Good Distribution Practice for wholesale in medicines
This Regulation (EU) 2021/1248 lays down the measures on good distribution practice for veterinary medicinal products published in the Official Journal of the European Commission on 29 July 2021.. This Regulation applies to holders of a manufacturing authorisation performing wholesale distribution of the veterinary medicinal products covered by that manufacturing authorisation, and to holders of a wholesale distribution authorisation, including those established or operating under specific customs regimes, such as free zones or customs warehouses.
Certain dispositions in the royal decree of the 1st of September 2024 on veterinary medicines are also applicable to the wholesale of medicines.
(Royal decree available in Dutch & French)
(1) Article 12ter of the law of 25th of march 1964 on medicinal products
(2) Article 12bis of the law of 25th of march 1964 on medicinal products