The pharmacovigilance system master file shall contain at least all of the following elements:

1. (1)

   the following information relating to the qualified person responsible for pharmacovigilance:

   1. (a)

      a description of the responsibilities demonstrating that the qualified person responsible for pharmacovigilance has sufficient authority over the pharmacovigilance system in order to promote, maintain and improve compliance with pharmacovigilance tasks and responsibilities;

   2. (b)

      a summary curriculum vitae of the qualified person responsible for pharmacovigilance, including proof of registration with the Eudravigilance database;

   3. (c)

      contact details of the qualified person responsible for pharmacovigilance;

   4. (d)

      details of back-up arrangements to apply in the absence of the qualified person responsible for pharmacovigilance;

   5. (e)

      responsibilities of the contact person for pharmacovigilance issues where such a person has been nominated at national level in accordance with Article 104(4) of Directive 2001/83/EC, including contact details;

2. (2)

   a description of the organisational structure of the marketing authorisation holder, including the list of the site(s) where the following pharmacovigilance activities are undertaken: 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 the terms of a marketing authorisation;

3. (3)

   a description of the location of, functionality of and operational responsibility for computerised systems and databases used to receive, collate, record and report safety information and an assessment of their fitness for purpose;

4. (4)

   a description of data handling and recording and of the process used for each of the following pharmacovigilance activities:

   1. (a)

      the continuous monitoring of the risk-benefit balance of the medicinal product(s), the result of that monitoring and the decision-making process for taking appropriate measures;

   2. (b)

      operation of the risk management system(s) and of the monitoring of the outcome of risk minimisation measures;

   3. (c)

      collection, assessment and reporting of individual case safety reports;

   4. (d)

      drafting and submission of periodic safety update reports;

   5. (e)

      procedures for communicating safety concerns and safety variations to the summary of product characteristics and package leaflet to healthcare professionals and the general public;

5. (5)

   a description of the quality system for the performance of pharmacovigilance activities, including all of the following elements:

   1. (a)

      a description of the management of human resources referred to in Article 10 containing the following elements: a description of the organisational structure for the performance of pharmacovigilance activities with a reference to the location of qualification records of the personnel; a summary description of the training concept, including a reference to the location of training files; instructions on critical processes;

   2. (b)

      a description of the record management system referred to in Article 12, including the location of the documents used for pharmacovigilance activities;

   3. (c)

      a description of the system for monitoring the performance of the pharmacovigilance system and for the compliance with Article 11;

6. (6)

   where applicable, a description of the activities and/or services subcontracted by the marketing authorisation holder in accordance with Article 6(1).

The pharmacovigilance system master file shall have an Annex containing the following documents:

1. (1)

   a list of medicinal products covered by the pharmacovigilance system master file, including the name of the medicinal product, the international non-proprietary name (INN) of the active substance(s), and the Member State(s) in which the authorisation is valid;

2. (2)

   a list of written policies and procedures for the purpose of complying with Article 11(1);

3. (3)

   the list of subcontracts referred to in Article 6(2);

4. (4)

   a list of the tasks that have been delegated by the qualified person for pharmacovigilance;

5. (5)

   a list of all scheduled and completed audits;

6. (6)

   where applicable, a list of the performance indicators referred to in Article 9;

7. (7)

   where applicable, a list of other pharmacovigilance system master files held by the same marketing authorisation holder;

8. (8)

   a logbook containing the information referred to in Article 5(4).