Guideline on good pharmacovigilance practices (GVP) – Module II (Rev 2)
organisations and operational units relevant to the fulfilment of pharmacovigilance obligations. This
should include third parties. Specifically, the PSMF shall describe:
The organisational structure of the marketing authorisation holder(s), showing the position of the
QPPV in the organisation.
The site(s) where the pharmacovigilance functions are undertaken covering individual case safety
report collection, evaluation, safety database case entry, periodic safety update report production,
signal detection and analysis, risk management plan management, pre- and post-authorisation
study management, and management of safety variations to product particulars [IR Art 2(2)].
Diagrams may be particularly useful; the name of the department or third party should be indicated.
Delegated activities
The PSMF, where applicable, shall contain a description of the activities and/or services subcontracted
by the marketing authorisation holder [IR Art 2 (6)] relating to the fulfillment of pharmacovigilance
obligations. This includes arrangements with other parties in any country, Worldwide and if applicable,
to the pharmacovigilance system applied to products authorised in the EU.
Links with other organisations, such as co-marketing agreements and contracting of pharmacovigilance
activities should be outlined. A description of the location and nature of contracts and agreements
relating to the fulfilment of pharmacovigilance obligations should be provided. This may be in the form
of a list/table to show the parties involved, the roles undertaken and the concerned product(s) and
territories. The list should be organised according to: service providers (e.g. medical information,
auditors, patient support programme providers, study data management, etc.), commercial
arrangements (distributors, licensing partners, co-marketing etc.) and other technical providers
(hosting of computer systems etc.). Individual contractual agreements shall be made available at the
request of national competent authorities and the Agency or during inspection and audit and the list
provided in the Annexes (see II.B.4.8.).
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