CHAPTER V

Transmission of reports of suspected adverse reactions

Individual case safety reports
Article 27
Individual case safety reports shall be used for reporting to the Eudravigilance database 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
Article 28
1
Member States and marketing authorisation holders shall ensure that individual case safety reports are as complete as possible and shall communicate the updates of those reports to the Eudravigilance database in an accurate and reliable manner.
In the case of expedited reporting, the individual case safety report shall include at least an identifiable reporter, an identifiable patient, one suspected adverse reaction and the medicinal product(s) concerned.
2
Member States and marketing authorisation holders shall record the details necessary for obtaining follow-up information on individual case safety reports. The follow-up of reports shall be adequately documented.
3
When reporting suspected adverse reactions, Member States and marketing authorisation holders shall provide all available information on each individual case, including the following:
a
administrative information: report type, date and a worldwide unique case identification number as well as unique sender identification and sender type; 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; 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 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
d
information on the primary source(s): information identifying the reporter, including Member State 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/event was observed in the foetus, weight, height or gender, last menstrual date and/or gestation period at time of exposure;
f
relevant medical history and concurrent conditions;
g
the name, as defined in Article 1(20) of Directive 2001/83/EC, of the medicinal product(s) suspected to be related to the occurrence of the adverse reaction, including interacting medicinal products or, where the name is not known, the active substance(s) and any other characteristics that allow for the identification of the medicinal product(s), including the name of the marketing authorisation holder, marketing authorisation number, country of marketing authorisation, pharmaceutical form and (parent) route(s) of administration, indication(s) for use in the case, dose administered, start date and end date of administration, actions taken with the medicinal product(s), effect of the dechallenge and rechallenge for suspect medicinal products;
h
for biological medicinal product(s), the batch number(s);
i
concomitant medicinal products, identified in accordance with point (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 the suspected adverse reaction(s): start date and end date of the suspected adverse reaction(s) or duration, seriousness, outcome of the suspected adverse reaction(s) at the time of last observation, time intervals between suspect medicinal product administration and start of adverse reaction, the original reporter’s words or short phrases used to describe the reaction(s) and Member State or third-country of occurrence of the suspected adverse reaction;
k
results of tests and procedures relevant to the investigation of the patient;
l
date and reported cause of death, including autopsy-determined causes, in the event of death of the patient;
m
a case narrative, where possible, providing all relevant information for individual cases with the exception of non-serious adverse reactions;
n
reasons for nullifying or amending an individual case safety report.
For the purposes of point (b), upon request of the Agency, the marketing authorisation holder that transmitted the initial report shall provide a copy of the relevant article taking into account copyright restrictions, and a full translation of that article into English.
For the purposes of point (h), a follow-up procedure shall be in place to obtain the batch number where it is not indicated in the initial report.
For the purposes of point (m), the information shall 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 shall also be summarised in the narrative.
4
Where suspected adverse reactions are reported in narrative and textual descriptions in an official language of the Union other than English, the original verbatim text and a summary thereof in English shall be provided by the marketing authorisation holder.
Member States may report case narratives in their official language(s). For those reports, case translations shall be provided where requested by the Agency or other Member States for the evaluation of potential signals.
English shall be used for the reporting of suspected adverse reactions originating outside the Union.

Format of electronic transmission of suspected adverse reactions
Article 29
Member States and marketing authorisation holders shall use the formats provided for in Article 26 and the terminology provided for in Article 25 for the electronic transmission of suspected adverse reactions.
International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 1997; 336:309-15.
OJ L 121, 1.5.2001, p. 34.
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)