Pharmacovigilance inspections are conducted to ensure that the marketing authorization holder (MAH) operates a functioning pharmacovigilance system for the fulfilment of his pharmacovigilance tasks. The Institute Surveillance carries out periodic inspections of pharmacovigilance systems in Austria on behalf of the Federal Office for Safety in Health Care in order to check compliance with Austrian and European pharmacovigilance legislation.
In July 2012, new EU pharmacovigilance legislation came into force, resulting from the implementation of Regulation (EU) 1235/2010 and Directive 2010/84/EU, which was implemented at national level in December 2012 with an amendment to the Austrian Medicines Act. The new legislation is reinforced by a series of Good Pharmacovigilance Practice (GVP) modules that regulate the implementation of pharmacovigilance activities. The first GVP modules came into force in July 2012, and further modules were published in the course of 2013/2014. The Austrian Medicines Act stipulates that the European guidelines on good pharmacovigilance practice (GVP) may be used as basis for pharmacovigilance procedures at national level.
Principles regarding pharmacovigilance inspections are described in the Austrian Medicines Act and the EU guidelines, in particular the GVP Module III (Pharmacovigilance Inspections).
The MAH is obliged to operate a functioning, legally compliant pharmacovigilance system and to ensure a prompt and adequate response to drug-related emergencies, even outside office hours. There is no obligation for implementing a direct contact point around the clock for the customer, but in case of an emergency, it must be clear for the customer how to proceed (e.g. by setting up a mailbox or a clearly identifiable, regularly accessed PV e-mail address).
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 8 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.