Table of Cases Table of Legislation 1. Regulating the EU Pharmaceutical Sector: A Multilayer Challenge 1. The Pharmaceutical Sector: A Need for Regulation2. The Structure of the Pharmaceutical Industry in Europe3. EU Competence in the Field of Public Health4. Effective Legislation and Regulatory Rights5. The Structure of the Book 2. Setting the Stage for Regulatory Rights: The Regulatory Agencies and the Marketing Authorisation Procedure 1.
Regulatory Authorities2. The Marketing Authorisation Procedure3. Concluding Remarks 3. Data Exclusivity 1. The Legal Framework2. Clinical Data3. The Marketing Authorisation Procedure and Directive 2001/83 - Original Pharmaceuticals4. Marketing Authorisation for Generic Products5.
The Weaknesses of the System6. Data Exclusivity for Paediatric Medicines That Are Not Patent-Protected7. Concluding Remarks 4. The Supplementary Protection Certificate 1. Background to the Legal Framework2. The Legal Framework3. The Subject of Protection4. The Rights Granted5.
The SPC Beneficiary6. Concluding Remarks 5. The Paediatric Extension 1. Background2. The General Legal Framework3. A New Committee to Implement the Legal Framework: The Role of the Paediatric Committee (PDCO)4. The PIP5. PIP Compliance Control6.
Exemptions and Waivers7. The Incentives of the Regulation8. Rewards for Orphan Medicinal Products Under Regulation 1901/20069. Other Incentives in the System10. Post-Approval Obligations11. Concluding Remarks 6. Orphan Drugs 1. Background to the Legal Framework2.
Procedural Aspects3. The Criteria for Orphan Drugs Designation4. Marketing Authorisation of Orphan Drugs5. The Incentives of the Orphan Drug Designation6. Post-Grant Obligations of the Sponsor7. Difficulties in the Interpretation of Orphan Drugs Regulation Case Law8. Concluding Remarks 7. Advanced Therapy Medicinal Products 1.
The Legal Framework2. Definitions of Key Terms in the ATMP Regulation3. The ATMP Regulation and Other European Legislation4. Marketing Authorisation for ATMPs5. Post-Authorisation Requirements6. Concluding Remarks 8. How Effective Is the Effectiveness Test in the Field of Regulatory Rights? 1. The Objectives2.
The Contents3. The Context4. The Results5. General Conclusions Bibliography Index.