Marketing authorisation & life-cycle

Marketing authorisation of medicinal products

Drug authorisation on the basis of the Austrian Drug Law is one of the main tasks of the Federal Office for Safety in Health Care (BASG). During the authorisation process, the experts check the efficacy, safety and quality of the drug. A medicinal product shall only be authorised if the existing risk-benefit profile is proportionate and the benefits outweigh the risks.

An authorisation is initially granted for a period of five years. Afterwards, a new application must be submitted to the BASG, on the basis of which the drug will be re-examined. If the result is positive, the extension takes place. Any changes to medicinal products must also be submitted to the BASG for approval.

 

Authorisation types

There are three marketing authorisation procedures for medicinal products in Europe:

  1. National authorisation procedure
  2. MRP / DCP process
  3. Central authorisation procedure
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