According to § 29 TAMG, veterinary medicinal products and veterinary technical products requiring authorisation according to § 22 para. 1 TAMG, as well as test sera and test antigens, may only be traded within Germany with a wholesale licence.
In addition, § 40 para. 2 TAMG stipulates that veterinary medicinal products and veterinary technical products which are exempt from the obligation to obtain a marketing authorisation according to § 4 TAMG are always classified as freely marketable. However, according to § 45 para. 8 TAMG, only holders of a wholesale licence may sell over-the-counter veterinary medicinal products as defined in § 40 para. 1 TAMG to retailers in Germany, provided they have the required expertise. The required expertise is possessed by anyone who demonstrates knowledge and skills in the proper filling, packaging, labelling, storage and provision of over-the-counter veterinary medicinal products and veterinary technical products as well as knowledge of the regulations applicable to these veterinary medicinal products and veterinary technical products.
Wholesale distribution is defined in Article 4(36) of Regulation (EU) 2019/6 as follows:
"...means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products whether for profit or not, apart from retail supply of veterinary medicinal products to the public"
Consequently, the definition does not distinguish between authorised veterinary medicinal products and pet veterinary medicinal products that are exempt from authorisation. In addition, with regard to § 45 para. 8 TAMG, it is to be assumed that a supply to the retail trade always requires a wholesale distribution licence.
For all foreign traders, it also applies that according to § 25 Para. 1 TAMG, only veterinary medicinal products or veterinary technical products that are subject to the obligation to obtain a marketing authorisation according to § 22 TAMG or the exemption according to § 4 TAMG (from other EU countries) may be brought to Germany if they are authorised for making available on the market in Germany or if they are exempted and
- in the case of transfer from a Member State of the European Union or another State party to the Agreement on the European Economic Area, the recipient is a wholesaler or veterinary surgeon or operates a pharmacy, or
As a result, with regard to the German market, a wholesale distribution licence is required both for wholesale trade in veterinary medicinal products subject to authorisation and for wholesale trade in veterinary medicinal products that are exempt from authorisation. This applies in particular if a company in another EU country wants to supply veterinary medicinal products to partner companies in Germany.
We provide you with a tailor-made quality management system, train your employees and help you to implement it in practice. In doing so, we also accompany your application procedure from the beginning, the selection of possible service providers, the preparation of the inspection up to their accompaniment on site.
You are already in possession of a wholesale licence for veterinary medicinal products and need help?
We offer you:
- A comprehensive process analysis (analysis of your quality-relevant activities)
- GAP analysis of your QM system and the complete quality-relevant documentation
- Ensuring regulatory conformity and timeliness ("inspection readiness")
- Creation of an individual action plan
- Monitoring the implementation of the necessary measures