An annex to the PSMF shall contain the following documents:

  • A list of medicinal products covered by the PSMF including the name of the medicinal product, the international non-proprietary name of the active substance(s), and the Member State(s) in which the authorisation is valid [IR Art 3];

The list of medicinal products authorised in the EU should also include the authorisation number(s) including, per authorisation:

    • the type of procedure for authorisation and procedure number (e.g. centrally authorised, nationally authorised products, including those authorised through the mutual recognition or the decentralised procedure);
    • the Rapporteur country or Reference Member State;
    • the presence on the market in the EU [DIR Art 23(a), REG Art 13(4)];
    • other (non EU) territories where the product is authorised or on the market

The list should be organised per active substance and, where applicable, should indicate what type of product specific safety monitoring requirements exist (for example risk minimisation measures contained in the risk management plan or laid down as conditions of the marketing authorisation, non-standard PSUR periodicity, referral under Article 31 of Directive 2001/83/EC, or included in the list described in Article 23 of Regulation (EC) No 726/2004). The monitoring information may be provided as a secondary list.

For marketing authorisations that are included in a different pharmacovigilance system, for example, because the MAH has more than one pharmacovigilance system or third party agreements exist to delegate the system, reference to the additional PSMF(s) should also be provided as a separate list in the Annexes, such that, for a MAH, the entire product portfolio can be related to the set of PSMFs.

Where pharmacovigilance systems are shared, all products that utilise the pharmacovigilance system should be included, so that the entire list of products covered by the file is available. The products lists may be presented separately, organised per MAH. Alternatively, a single list may be used, which is supplemented with the name of the MAH(s) for each product, or a separate note can be included to describe the product(s) and the MAH(s) covered;

  • A list of written policies and procedures for the purpose of complying with Article 11(1) of Commission Implementing Regulation (EU) 520/2012 [IR Art 3(2)];
  • A list of contractual agreements covering delegated activities including the medicinal products and territory(ies) concerned in accordance with Article 6(2) of Commission Implementing Regulation (EU) No 520/2012 (see II.B.4.3.) [IR Art 3(3)];
  • A list of tasks that have been delegated by the qualified person for pharmacovigilance [IR Art 3(4)];
  • A list of all completed audits, for a period of five years, and a list of audit schedules [IR Art 3(5)];
  • Where applicable, a list of performance indicators in accordance with Article 9 of Commission Implementing Regulation (EU) No 520/2012 [IR Art 3(6)];
  • Where applicable, a list of other PSMFs held by the same marketing authorisation holder [IR Art 3(7)]; This list should include the PSMF number(s), and the name of MAH of the QPPV responsible for the pharmacovigilance system used. If the pharmacovigilance system is managed by another party that is not a marketing authorisation holder, the name of the service provider should also be included.
  • A logbook in accordance with Article 5(4) of Commission Implementing Regulation (EU) No 520/2012 [IR Art 3(8)]. Other change control documentation should be included as appropriate. Documented changes shall include at least the date, person responsible for the change and the nature of the change [IR Art 5(4)].