III.C.2. Role of the European Medicines Agency

III.C.2.1. General role of the Agency

Regarding the monitoring of compliance with regulatory pharmacovigilance obligations and pharmacovigilance inspections, the roles of the Agency are set out in Article 57(1)(c) and Article 57(1)(i) of Regulation (EC) No 726/2004 and can be summarised as follows:

• coordination of the monitoring of medicinal products for human use which have been authorised within the Union, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;
• coordination of the verification of compliance with pharmacovigilance obligations.

Pharmacovigilance inspections coordinated by the Agency are performed by the supervisory authority concerned as outlined in III.C.3.2. The supervisory authority may be assisted by other national competent authorities, when required.

As part of this coordination role the Agency is responsible for:

• establishing and maintaining processes through the PhVIWG to support the consistency and quality of pharmacovigilance inspections of marketing authorisation holders with centrally authorised products conducted by inspectorates of the national competent authorities;
• coordinating and ensuring the implementation of a risk-based programme for routine pharmacovigilance inspections of marketing authorisation holders with centrally authorised products (see III.B.2.) enabling the timely sharing of information on planned and conducted pharmacovigilance inspections between Member States, with the aim of reducing duplication of inspection activity and facilitating mutual recognition of inspection findings; • coordinating “for cause” inspections, as requested by the CHMP. If a “for cause” inspection has been or will be conducted in a similar timeframe as a routine one, it may replace the need for the planned routine inspection and the programme shall be revised to reflect this;
• coordinating third country inspections: according to Article 111(1) of the Directive 2001/83/EC, the Agency shall cooperate in the coordination of inspections in third countries. Member States should liaise with the Agency when the need for an inspection of a third country site is identified in order to ensure productive use of pharmacovigilance inspection resource in the interests of the Union;
• communication and follow-up of inspections of Union interest across the Agency, the PRAC, the CHMP, the CMD(h), the EU regulatory network and with third country regulators, whenever confidentiality arrangements are in place to facilitate this.

III.C.2.2. Role of the PRAC

The PRAC may make recommendations on the need and scope of “for cause” pharmacovigilance inspections related to medicinal products of Union interest.

The PRAC may, in relation to issues of Union interest and where considered appropriate, review the outcome of pharmacovigilance inspections and assess marketing authorisation holder-related corrective and preventive action plan submission(s) in order to make or endorse further recommendations on actions to be taken and their follow-up.

The PRAC is also responsible for providing input in the preparation of and agreeing on the risk-based programme for routine pharmacovigilance inspections of marketing authorisation holders with centrally authorised products outlined in III.B.2 and III.C.3.3.

III.C.2.3. Role of the CHMP

The CHMP is responsible for the request of pharmacovigilance inspections in the context of the centralised procedure and for the endorsement of the recommendations made by the PRAC in relation to the outcome of these inspections and their follow-up. The CHMP is also responsible for the adoption of the risk-based programme for routine pharmacovigilance inspections outlined in III.B.2. and III.C.3.3.