Commission Implementing Regulation (EU) 2024/878 of 21 March 2024 adopting uniform rules on the size of small immediate packaging units of veterinary medicinal products as referred to in Article 12 of Regulation (EU) 2019/6 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/878 of 21 March 2024 adopting uniform rules on the size of small immediate packaging units of veterinary medicinal products as referred to in Article 12 of Regulation (EU) 2019/6 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. The following types of immediate packaging shall be considered to be small immediate packaging units within the meaning of Article 12 of Regulation (EU) 2019/6:
(a)
blisters or strips;
(b)
ampoules and small single-dose containers other than ampoules;
(c)
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.
2. By way of derogation from paragraph 1, point (c), 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 where the following conditions are fulfilled:
(a)
the immediate packaging unit is too small or has a shape or configuration that makes it impossible to accommodate the information referred to in Article 10(1) of Regulation (EU) 2019/6 in a readable manner, and
(b)
the veterinary medicinal product is classified as subject to veterinary prescription in accordance with Article 34 of Regulation (EU) 2019/6.
Veterinary medicinal products authorised before 11 May 2024, or which are subject to an ongoing application for a marketing authorisation on 11 May 2024, once authorised, may be placed on the market until 11 April 2031, even if the information contained on their labelling as regards immediate packaging units is not in compliance with this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 11 May 2024.
