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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

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