II.B.4.2. PSMF section on the organisational structure of the marketing authorisation holder

A description of the organisational structure of the marketing authorisation holder relevant to the pharmacovigilance system must be provided. The description should provide a clear overview of the company(ies) involved, the main pharmacovigilance departments and the relationship(s) between 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.).