Article 13 of Regulation (EU) 2019/6 states that, by derogation from Articles 10 (1), 11 (1) and 12 (1), a Member State may allow an applicant to include on the immediate or outer packaging of a veterinary medicinal product additional useful information which is compatible with the summary of the product characteristics and which is not an advertisement for a veterinary medicinal product.

You can submit this application as follows:

• during an marketing authorisation or any text-relevant variation. It is sufficient to include a corresponding note in an appropriate document, for example in the cover letter, in the eAF, as a note in the tracked version of the label, etc.

• as a stand-alone variation: VRA G.I.15.z) Changes to the labeling or the package leaflet which are not connected with the summary of product characteristics - Other changes under this code level, e.g. variations outlined in sections 6 and 7 

For examples of acceptable additional information, see Guidance on national-specific labeling/package leaflet information, which can be found at the following link: Heads of Medicines Agencies: General Information on Applications (hma.eu).