CHAPTER II

Minimum requirements for the quality systems for the performance of pharmacovigilance activities
Section 3

Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency

Management of human resources
Article 14
1
The national competent authorities and the Agency shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.
The organisational structures and the distribution of tasks and responsibilities shall be clear and, to the extent necessary, accessible. Contact points shall be established.
2
All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training. The national competent authorities and the Agency shall keep training plans and records for documenting, maintaining and developing the competences of personnel and shall make them available for audit.
3
Appropriate instructions on the processes to be used in case of urgency, including business continuity, shall be provided by the national competent authorities and by the Agency to their personnel.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)