BAKGRUNN (fra kommisjonsforordningen)

(1) Article 12(1) of Regulation (EU) 2019/6 sets out the information to be contained on the labelling of small immediate packaging units of veterinary medicinal products. That information is limited in order to ensure that all the essential information can be presented on the label in a readable manner. 

(2) In accordance with Article 17(3) of Regulation (EU) 2019/6, uniform rules on the size of small immediate packaging units are to be adopted. Such uniform rules should contribute to reducing the administrative burden for marketing authorisation holders, improving the functioning of the internal market and increasing the availability of veterinary medicinal products in the Union. 

(3) In accordance with the existing guidance of the Working Group on Quality Review of Documents of the European Medicines Agency, any form of packaging that is in direct contact with the veterinary medicinal product and has a nominal volume of up to and including 50 ml, should be considered as a small immediate packaging unit. 

(4) Pursuant to Article 7(2) of Regulation (EU) 2019/6, veterinary medicinal products may be labelled in several languages. Some packaging units with a nominal volume exceeding 50 ml might still be too small or might have a shape or configuration that makes it impossible to accommodate in readable form all the labelling information as set out in Article 10(1) of Regulation (EU) 2019/6 in several national languages. For those cases, a derogation to the 50ml threshold should be provided for. To ensure that the user is correctly informed on the properties of the product, this derogation should only apply to veterinary medicinal products subject to veterinary prescription. 

(5) 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 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 information contained on their labelling as regards immediate packaging units does not comply with this Regulation. 

(6) 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. 

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