BAKGRUNN (fra kommisjonsforordningen)

(1) Articles 10 and 11 of Regulation (EU) 2019/6 set out the information to be contained on the labelling of the immediate packaging or on the outer packaging of veterinary medicinal products. Article 10(2) and Article 11(3) of that Regulation require this information to be easily legible and clearly comprehensible or to appear in abbreviations or pictograms common throughout the Union. In accordance with Article 17(2) of that Regulation, a list of abbreviations and pictograms common throughout the Union is to be adopted. 

(2) The packaging of veterinary medicinal products is often small and therefore the label space is limited. The use of abbreviations and pictograms contributes to having all essential information contained on the label in a clear and readable format. The use of common abbreviations and pictograms should reduce the text on the labelling of veterinary medicinal products and facilitate the use of multilingual packaging. 

(3) Uniform rules on abbreviations and pictograms common throughout the Union for use on the labelling of the immediate and outer packaging of veterinary medicinal products should reduce administrative burden and improve both the functioning of the internal market and the availability of veterinary medicinal products in the Union. 

(4) In order to ensure a common understanding of abbreviations, the format and font used should be harmonised throughout the Union. 

(5) Simple and clear pictograms should make labels easier to understand. In order to avoid any potential misunderstanding, the meaning of each pictogram used on the labelling of a veterinary medicinal product should be explained in full text in the package leaflet accompanying the veterinary medicinal product concerned. 

(6) The proliferation of multiple pictograms for the same information should be avoided, in order not to create confusion for animal owners, animal keepers, veterinarians and retailers. Therefore, no other pictograms than those included in the Annexes to this Regulation should be used to replace the corresponding text as set out in the Annexes. Moreover, the colour in which pictograms are presented on the labelling should be harmonised. 

(7) Pictograms should be clearly distinguishable and readable for animal owners, animal keepers, veterinarians and retailers. Therefore, common rules on how pictograms are to be displayed on the labelling of a veterinary medicinal product should be set. 

(8) Veterinary medicinal products authorised before the date of application of this Regulation or which are subject to an ongoing application for a marketing authorisation on the date of application of this Regulation might contain abbreviations or pictograms that do not comply with the requirements of this Regulation. Therefore, to ensure the continued availability of those products it is necessary to provide for a transitional period during which they should be allowed to be placed on the market even if the pictograms and abbreviations used in their labelling do not comply with this Regulation. 

(9) Applicants intending to submit an application either for marketing authorisation or for a variation would need sufficient time to adapt their applications to make them compliant with the provisions set in this Regulation. Therefore, this Regulation should apply 30 days after the date of entry into force. 

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,