II.A. Introduction
The legal requirement for marketing authorisation holders to maintain and make available upon request a pharmacovigilance system master file (PSMF) was introduced by Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC (see Recitals (7) and (35), Article 23(4), Article 104(3)(b) of Directive 2010/84/EU) and Regulation (EU) No 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 (see Recitals (22) and (25), Article 16(3a) of Regulation (EU) No 1235/2010), to harmonise and strengthen the conduct of pharmacovigilance activities in the EU.
The PSMF definition is provided in Article 1(28e) of Directive 2001/83/EC and the minimum requirements for its content and maintenance 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 detailed requirements provided by the Commission Implementing Regulation are further supported by the guidance in this GVP Module.
Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 are hereinafter referred to as REG, DIR and IR, respectively.
The PSMF shall be located either at the site in the EU where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the EU where the qualified person responsible for pharmacovigilance operates [IR Art 7(1)].
It is a requirement of the marketing authorisation application that summary information about the pharmacovigilance system is submitted to the competent authorities [DIR Art 8(3)(ia)]. This summary includes information on the location of the PSMF (see II.B.2.1.).
This Module provides detailed guidance regarding the requirements for the PSMF, including its maintenance, content and associated submissions to competent authorities.
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”.