The Human Medicines Regulations 2012

[F1 PART 4 U.K. Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority

Textual Amendments

F1 Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)

Management of human resources U.K.

14.— (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.

Compliance management U.K.

15.   The licensing authority must establish specific procedures and processes in order to achieve the following objectives—

(a) ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted;

(b) ensuring the assessment of pharmacovigilance data and its processing within the timelines provided for in Part 11 of these Regulations;

(c) ensuring independence in the performance of pharmacovigilance activities;

(d) ensuring effective communication among regulatory bodies in countries other than the United Kingdom who have the same or similar functions as the licensing authority, as well as with patients, healthcare professionals, marketing authorisation holders and the general public; and

(e) conducting inspections, including pre-authorisation inspections.

Record management and data retention U.K.

16.— (1) The licensing authority must—

(a) record all pharmacovigilance information, and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information; and

(b) put in place a record management system for all documents used for pharmacovigilance activities that ensures—

(i) the retrievability of those documents, and

(ii) the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.

(2) The licensing authority must arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years, such period beginning with the day after the system has been formally terminated.

(3) Pharmacovigilance data and documents relating to individual authorised medicinal products must be retained by the licensing authority for as long as the product is authorised and for at least 10 years, such period beginning with the day after the UKMA(GB) has expired.

Audit U.K.

17.— (1) Risk-based audits of the quality system must be performed by the licensing authority at regular intervals to ensure that the quality system complies with the requirements set out in paragraphs 8, 14, 15 and 16, and to ensure its effectiveness.

(2) Following a risk-based audit—

(a) any corrective action, including a follow-up audit of deficiencies, must be taken where necessary;

(b) a report on the results of the audit must be drawn up for each audit and follow-up audit;

(c) the audit report must be sent to the management responsible for the matters audited; and

(d) the dates and results of audits and follow-up audits must be documented.]