Medicinal Products for Human Use. Cases. Directives. Other Legislation. Regulations.

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