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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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Patrick Lyon
reviewed Guide To Eu Pharmaceutical Regulatory Law on March 25, 2017
Guide To Eu Pharmaceutical Regulatory Law
Tehehe-I WANT! :D
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