Pharmaceuticals Law – Fields of Competence:

Subject of the pharmaceuticals law are all contents anchored in the German Pharmaceuticals Act. Due to European legislation harmonization, the European pharmaceutical law - including the guidelines - is of great importance as well. Special ordinances (e.g. AMWHV, GCP-V) complement the German pharmaceuticals law. In addition to those, the provisions of the German Act on Medication Advertising have to be obeyed. In the area of reimbursement, the SGB V is decisive for the economic success of a company.

Fields of Competence:

• Pharmaceuticals law counseling
  
  • Marketing authorization
  • Data protection of the dossier
  • Manufacturing
  • Clinical trials
  • Import of foreign pharmaceuticals
  • Compassionate use
  • Orphan drugs
  • Distribution
• Accompaniment in discussions with authorities
  
  • Legal issues concerning authorizations (e.g. marketing authorization, manufacturing authorization, whole sellers' authorization)
  • Pharmaceutical expertise to reinforce argumentations towards authorities
• Contract negotiations assistance
  
  • Outsourcing
  • Agreement on the division of responsibilities
  • Distribution
  • Cooperations
  • Investigators' contracts
  • CRO contracts
• Development of strategies
  
  • Data protection, generic developments
  • Distribution
  • Reviewing of marketing strategies
  • Reviewing of cooperations
• Reimbursement of pharmaceuticals in the Statutory Health Insurance (SHI)
  
  • Off-label use
  • OTC list of exceptions of reimbursement
  • Transparency Directive (Directive 89/105/EEC)
  • SHI physicians' recourses
  • Decisions and directives of the Federal Joint Committee
  • Fixed maximum amounts of reimbursement
• Pharmaceuticals liability
  
  • Defense against unjustified liability claims in compliance with §§ 84 ff. AMG
  • Defense against unjustified information rights claims in compliance with § 84a AMG
• Pharmaceuticals crime law, anti-corruption legislation, compliance