F1CHAPTER IIMinimum requirements for the quality systems for the performance of pharmacovigilance activities

Section 2Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders

Article 10Management of human resources

1.

The marketing authorisation holder shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.

For the purposes of the first subparagraph, the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities. Where the qualified person has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications8, the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person. This assistance shall be duly documented.

2.

The duties of the managerial and supervisory staff, including the qualified person responsible for pharmacovigilance, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisational chart. The marketing authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorisation holder.

3.

All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training in relation to their role and responsibilities. The marketing authorisation holder shall keep training plans and records for documenting, maintaining and developing the competences of personnel and make them available for audit or inspection.

4.

The marketing authorisation holder shall provide appropriate instructions on the processes to be used in case of urgency, including business continuity.