The Human Medicines Regulations 2012

[F1 Content of the pharmacovigilance system master file U.K.

2.   The pharmacovigilance system master file must, as a minimum, contain—

(a) the following information relating to the qualified person responsible for pharmacovigilance—

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

(ii) a summary curriculum vitae of the qualified person responsible for pharmacovigilance,

(iii) contact details of the qualified person for pharmacovigilance,

(iv) details of back-up arrangements to apply in the absence of the qualified person responsible for pharmacovigilance, and

(v) responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));

(b) a description of the organisational structure of the holder, including the list of each site where one or more of the following pharmacovigilance activities are undertaken—

(i) individual case safety report collection and evaluation,

(ii) safety database case entry,

(iii) periodic safety update report production,

(iv) signal detection and analysis,

(v) risk management plan management,

(vi) pre and post-authorisation study management, and

(vii) management of safety variations to the terms of a UK marketing authorisation;

(c) 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;

(d) a description of data handling and recording and of the process used for each of the following pharmacovigilance activities—

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

(ii) operation of each risk management system and of the monitoring of the outcome of risk minimisation measures,

(iii) collection, assessment and reporting of individual case safety reports,

(iv) drafting and submission of periodic safety update reports, and

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

(e) a description of the quality system for the performance of pharmacovigilance activities, including—

(i) a description of—

(aa) the organisational structure for the performance of pharmacovigilance activities,

(bb) a summary description of the training concept, including a reference to the location of training files and qualifications records, and

(cc) instructions on critical processes,

(ii) a description of the record management system referred to in paragraph 12, including the location of the documents used for pharmacovigilance activities,

(iii) a description of the system for monitoring the performance of the pharmacovigilance system; and

(f) where applicable, a description of the activities or services subcontracted by the holder.]

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)