II.B.6. Pharmacovigilance system master file presentation

Location:
II.B.
In force from:
31.03.2017

The PSMF shall be continuously accessible to the QPPV [IR Art 7(2)] and to the competent authorities on request [REG Art 16(3a), DIR Art 23(4), IR Art 7]. The information shall be succinct, accurate and reflect the current system in place, which means that whatever format is used, it must be possible to keep the information up to date and, when necessary, to revise to take account of experience gained, technical and scientific progress and amendments to the legislative requirements [IR Art 4(1)]. Although provision of the document within 7 days of request by a competent authority is stated in Article 23(4) of Directive 2001/83/EC, marketing authorisation holders should be aware that immediate access to the PSMF may also be required by the competent authorities, at the stated PSMF location or QPPV site (if different).

II.B.6.1. Format and layout

The PSMF may be in electronic form on condition that a clearly arranged printed copy can be made available to competent authorities if requested [IR Art 5(3)]. In any format, the PSMF should be legible, complete, provided in a manner that ensures all documentation is accessible and allow full traceability of changes. Therefore, it may be appropriate to restrict access to the PSMF in order to ensure appropriate control over the content and to assign specific responsibilities for the management of PSMF in terms of change control and archiving.

The PSMF should be written in English (unless the marketing authorisation holder only holds approvals in one Member State when it can be written in the EU official language for that territory), indexed in a manner consistent with the headings described in this Module [IR Art 5(2)], and allow easy navigation to the contents. In general, embedded documents are discouraged. The use of electronic book-marking and searchable text is recommended. Documents such as copies of signed statements or agreements should be included as appendices and described in the index.

The documents and particulars of the PSMF shall be presented with the following headings and, if hardcopy, in the order outlined: Cover Page to include:

  • The unique number assigned by the EV System to the PSMF when the XEVPRM is processed in the XEVMPD (Article 57 database).
  • The name of the MAH, the MAH of the QPPV responsible for the pharmacovigilance system described (if different), as well as the relevant QPPV third party company name (if applicable).
  • The name of other concerned MAH(s) (sharing the pharmacovigilance system).
  • The list of PSMFs for the MAH (concerning products with a different pharmacovigilance system).
  • The date of preparation / last update.

The headings used in II.B.4. should be used for the main content of the PSMF. The minimum required content of the Annexes is outlined in II.B.4.8., and additional information may be included in the Annexes, provided that the requirements for the content of the main sections (II.B.1.-7.) are also met. The positioning of content in the Annexes is further outlined; the bulleted points are descriptions of possible content (and not required headings):

The qualified person responsible for pharmacovigilance, Annex A

  • The list of tasks that have been delegated by the QPPV, or the applicable procedural document
  • The curriculum vitae of the QPPV and associated documents
  • Contact details supplementary to those contained in Article 57 database, if appropriate

The Organisational Structure of the MAH, Annex B

  • The lists of contracts and agreements

Sources of safety data, Annex C

  • Lists associated with the description of sources of safety data e.g. affiliates and third party contacts

Computerised systems and Databases, Annex D

Pharmacovigilance Process, and written procedures, Annex E

  • Lists of procedural documents

Pharmacovigilance System Performance, Annex F

  • Lists of performance indicators
  • Current results of performance assessment in relation to the indicators

Quality System, Annex G

  • Audit schedules
  • List of audits conducted and completed

Products, Annex H

  • List(s) of products covered by the pharmacovigilance system
  • Any notes concerning the MAH per product

Document and Record Control, Annex I

  • Logbook
  • Documentation of history of changes for Annex contents, indexed according to the Annexes A-H and their content if not provided within the relevant annex itself.

Documentation to support notifications and signatures concerning the PSMF, as required. Where there is no content for an Annex, there is no need to provide blank content pages with headings, however, the Annexes that are provided should still be named according to the format described. For example, Annex E should not be renamed to Annex D in circumstances where no Annex concerning computerised systems and databases is used, Annex D should simply be described as ‘unused’ in the indexing, in order that recipients of the PSMF are assured that missing content is intended.