Transfer of data on suspected adverse reactions to WHO

As of 2017, EMA operates a regular transfer of data on suspected adverse drug reactions occurring in the European Union (EU) to the World Health Organization (WHO)'s Uppsala Monitoring Centre.

The data comes from the EudraVigilance system and contributes to WHO's global database of individual case safety reports, VigiBase. 

The WHO's Uppsala Monitoring Centre manages VigiBase on behalf of the WHO Programme on International Drug Monitoring.

EU Member States, EMA and other countries and stakeholders consult VigiBase when investigating risks with medicines.

The framework allowing EMA to make all suspected adverse reaction reports occurring in the EU promptly available to WHO is a legal requirement under Article 28c of Regulation (EC ) No 726/2004.

For more information, see:

• World Health Organization (WHO)
• EudraVigilance
• WHO's Uppsala Monitoring Centre
• VigiBase
• WHO Programme on International Drug Monitoring

Revisions of modalities and conditions for data transfer

EMA and WHO-UMC updated the modalities and conditions for data transfer in 2020, in line with EU legislation on personal data protection and the EudraVigilance access policy.

These modalities and conditions remain valid as per their completed reviews by EMA and WHO-UMC initiated in 2022 and 2024.

They also remained unchanged following the 2025 revision 5 of the EudraVigilance access policy.

For more information, see:

• Access to EudraVigilance data

Exchange of letters on conditions for data transfer

Letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC

Reference Number: EMA/308793/2020

Response from UMC to letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC

Response from UMC to letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC

Find below the previous exchange letters on conditions for data transfer:

European Medicines Agency letter of arrangement with the World Health Organization (WHO) and the Uppsala Monitoring Centre (UMC) for making available EU adverse reaction reports

World Health Organization (WHO) reply to letter of arrangement between the European Medicines Agency and the WHO

Uppsala Monitoring Centre (UMC) reply to letter of arrangement between the European Medicines Agency and the UMC