Please note:

From January 2025, registration in IRIS will be mandatory for all lifecycle procedures managed by the EMA. It is important to note that nationally or decentrally authorised products may also be affected, e.g. for worksharings with NAPs/MRPs/DCPs and CAPs, single assessments of PSURs, referrals and post-authorisation safety studies. Therefore, please make sure that your company also applies for access to IRIS in good time, even if you do not have any centralised authorisations.

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