Overview of issuance of decisions/notifications for MRP variations

Sending of notifications/decisions on MRP variations where the Czech Republic is the Reference Member State (RMS) as well as the Concerned Member State (CMS)

Type IA, IB, II variations

Type IA, IB, II grouping

Type IB, II worksharing

Post-End-of-Procedure issuance of notification/decision

Rejection

 

Nothing to be issued

Acceptance

Non-text changes, the accepted changes do not change the Marketing Authorisation

Nothing to be issued

Non-text changes, the accepted changes change the Marketing Authorisation

Decision on Variation to Marketing Authorisation

Text changes, the accepted changes do not change the Marketing Authorisation

Notification of the wording of texts together with the texts

Text changes, the accepted changes change the Marketing Authorisation

Decision on Variation to Marketing Authorisation together with the texts

 

Marketing Authorisation has to be changed in case the variation to marketing authorisation impacts data contained in the Marketing Authorisation:

  • The name of the medicinal product is changed;
  • The classification for dispensing of the medicinal product is changed;
  • PSUR submission frequency is changed;
  • An exemption from stating the name of the medicinal product in Braille is being granted;
  • Obligations for the marketing authorisation holder are being established;
  • Conditions of the marketing authorisation are being established.

 

Where several text changes are handled at one time:

Common texts for several administrative procedures shall be sent together with a single decision/notification regarding the wording of the texts. In respect of other procedures regarding the text changes, a decision/notification (depending on the type of variation) on the wording of the texts shall be issued, referencing the decision/notification for which the texts are sent.

Marketing Authorisation Branch

25th February 2020