When first received, the information in suspected adverse reactions reports may be incomplete. These reports should be followed-up as necessary to obtain supplementary detailed information significant for the scientific evaluation of the cases. This is particularly relevant for monitored events of special interest, prospective reports of pregnancy (see VI.B.6.1. for guidance on the management of pregnancy reports), cases notifying the death of a patient, or cases reporting new risks or changes in the known risks. This is in addition to any effort to collect missing minimum criteria for reports validation (see VI.B.2. for ICSRs validation). Any attempt to obtain follow-up information should be documented.

The provision in ICSRs of information on the patient’s age is important in order to be able to identify safety issues occurring specifically in the paediatric or elderly population. Reasonable efforts should be made to follow-up on ICSRs where information on the patient’s age or age group is initially not reported by the primary source (see VI.B.6.2. for guidance on paediatric or elderly population).

Similarly, for suspected adverse reactions related to biological medicinal products, the definite identification of the concerned products with regard to their manufacturing is of particular importance. Therefore, all appropriate measures should be taken to clearly identify the names of the products and their batch numbers. With respect to this, it is recommended to specify in the case narrative if information on the batch number has been requested, when it is missing in the initially submitted ICSR. The business process map and a process description in VI.App.1.1. take into account the mandatory follow-up in the EU of information for the identification of suspected biological medicinal products. For cases related to vaccines, GVP Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases and GVP Product- or Population-Specific Considerations II: Biological medicinal products should also be followed as appropriate.

Follow-up methods should be tailored towards optimising the collection of missing information. This should be done in ways that encourage the primary source to submit new information relevant for the scientific evaluation of a particular safety concern. The use of targeted specific forms in the local language should avoid requesting the primary source to repeat information already provided in the initial report and/or to complete extensive questionnaires, which could discourage future spontaneous reporting. Therefore, consideration should be given to pre-populating some data fields in those followup report forms to make their completion by the primary source easy.

When information is received directly from a consumer suggesting that an adverse reaction may have occurred, and if the information is incomplete, attempts should be made to follow-up with the consumer to obtain consent to contact a nominated healthcare professional to obtain further information. When the case is subsequently confirmed totally or partially by a healthcare professional, the medical confirmation should be captured in the ICSR in line with ICH-E2B (see VI.A.1.4. for healthcare professionals’ definition, and VI.A.1.5. for ICSRs medical confirmation).

For some cases, it may not always be possible to perform follow-up activities taking into account that the reporter information may have been anonymised in accordance with local legal requirements or due to provisions that allow for anonymous reporting (see VI.C.6.2.2.10. for guidance on the processing of personal data in the EU), for example in case of medication error with harm and the reporter does not wish to disclose an identity. These cases should be considered valid for submission as ICSRs, providing that the notified organisation was able to confirm them directly with the primary sources and that the other minimum criteria for reports validation are satisfied (see VI.B.2. for ICSRs validation).

Further EU guidance on follow-up activities applicable to competent authorities in Member States and to marketing authorisation holders is provided respectively in VI.C.2.1. and VI.C.2.2. with business process maps and process descriptions included in VI.App.1.1. and VI.Ap.1.2.. Guidance on the electronic submission in the EU of follow-up reports is available in VI.C.6.2.2.7.