This Regulation aims to establish uniform rules on the size of small immediate packaging units in order to reduce administrative burden and improve both the functioning of the internal market and the availability of veterinary medicinal products in the Union. It gives emphasis on all the essential information to be presented on the label in a readable manner. In accordance with Article 12 of Regulation (EU) 2019/6, the following types of immediate packaging shall be considered to be small immediate packaging units: (i) blisters or strips; (ii) ampoules and small single-dose containers other than ampoules; (iii) a container or any other 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. In case the veterinary medicinal product is classified as subject to veterinary prescription in accordance with Article 34 of Regulation (EU) 2019/6, the competent authorities of Member States, or where relevant, the Commission, may consider multilingual immediate packaging units not exceeding a nominal volume of 100 ml to qualify as small immediate packaging units.
2024-03-21