III.C.4. Role of the Member States
III.C.4.1. General considerations
Member States should establish the legal and administrative framework within which pharmacovigilance inspections operate, including the definition of the rights of inspectors for inspecting pharmacovigilance sites and access to pharmacovigilance data.
Member States should provide sufficient resources and appoint adequately qualified inspectors to ensure effective determination of compliance with good pharmacovigilance practice. The inspector(s) appointed may be accompanied, when needed, by expert(s) on relevant areas. A Member State may also request assistance from another Member State, in which case, access to the inspection sites and data by the Member State providing assistance is desirable.
Pharmacovigilance inspections should be planned, coordinated, conducted, reported on, followed-up and documented in accordance with inspection procedures consistent with agreed Union pharmacovigilance inspection procedures developed by the PhVIWG to support harmonisation for the mutual recognition of pharmacovigilance inspections within the EU as mentioned in section III.B.5.
The scheduling and conduct of these inspections will be driven by the preparation of inspection programmes based on a systematic and risk-based approach as outlined in III.B.2. and III.C.3.3.
The national competent authorities, when preparing inspection programmes, should verify the inspection status of the marketing authorisation holders they plan to inspect by considering the information shared on planned or conducted inspections under the programmes in other Member States in order to assure coordination of inspection activities, prevent unnecessary duplication and to make the most efficient use of inspection resources.
When the pharmacovigilance system a national competent authority plans to inspect is the same as that already inspected by another national competent authority, sharing of information on the scope and outcomes of previous inspections and consideration of the national supervisory requirements, can help to define the objective, scope and timing of that national inspection.
A common repository, accessible to all Member States, the Agency and the Commission, should be created to facilitate this information sharing on pharmacovigilance inspections.
III.C.4.2. Role of the supervisory authority
The concept of the supervisory authority applies only in relation to centrally authorised products. According to Article 18 of Regulation (EC) 726/2004, the supervisory authority for the conduct of pharmacovigilance inspections shall be the competent authority of the Member State in which the pharmacovigilance system master file is located.
The supervisory authorities for pharmacovigilance are responsible for verifying on behalf of the Union that the marketing authorisation holder for the medicinal product satisfies the pharmacovigilance requirements laid down in Directive 2001/83/EC and Regulation 726/2004/EC. They may, if this is considered necessary, conduct pre-authorisation inspections to verify the accuracy and successful implementation of the existing or proposed pharmacovigilance system [REG Art 19].
Where the sites selected to be inspected are located outside the EU, the same supervisory authority as above will be responsible for the inspection on behalf of the Union. Where relevant or on request, and in particular for product-specific issues, the inspection may be conducted or assisted by inspector(s) from the Rapporteur or Co-Rapporteur Member State and/or expert(s) from the Rapporteur or CoRapporteur Member State or from other Member States as appropriate.
III.C.4.3. Inspection programmes
A programme for routine inspections for centrally authorised products will be determined by the Agency in conjunction with the supervisory authorities of the Member States, the PhVIWG, the PRAC and the CHMP. These inspections will be prioritised based on the potential risk to public health, considering the factors listed in III.B.5.. As a general approach, a marketing authorisation holder should be inspected on the basis of risk-based considerations, but at least once every 4 years.
If the same pharmacovigilance system is used for a variety of authorisation types (centralised and national, mutual recognition and decentralised), then the results of a supervisory authority inspection may be applicable for all products covered by that system. This routine inspection programme will be separate from any “for cause” inspections, but if a “for cause” inspection takes place it may replace the need for one under this programme, dependent on its scope.
Member States are also responsible for the planning and coordination of pharmacovigilance inspections within their territory in relation to products authorised nationally or via the mutual recognition or decentralised procedures in order to ensure compliance with the legislation within their own Member States and to verify the effectiveness of the marketing authorisation holder’s pharmacovigilance system at national level.
As indicated in III.C.3.1., based on the information from other inspections, the national competent authority will prioritise the inspections in its national programme and will use the information for the preparation of an appropriate scope for the national inspection. For example, national competent authorities may seek to verify the fulfilment of requirements concerning the national implementation of specific risk-minimisation measures, national communications concerning safety, locally conducted safety studies, or issues linked to national health care systems. A broader examination of pharmacovigilance applied to particular products of national interest may also be appropriate if this was not covered within the scope of a supervisory authority inspection.