II.B.3. The representation of pharmacovigilance systems

The PSMF, as per definition in Article 1(28e) of Directive 2001/83/EC, shall describe the pharmacovigilance system for one or more medicinal products of the marketing authorisation holder. For different categories of medicinal products the marketing authorisation holder may, if appropriate, apply separate pharmacovigilance systems. Each such system shall be described in a separate PSMF. Those files shall cumulatively cover all medicinal products of the marketing authorisation holder for which a marketing authorisation has been issued in accordance with Directive 2001/83/EC or an authorisation has been granted in accordance with Regulation (EC) No 726/2004.

• It is anticipated that there will be circumstances where a single marketing authorisation holder may establish more than one pharmacovigilance system e.g. specific systems for particular types of products (vaccines, consumer health, etc.), or that the pharmacovigilance system may include products from more than one marketing authorisation holder. In either case, a single and specific PSMF shall be in place to describe each system.
• In accordance with Articles 8 and 104 of Directive 2001/83/EC, a single QPPV shall be appointed to be responsible for the establishment and maintenance of the pharmacovigilance system described in the PSMF.
• Where a pharmacovigilance system is shared by several marketing authorisation holders each marketing authorisation holder is responsible ensuring that a PSMF exists to describe the pharmacovigilance system applicable for his products. For a particular product(s) the marketing authorisation holder may delegate through written agreement (e.g. to a licensing partner or contractor) part or all of the pharmacovigilance activity for which the marketing authorisation holder is responsible. In this case the PSMF of the marketing authorisation holder may cross refer to all or part of the PSMF managed by the system of the party to whom the activity has been delegated subject to agreement on access to that system’s information for the marketing authorisation holder and the authorities. The marketing authorisation holder should be able to assure the content of the referenced file(s) in relation to the pharmacovigilance system applicable to their product(s). Activities for maintaining the PSMF in a current and accessible state can be delegated.
• Where applicable, a list of all PSMFs held by the same marketing authorisation holder shall be provided in the annex (see II.B.4.8.) [IR Art 3(7)]; this includes their location(s), details of the responsible QPPV(s) and the relevant product(s).
• Submission of summary information to competent authorities cannot contain multiple locations for a single PSMF. The address of the location of the PSMF provided to fulfil the requirement of Article 8(3) of Directive 2001/83/EC (and within the Article 57 database) should be an office address which reflects either the site in the EU where the main pharmacovigilance activities of the marketing authorisation holder are performed or the site where the qualified person responsible for pharmacovigilance operates. This address may be different to that of the applicant/marketing authorisation holder, for example, a different office of the marketing authorisation holder or when a third party undertakes the main activities.
• Similarly, the QPPV details aligned to a product in the Article 57 database may be those of a contract QPPV responsible for the pharmacovigilance system for a particular medicinal product, and not necessarily a QPPV directly employed by the marketing authorisation holder.
• When delegating any activities concerning the pharmacovigilance system and its master file, the marketing authorisation holder retains ultimate responsibility for the pharmacovigilance system, submission of information about the PSMF location, maintenance of the PSMF and its provision to competent authorities upon request [IR Art 6]. Detailed written agreements describing the roles and responsibilities for PSMF content, submissions and management, as well as to govern the conduct of pharmacovigilance in accordance with the legal requirements, should be in place [based on IR Art 6].
• When a pharmacovigilance system is shared, it is advised that the partners agree on how to mutually maintain the relevant sections within their own PSMFs. Accessibility of the PSMF to all the applicable marketing authorisation holder(s), and its provision to competent authorities should be defined in written agreements. It is vital that marketing authorisation holder(s) can gain assurance that the pharmacovigilance system used for its products is appropriate and compliant.