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. A cover letter and new proposed package leaflets and/or mock-ups, and the previously approved documents in which the changes are clearly marked shall be annexed to the notification need to be submitted. The changes may be implemented after 90 days, if Fimea has not commented on the suggested change.

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.

90-day notifications must be submitted to Fimea same way as all other marketing authorisation applications. Applications that arrive only via email, will not be handled.

Labelling changes that require notification include proposals for a new layout, changes in font size and appearance, changes in images and colours, 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. If the marketing authorization holder's logo changes, it must be notified to Fimea if its size or position on the packaging changes, or if the logo change leads to other changes in the packaging's layout.

The files must be created according to the instructions. It is not necessary to submit electronic package leaflets for registered homeopathic and anthroposophic preparation.

For veterinary medicines The EU Veterinary Medicines Regulation (2019/6) is applied.