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EMA Guidance: EudraVigilance Registration Documents

The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents" which provides detailed guidelines on the registration process with EMA for Marketing Authorisation Holders (MAHs), Commercial and Non-commercial Sponsors and National Competent Authorities (NCAs), including the assignment of the role of EU Qualified Person for Pharmacovigilance (EU QPPV)/Responsible Person (RP).

EudraVigilance is a system developed by the EMA to collect and evaluate reports of suspected adverse reactions to medicines that have been authorized or studied in clinical trials in the European Economic Area (EEA). It helps in monitoring the safety of medicines and protecting public health.

Pharmaceutical companies, national competent authorities (NCAs), and sponsors of clinical trials need to register with EudraVigilance to fulfill their pharmacovigilance obligations.

The major topics in this guidelines are

  • Pre-requisites

  • Registration of the headquarters for Marketing Authorisation Holders (MAHs)

  • Registration of the headquarters for Commercial and Non-commercial Sponsors

  • Registration of the headquarters of National Competent Authorities

Benefits of EudraVigilance Registration

  • Enhanced Safety Monitoring: Streamlined reporting and analysis of adverse drug reactions.

  • Regulatory Compliance: Ensures that companies meet their legal obligations for pharmacovigilance.

  • Improved Public Health: Facilitates the timely detection of safety signals, leading to quicker regulatory action when necessary.

Following the EMA guidance on EudraVigilance registration ensures that pharmaceutical companies and clinical trial sponsors comply with European regulations for drug safety monitoring. Proper registration helps maintain the integrity of pharmacovigilance activities, ultimately protecting public health.

For detailed information and to access the necessary forms, you can read the full guidance document here.

Also check out this updated guidance on "New Organisation First User EU QPPV/RP or Change of EU QPPV/RP" that describes the actions required by Marketing Authorisation Holders (MAHs), Commercial and Non-commercial Sponsors, and National Competent Authorities (NCAs) for registering or changing EU Qualified Person for Pharmacovigilance (EU QPPV)/Responsible Person (RP).


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