A new version (3) of the document ‘National FAQ on variations’ is available.
This update concerns among others the following topics:
- The procedure number to use: an additional clarification was added.
- Some changes in colour, lay-out and rearrangements to mock-up should be submitted through a notification.
- Questions and answers concerning the submission of a transfer MAH/distributor were added.
- The specific information concerning the national procedure is deleted as this procedure is included in the Variation Regulation.
- Implementation/ approval date: text was replaced by a reference to the document ‘New definition of the approval date in SmPC and leaflet’.
- Determination of the fee for worksharing: question and answer were added.