QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC
4.1. [NEW] Is there any impact on reporting into EudraVigilance of Individual Case Safety Reports (ICSRs)?
According to Article 107 of Directive 2001/83/EC, MAHs shall submit electronically to the Eudravigilance database all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH gained knowledge of the event. All non-serious suspected adverse reactions that occur in the Union shall be submitted within 90 days.
This includes adverse reactions that result from use outside the terms of the marketing authorisation (off-label use).
During the current pandemic the reporting of adverse events related to the widespread use of medicinal products for the treatment or prevention of the pathogen causing the pandemic may increase. At the same time, there is a risk that during a pandemic workforces in industry may be reduced due to high employee absenteeism.
These exceptional circumstances may force companies to activate business continuity plans and prioritise activities.
Therefore, in case MAHs are for justified reasons relating to the pandemic unable to continue standard reporting operations, they should temporarily – until the pandemic is resolved – prioritise the reporting obligations as follows:
- Submission of serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
- Submission of other serious ICSRs;
- Submission of non-serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
- Submission of other non-serious ICSRs.
While in the present exceptional circumstances, some MAHs may have understandable difficulties complying with the relevant deadlines, it is essential that MAHs report all serious ICSRs within the 15 days set out in Directive 2001/83/EC. Where MAHs make use of prioritisation, they shall put a note in the pharmacovigilance system master file recording such practice.
For reports originating from compassionate use or named patient use, marketing authorisation holders should continue to follow the guidance in GVP Module VI Section VI.C.1.2.2.