Article 28: Content of the individual case safety report

(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 (9) 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 (10);

(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.