Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

Article 99Wholesale distribution authorisations

1.The wholesale distribution of veterinary medicinal products shall be subject to the holding of a wholesale distribution authorisation.

2.The holders of a wholesale distribution authorisation shall be established in the Union.

3.Wholesale distribution authorisations shall be valid throughout the Union.

4.Member States may decide that supplies of small quantities of veterinary medicinal products from one retailer to another in the same Member State shall not be subject to the requirement of holding a wholesale distribution authorisation.

5.By derogation from paragraph 1, a holder of a manufacturing authorisation shall not be required to hold a wholesale distribution authorisation for the veterinary medicinal products covered by the manufacturing authorisation.

6.The Commission shall, by means of implementing acts, adopt measures on good distribution practice for veterinary medicinal products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).