Marketing Authorisation and Certification in the EU
- Definition in contrast to other classes of products (medical devices, cosmetics, foodstuffs)
- National marketing authorisation procedures in Germany, post-marketing authorisation
- Centralised and decentralised procedures of both the European Medicines Agency Products (EMA) in London and the European Commission
- Impact on licence contracts
- Certification procedures for medical devices in the European Union
- Formal legal remedies
- Specific requirements for genetically engineered medicinal products
- Regulatory matters related to company mergers