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)
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Type IA, IB, II variations Type IA, IB, II grouping Type IB, II worksharing |
Post-End-of-Procedure issuance of notification/decision |
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Rejection |
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Nothing to be issued |
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Acceptance |
Non-text changes, the accepted changes do not change the Marketing Authorisation |
Nothing to be issued |
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Non-text changes, the accepted changes change the Marketing Authorisation |
Decision on Variation to Marketing Authorisation |
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Text changes, the accepted changes do not change the Marketing Authorisation |
Notification of the wording of texts together with the texts |
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Text changes, the accepted changes change the Marketing Authorisation |
Decision on Variation to Marketing Authorisation together with the texts |
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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