A pharmacovigilance inspection serves to check the marketing authorisation holder for the existence of facilities, processes and competences that are necessary for a functioning pharmacovigilance system, as well as to identify potential health risks for the public and, as a result, to implement appropriate measures.

On behalf of the Federal Office for Safety in Health Care, the AGES Medical Market Surveillance Institute carries out periodic inspections of pharmacovigilance systems in Austria to check compliance with Austrian and European pharmacovigilance regulations.

Periodic company inspections in accordance with the AMG (GMDP, PV), TAMG (GMDP, PV), BSG, GSG and SMG are processed via the Inspections & Monitoring eService. Deviations are currently still possible in individual cases after consultation.

The marketing authorisation holder of a medicinal product is obliged to operate a functioning, legally compliant pharmacovigilance system for its medicinal products and to ensure a prompt and adequate response to medicinal product-related emergencies with a health risk, even outside office hours. There is no immediate obligation to enable patients or customers to contact the company directly around the clock, but in an emergency it must be clear to them how to proceed (e.g. by setting up a mailbox or a clearly recognisable, regularly retrieved PV email address).

The Austrian Medicinal Products Act (AMG) and Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and the Austrian Veterinary Medicinal Products Act (TAMG) provide the legal basis for the operation of a pharmacovigilance system and the review of the requirements by the BASG. These documents also contain references to the guidelines on good pharmacovigilance practices (Good Pharmacovigilance Practices, GVP or Veterinary good pharmacovigilance practices, VGVP).
See also: Further information

As of 1 February 2016, changes to the summary of the pharmacovigilance system and changes to the QPPV (including contact details) and / or changes to the location of the Pharmacovigilance System Masterfile (PSMF) have to be notified through the Article 57 database only without the need for any further variation. Upon a change in the QPPV or location of the PSMF, the article 57 database should be updated by the MAH immediately to allow continuous supervision by the competent authorities.

Additionally it is recommended for MAHs to announce a local contact person for pharmacovigilance and to inform the Federal Office for Safety in Health Care by e-mail or letter. Furthermore, according to the Austrian Medicines Act, the Federal Office for Safety in Health Care may nominate an additional locally based person responsible for pharmacovigilance (national pharmacovigilance responsible person). However, this is only done in justified situations that require such a separate approach/construction.

MAHs with their PSMF in Austria are the main candidates for a pharmacovigilance inspection. As preparation and basis for pharmacovigilance inspections, the complete, up-to-date PSMF is requested by the inspectorate.

However, the Federal Office for Safety in Health Care is obliged to inspect all MAHs in Austria.
Local subsidiaries of global pharmaceutical companies are obliged to be prepared for inspections anytime and provide the relevant parts of the PSMF on demand.

The selection of candidates is a risk-based process. Selection criteria include, for example, the extent of actual pharmacovigilance activities in Austria (number of cases/PSUR statistics), requirements from RMPs, service provider activities, etc.

Another selection criterion for an inspection may be feedback from other departments of the Inspectorate or from the institutes Marketing Authorization of Medicinal Products & Lifecycle Management or Assessment & Analytics.

In Austria, there are routine inspections and triggered inspections performed. During routine inspections, it is examined whether the MAH´s PV system is fulfilling the legal requirements basically. In triggered inspections, the PV system is examined with reference to certain issues (e.g. non-compliance with reporting obligations, major changes to the system, etc.).

In case of planned inspections, the MAH is informed approximately 6 weeks in advance, including an agenda, the estimated duration and a request for electronic submission of the basic pharmacovigilance documents no later than 2 weeks before the scheduled date. The documents serve for the planning and preparation of the inspection.

The process starts with an introduction by the inspectors, followed by interviews with the responsible persons and document review. At the end, all findings are communicated and already at this level possible misunderstandings can be clarified orally.

After 4 weeks, the MAH receives an initial inspection report for commenting within 4 weeks. The MAH is obliged to draw up an action plan including a timeline for the implementation of corrective and preventive measures (CAPAs). The report is finalized approximately 4 weeks after the MAH´s response and includes an assessment of the whole pharmacovigilance system and, if applicable, comments on the action plan. A re-inspection for checking the CAPA implementation is possible any time.

• processing status
• Regulation (EU) 1235/2010
• Directive 2010/84/EU
• GVP Modules
• Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
• Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down provisions for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (Text with EEA relevance)
• Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)