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Spontaneous adverse reaction reports

Updated 19 April 2012

Marketing authorisations holders - Transition period

Marketing Authorisation Procedure Origin Adverse reaction type Destination Time frame

Centralised

 

MRP, decentralised or subject to referral

 

National

EU All serious  Member state where adverse
reaction occurred 
15 days
EU Non-serious The Danish Health and Medicines Authority if the adverse reaction
occurred in Denmark (during the transition period)
90 days
Non-EU All serious EudraVigilance database 15 days

Marketing authorisation holders - Final arrangement

Marketing Authorisation Procedure Origin Adverse reaction type Destination Time frame

Centralised

 

MRP, decentralised or subject to referral 

 

National

EU All serious EudraVigilance database 15 days 
EU  Non-serious  EudraVigilance database 90 days 
EU All serious  EudraVigilance database 15 days