Guide to EU Pharmaceutical Regulatory Law. 4th edition

In the European Union and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage.

Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following:

- obtaining a marketing authorisation;

- stages and standards for creating a product dossier;

- clinical trials;

- how and when an abridged procedure can be used;

- criteria for conditional marketing authorisations;

- generic products and ‘essential similarity’;

- paediatric use and the requisite additional trials;

- biologicals and ‘biosimilars’;

- homeopathic and herbal medicines;

- reporting procedures;

- pharmacovigilance;

- parallel trade;

- relevant competition law and intellectual property rights; and

- advertising.

In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included.

Contents:

+ About the Editor and Authors.

+ Foreword.

+ List of Terms and Abbreviations.

+ CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements.

+ CHAPTER 2 Clinical Trials.

+ CHAPTER 3 Obtaining a Marketing Authorisation.

+ CHAPTER 4 Conditional Marketing Authorisations.

+ CHAPTER 5 Supplementary Protection Certificates.

+ CHAPTER 6 Paediatrics.

+ CHAPTER 7 Advertising Medicinal Products for Human Use.

+ CHAPTER 8 Pharmacovigilance.

+ CHAPTER 9 Variations to Marketing Authorisations.

+ CHAPTER 10 Combination Products.

+ CHAPTER 11 Abridged Procedure.

+ CHAPTER 12 Orphan Drug Protection.

+ CHAPTER 13 Biologicals.

+ CHAPTER 14 Homeopathic, Herbal, and Traditional Herbal Medicinal Products.

+ CHAPTER 15 Advanced Therapy Medicinal Products.

+ CHAPTER 16 Medical Devices.

+ CHAPTER 17 Parallel Trade.

+ CHAPTER 18 Competition Law in the Pharmaceutical Sector.

+ Appendices.

++ APPENDIX 1 Useful Links.

++ APPENDIX 2 An Example of an SmPC – For Atenolol.

++ APPENDIX 3 An Example of a SUSAR Form.

++ APPENDIX 4 An Example of a Trial Protocol.

++ APPENDIX 5 Required Table of Contents for the Investigator’s Brochure.

+ Table of Cases.

+ Directives.

+ Other Legislation.

+ Regulations.

+ Index.

• Primary Source