Market Introduction – Benefits Dossier (AMNOG)

On 1 January 2011, the Act on the Reform of the Market for Medicinal Products AMNOG came into effect, fully revising the regulation of pricing and reimbursement by the statutory health insurance funds for new medicinal products in Germany. For the first time, pharmaceutical entrepreneurs are required to submit a dossier about the benefits as soon as they bring a new medicinal product to market in Germany or gain authorisation for new indications. For authorised and marketed medicinal products an assessment of benefits can be required. Based on the marketing approval documentation and all trials conducted on the medicinal product, this dossier assesses whether the medicinal product offers an added benefit compared to appropriate pharmacological and therapeutic options.

The decision of the Joint Federal Committee (G-BA) concerning the added benefit a new medicinal product has to offer is the basis for the price the manufacturer can ask for the newly approved medicinal product in Germany.

In close strategic co-operation with our clients, our experts prepare a well thought-out and professionally precise benefits dossier that is persuasive and contributes to the economic success of your product.

We base our work on client data and conduct extensive literature searches after consulting with the client.


The services of s4s for market introduction and the benefits dossier include:

  • Dossier for the assessment of benefits, modules 1 - 5, single modules or subtasks:
  • Administrative information/summary
  • Information on the medicinal product/authorised indications
  • Appropriate comparator/patients with additional benefit/costs of therapy, quality-assured administration
  • Systematic overview of the medicinal benefit and additional benefit/patient groups with additional benefit
  • Detailed presentation and evaluation of clinical studies
  • Compilation of appendices
  • Literature searches in all relevant databases
  • Consulting regarding strategy and content