Spontaneous adverse reaction reports

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 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

Updated 19 April 2012