1. Regulating the EU Pharmaceutical Sector: A Multilayered Challenge 1. The Pharmaceutical Sector: A Need for Regulation 2. The Structure of the Pharmaceutical Industry in Europe 3. EU Competence in the Field of Public Health 4. Effective Legislation and Regulatory Rights 5. The Structure of the Book 2. Setting the Stage for Regulatory Rights: The Regulatory Agencies and the Marketing Authorisation Procedure 1.
Regulatory Authorities 2. The Marketing Authorisation Procedure 3. Concluding Remarks 3. Data Exclusivity 1. The Legal Framework 2. Clinical Data 3. The Marketing Authorisation Procedure and Directive 2001/83 - Original Pharmaceuticals 4. Marketing Authorisation for Generic Products 5.
The Weaknesses of the System 6. Data Exclusivity for Paediatric Medicines that are Not Patent-Protected 7. Concluding Remarks 4. The Supplementary Protection Certificate 1. Background to the Legal Framework 2. The Legal Framework 3. The Subject of Protection 4. The Rights Granted 5.
The SPC Beneficiary 6. Concluding Remarks 5. The Paediatric Extension 1. Background 2. The General Legal Framework 3. A New Committee to Implement the Legal Framework: The Role of the Paediatric Committee (PDCO) 4. The PIP 5. PIP Compliance Control 6.
Exemptions and Waivers 7. The Incentives of the Regulation 8. Rewards for Orphan Medicinal Products under Regulation 1901/2006 9. Other Incentives in the System 10. Post-approval Obligations 11. Concluding Remarks 6. Orphan Drugs 1. Background to the Legal Framework 2.
Procedural Aspects 3. The Criteria for Orphan Drugs Designation 4. Marketing Authorisation of Orphan Drugs 5. The Incentives of the Orphan Drug Designation 6. Post-grant Obligations of the Sponsor 7. Difficulties in the Interpretation of Orphan Drugs Regulation Case Law 8. Concluding Remarks 7. Advanced Therapy Medicinal Products 1.
The Legal Framework 2. Definitions of Key Terms in the ATMP Regulation 3. The ATMP Regulation and Other European Legislation 4. Marketing Authorisation for ATMPs 5. Post-authorisation Requirements 6. Concluding Remarks 8. How Effective is the Effectiveness Test in the Field of Regulatory Rights? 1. The Objectives 2.
The Contents 3. The Context 4. The Results 5. General Conclusions.