II.B.4.3. PSMF section on the sources of safety data

The description of the main units for safety data collection should include all parties responsible, on a global basis, for solicited and spontaneous case collection for products authorised in the EU. This should include medical information sites as well as affiliate offices and may take the form of a list describing the country, nature of the activity and the product(s) (if the activity is product specific) and providing a contact point (address, telephone and e-mail) for the site. The list may be located in the Annexes of the PSMF. Information about third parties (licence partners or local distribution/marketing arrangements) should also be included in the section describing contracts and agreements (see II.B.4.2. and II.B.4.8.).

Flow diagrams indicating the main stages, timeframes and parties involved may be used. However represented, the description of the process for ICSRs from collection to reporting to competent authorities should indicate the departments and/or third parties involved.

For the purposes of inspection and audit of the pharmacovigilance system, sources include data arising from study sources, including any studies, registries, surveillance or support programmes sponsored by the marketing authorisation holder through which ICSRs could be reported. MAHs should be able to produce and make available a list of such sources to support inspection, audit and QPPV oversight. In the interests of harmonisation, it is recommended that the list should be comprehensive for products authorised in the EU, irrespective of indication, product presentation or route of administration. The list should describe, on a worldwide basis, the status of each study/programme, the applicable country(ies), the product(s) and the main objective. It should distinguish between interventional and non-interventional studies and should be organised per active substance. The list should be comprehensive for all studies/programmes and should include ongoing studies/programmes as well as studies/programmes completed in the last two years and may be located in an Annex or provided separately.