This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the Agency. How the systems of these organisations interact while undertaking specific pharmacovigilance processes is described in each respective Module of GVP.

The definition of a pharmacovigilance system is provided in Article 1 of Directive 2001/83/EC as a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. The Agency likewise maintains a pharmacovigilance system to fulfil its pharmacovigilance activities.

For performing their pharmacovigilance activities, marketing authorisation holders, competent authorities of Member States and the Agency shall establish and use quality systems that are adequate and effective for this performance. The legal requirement for quality systems was introduced by Directive 2010/84/EU amending Directive 2001/83/EC (the latter is referenced as DIR) and Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004 (the latter is referenced as REG) to strengthen pharmacovigilance in the EU. The minimum requirements of these quality systems are set out in the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC (the Implementing Regulation is referenced as IR).

While there has to be compliance with these legal requirements, the implementation of a quality system should be adapted to the respective organisation.

By following the overall quality objectives in I.B.4. and the guiding principle in I.B.5. to meet the needs of patients, healthcare professionals and the public in relation to the safety of medicines, the application of the quality system should be adapted to how crucial each pharmacovigilance task is for fulfilling the quality objectives for each medicinal product covered by a quality system.

The guidance on quality systems in this Module is consistent with the general principles of the ISO 9000 Standards on good quality management practices, specifically the ISO 9001-2008 Standards on quality management systems, issued by the International Organization for Standardization (ISO). The general application of quality management to pharmacovigilance systems is described under I.B. and requirements specific to the operation of the EU network in I.C.

In this Module, all applicable legal requirements are referenced in the way explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.