Data overview for MRP marketing authorisations variations

MRP Variations to Marketing Authorisation

	Type IA	Type IA_IN	Type IB	Type II
Procedure duration	30 days	30 days	30 days	30/60/90 days
Validation phase	5 days	7 days	7 days	14 days
Submission of Czech texts by MAH	Together with the application	Together with the application	Together with the application	Within 5 days after RMS completion
Revision date	Date of implementation or RMS approval	Date of implementation or RMS approval	Date of RMS approval	Date of RMS approval
Implementation deadline for SÚKL	6 months	6 months	6 months	2 months
Implementation deadline for MAH	Within 12 months before submission or within 6 months after approval	Within 14 days before submission or within 3 months after approval	Within 6 months after approval	Within 6 months after approval; immediately if safety-related