Co-distribution of veterinary medicinal products
Where a veterinary medicinal product is co-distributed according to the relevant marketing authorisation or registration, the co-distributor will place that product on the market under his own name, based on agreement with the marketing authorisation holder by civil law. The name or company name of the co-distributor should be indicated on the immediate packaging and - where available - on the outer packaging of the veterinary medicinal product.
Articles 10 and 11 of Regulation (EU) 2019/6 regulate which information is permitted on the immediate packaging and outer packaging of veterinary medicinal products. Deviating from this, Member States may, under the conditions laid down in Article 13 of Regulation (EU) 2019/6, authorise additional relevant information on the immediate packaging and the outer packaging. Accordingly, the indication of a co-distributor with name or company name is considered to be such an additional relevant information within the meaning of Article 13 of Regulation (EU) 2019/6 and may be authorised at the request of the applicant.
According to Article 14(2) of Regulation (EU) 2019/6, the package leaflet may contain additional information on distribution. Accordingly, a co-distributor should also be listed in the package leaflet of the veterinary medicinal product (with name or company name and address) in addition to the marketing authorisation holder.
Veterinary medicinal products that have already been authorised before 28 January 2022 (date of application of Regulation (EU) 2019/6) with a corresponding label or package leaflet also meet the requirements of the new veterinary medicinal products legislation in this respect. Variation of the authorisation conditions is therefore not necessary.
The addition or deletion of a co-distributor is classified as a variation requiring assessment (VRA – E.z. (R)) in accordance with Article 62 of Regulation (EU) 2019/6.
The holder of a marketing authorisation is also obliged to collect the necessary data on the sales volume for its veterinary medicinal products distributed by a co-distributor and enter it in the product database (see Article 58 (11) and (12) of Regulation (EU) 2019/6). Corresponding agreements for the transfer of the necessary data between the marketing authorisation holder and the co-distributor should be concluded.
Marketing authorisation statistics at a glance
Processing statistics for the marketing authorisation of veterinary medicinal products YYYY (German only)
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- European marketing authorisation procedures
- National authorisation
- Veterinary medicinal products for food-producing animals
- Assessment of applications for marketing authorisation
- Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Marketability and legal status of supply
- Variation of marketing authorisation, registration, exemption
- SPC harmonisation
- Parallel trade
- Registration
- Co-distribution of veterinary medicinal products
- Examination of registration documents