# The Human Medicines Regulations 2012, Paragraph 14: Management of human resources


(1) The licensing authority must 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 must be clear and, to the extent necessary, accessible.
(2) Named contact points in the licensing authority for pharmacovigilance activities must be established.
(3) The licensing authority must ensure that—
(a) all of its personnel involved in the performance of pharmacovigilance activities receive initial and continued training;
(b) it keeps training plans and records for documenting, maintaining and developing the competences of personnel; and
(c) such plans and records are available for audit.
(4) The licensing authority must ensure that it provides to its personnel performing pharmacovigilance activities appropriate instructions on the processes to be used in case of urgency, including business continuity.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/14 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.