II.B.4.5. PSMF section on pharmacovigilance processes

An essential element of any pharmacovigilance system is that there are clear written procedures in place. GVP Module I describes the required minimum set of written procedures for pharmacovigilance. A description of the procedural documentation available (standard operating procedures, manuals, at a global and/or National level etc.), the nature of the data held (e.g. the type of case data retained for ICSRs) and an indication of how records are held (e.g. safety database, paper file at site of receipt) should be provided in the PSMF.

A description of the process, data handling and records for the performance of pharmacovigilance, covering the following aspects shall be included in the PSMF:

• Continuous monitoring of product risk-benefit profile(s) applied and the result of evaluation and the decision making process for taking appropriate measures; this should include signal generation, detection and evaluation. This may also include several written procedures and instructions concerning safety database outputs, interactions with clinical departments etc;
• Risk management system(s) and monitoring of the outcome of risk minimisation measures; several departments may be involved in this area and interactions should be defined in written procedures or agreements;
• ICSR collection, collation, follow-up, assessment and reporting; the procedures applied to this area should clarify what are local and what are global activities;
• PSUR scheduling, production and submission, if applicable (see GVP Module VII);
• Communication of safety concerns to consumers, healthcare professionals and the competent authorities;
• Implementation of safety variations to the summary of product characteristics (SmPC) and patient information leaflets; procedures should cover both internal and external communications [based on IR Art 2(4)].

In each area, the marketing authorisation holder should be able to provide evidence of a system that supports appropriate and timely decision making and action.

The description must be accompanied by the list of processes referred to in Article 11(1) of Commission Implementing Regulation (EU) No 520/2012 under the topic compliance management, as well as interfaces with other functions. Interfaces with other functions include, but are not limited to, the roles and responsibilities of the QPPV, responding to competent authority requests for information, literature searching, safety database change control, safety data exchange agreements, safety data archiving, pharmacovigilance auditing, quality control and training. The list, which may be located in the Annexes, should comprise the procedural document reference number, title, effective date and document type (for all standard operating procedures, work instructions, manuals etc.). Procedures belonging to service providers and other third parties should be clearly identified. Documents relating to specific local/country procedures need not be listed, but a list may be requested on a per country basis. If no or only some countries use specific local procedures, this should be indicated (and the names of the applicable countries provided).