Extension of pilot period for MAH requirements
Pharmacovigilance
On 22 November 2017, EMA launched the new EudraVigilance system. All marketing authorisation holders (MAHs) were required to monitor EudraVigilance data with a start date of 22 February 2018. The MAHs were required to inform the Agency and national competent authorities of validated signals based on this activity.
After input from the pharmaceutical industry during the review of the legislation, a transition period was implemented so that the requirement only applied to a limited number of active substances.
These are mostly recently approved substances and are stated in the ‘List of medicinal products under additional monitoring’.
Download the list (xls) of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders.
Transition period is now until end of 2023
The transition period for the requirement was planned to last one year. In 2019 the period was first extended.
In August 2022 EMA and the European Commission agreed to further extend the pilot until the end of 2023.
MAHs with active substances included in the list should continue to monitor them in EudraVigilance for the duration of the pilot period.
All other MAHs also have access to EudraVigilance data and can integrate the data into their own signal management processes. However, during the pilot period they will have no obligation to continuously monitor EudraVigilance and inform the regulatory authorities of validated signals from EudraVigilance.
A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. EMA, together with the regulatory authorities in the Member States and MAHs are responsible for detecting and managing safety signals.
Guidance on regulatory requirements and on the monitoring and reporting processes for signals is available in good pharmacovigilance practices (GVP) Module IX on signal management.
If you need more information or assistance on pharmacovigilance, please contact:
Susanne Felumb, CEO, MSc. Pharm or Ea Dige, MD, Pharmacovigilance Manager, QPPV