Authorisation and certification
Process according to Austrian Medicinal Products Act
The following procedures are described on the subordinate pages:
- Inspection of Good Laboratory Practice (GLP) according to the Ordinance on GLP for Substances Relevant under Drug Law,
- Inspection of Good Manufacturing and Distribution Practices (GMP / GDP) at manufacturers, laboratories and distributors in accordance with the Medicines Act and the Blood Safety Act,
and the issuing of authorisations, GLP and GMP certificates.
Further procedures for authorisation
- The additional requirements of the Blood Safety Act must be taken into account when approving blood establishments.
- Tissue establishments are licensed in accordance with the Tissue Safety Act.
What powers do inspectors have in the course of a company audit?
Inspectors shall have the right to enter, inspect and inspect premises and to take samples in the quantities necessary for an inspection, without compensation, as part of a business audit. In addition, they may inspect all records of the company to be kept in accordance with pharmaceutical regulations and make copies, photographs and video recordings of them in the company (the legal basis can be found in the relevant material laws).
Our company has a need for support in the implementation of draft laws in our QM landscape. Can the Inspectorate act as a consultant here?
The BASG offers the inspection of a design qualification to verify plans/projects/changes. The inspection of a design qualification takes place "virtually" on the basis of the planning documents.
The design qualification is charged in accordance with the ordinance of the BASG on the fee schedule in accordance with the GESG.
What significance and impact do inspections by third country authorities have in Austrian pharmaceutical companies?
Third-country authorities usually verify compliance with their manufacturing or clinical trial rules during their inspections. Neither the triggers of such inspections are known, nor are there any agreements on content with the BASG. They are therefore not suitable for comparison with inspection results of the BASG and are of no legal significance for the BASG.
In the event that hazardous practices are identified by the third country authority and reported to the BASG, the BASG is obliged to initiate corresponding activities.