14/15 June 2021
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.
During the current pandemic the reporting of adverse events may increase. However, the agencies note that "there is a risk that during a pandemic workforces in industry may be reduced due to high employee absenteeism".
These circumstances may force companies to activate business continuity plans and prioritize activities. In case MAHs (marketing authorization holders) are for justified reasons (relating to the pandemic) unable to continue standard reporting operations, they should temporarily prioritize the reporting obligations as follows:
It is essential that MAHs report all serious ICSRs within the 15 days. Where MAHs make use of prioritization, they shall put a note in the pharmacovigilance system master file (PSMF). For reports originating from compassionate use or named patient use, MAHs should continue to follow the guidance in GVP (Good Pharmacovigilance Practice) Module VI.
The agencies note that it is necessary to facilitate the movement of medicinal products within the EU. During the COVID-19 pandemic, Member States may therefore accept that the labeling of products marketed in their territory may not be translated into the relevant official language.
It may moreover be accepted that national specific information does not appear in the packaging / labeling, or that the presentation differs from the presentations authorized in the Member State where the product is marketed.
However, "MAHs are required to notify the relevant national competent authorities in advance and should also provide a link to a website where the product information in the relevant official language may be obtained".
For further information please see the complete Q&A document on REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC.