The Human Medicines Regulations 2012

[F1 PART 6 U.K. Transmission of reports of suspected adverse reactions

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)

Individual case safety reports U.K.

19.   Individual case safety reports must be used for reporting to the licensing authority suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.

Content of the individual case safety report U.K.

20.— (1) Holders must—

(a) ensure that individual case safety reports are as complete as possible; and

(b) communicate the updates of those reports to the licensing authority in an accurate and reliable manner.

(2) In the case of expedited reporting, the individual case safety report must include at least an identifiable reporter, an identifiable patient, one suspected adverse reaction and any medicinal product concerned.

(3) Holders and the licensing authority must record the details necessary for obtaining follow-up information on individual case safety reports and such reports must be adequately documented.

(4) When reporting suspected adverse reactions, holders must provide all available information on each individual case, including—

(a) administrative information, namely—

(i) report type, date and a worldwide unique case identification number as well as unique sender identification and sender type,

(ii) the date on which the report was first received from the source and the date of receipt of the most recent information, using a precise date, and

(iii) other case identifiers and their sources, as well as references to additional available documents held by the sender of the individual case safety report, where applicable;

(b) literature reference in accordance with the ‘Vancouver style’ as developed by the International Committee of Medical Journal Editors for adverse reactions reported in the worldwide literature, including a comprehensive English summary of the article;

(c) study type, study name and the sponsor's study number or study registration number for reports from studies not covered by the Clinical Trials Regulations;

(d) information on any primary source, namely information identifying the reporter, including country of residence and professional qualifications;

(e) information identifying the patient (and parent in the case of a parent-child report), including age at the time of the onset of the first reaction, age group, gestation period when reaction or event was observed in the foetus, weight, height or gender, last menstrual date and, where relevant, gestation period at time of exposure;

(f) relevant medical history and concurrent conditions;

(g) the name of any medicinal product suspected to be related to the occurrence of the adverse reaction, including interacting medicinal products or, where the name is not known, any active substance and any other characteristics that allow for the identification of a medicinal product, including—

(i) the name of the holder, UK marketing authorisation number, pharmaceutical form and each (parent) route of administration,

(ii) any indication for use in the case, dose administered, start date and end date of administration,

(iii) actions taken with any medicinal product, and

(iv) effect of the dechallenge and rechallenge for suspect medicinal products;

(h) for a biological medicinal product, the batch number;

(i) concomitant medicinal products, identified in accordance with paragraph (g), which are not suspected to be related to the occurrence of the adverse reaction and past-medical drug therapy for the patient (and for the parent), where applicable;

(j) information on any suspected adverse reaction, including—

(i) start date and end date of any suspected adverse reaction or duration,

(ii) seriousness,

(iii) outcome of any suspected adverse reaction at the time of last observation,

(iv) time intervals between suspect medicinal product administration and start of any adverse reaction,

(v) the original reporter's words or short phrases used to describe any reaction, and

(vi) country of occurrence of the suspected adverse reaction;

(k) results of tests and procedures relevant to the investigation of the patient;

(l) in the event of death of the patient, date and reported cause of death, including autopsy-determined causes;

(m) a case narrative, where possible, providing all relevant information for individual cases with the exception of non-serious adverse reactions; and

(n) reasons for nullifying or amending an individual case safety report.

(5) For the purposes of—

(a) sub-paragraph (4)(b), upon request of the licensing authority, the holder that transmitted the initial report must provide a copy of the relevant article taking into account copyright restrictions, and a full translation of that article into English;

(b) sub-paragraph (4)(h), a follow-up procedure must be in place to obtain the batch number where it is not indicated in the initial report;

(c) sub-paragraph (4)(m), the information must be presented in a logical time sequence, in the chronology of the patient's experience including clinical course, therapeutic measures, outcome and follow-up information obtained: any relevant autopsy or post-mortem findings must also be summarised in the narrative.

(6) Suspected adverse reactions must be reported in English.

Format of electronic transmission of suspected adverse reactions U.K.

21.   Holders must use the formats and terminology specified in the list published under paragraph 18 for the electronic transmission of suspected adverse reactions, if the licensing authority has published a list under that paragraph.]