Changes to labelling
For national preparations, changes to package labelling or package leaflet can be made via so-called 90-day notifications, which are not subject to a handling fee and do not require an application form. The changes may be implemented after 90 days, if Fimea has not commented on the suggested change. Similar changes to veterinary medicines must be made by submitting an C.II.6 variation application.
Changes to the packaging labels or package leaflet of preparations that have received a marketing authorisation via the mutual recognition procedure are national 90-day notifications, or, if the package leaflet and labelling have been harmonised in the mutual recognition procedure or decentralised procedure, the changes are P changes applied for via the mutual recognition procedure, article 61(3). These changes are processed as described in the CMDh guidelines.
Labelling changes that require notification include proposals for a new layout, changes in font size and appearance, changes in images, colours and logos, changes to the text, changes in text positioning, and changes regarding local representative. Fimea does not require notification of, for example, changes to barcodes or minor changes to the size of the packaging/label, if these do not affect text size or positioning.
An electronic version of the package leaflets and package labels must be submitted along with the variation application. The files must be created according to the instructions. It is not necessary to submit electronic package leaflets for registered homeopathic and anthroposophic preparation.