Wholesalers
Wholesalers of veterinary medicines
Wholesalers play a vital role in the veterinary medicine supply chain. They ensure the safe, continuous and compliant distribution of products to vets and pharmacies.
This page provides further information on their responsibilities, regulatory obligations and contributions to the quality and availability of veterinary treatments in Luxembourg.
European legal framework
The wholesale distribution of veterinary medicines is governed by Regulation (EU) 2019/6 on veterinary medicinal products, which came into force in January 2022. This text harmonises the rules concerning the manufacture, marketing authorisation, distribution and pharmacovigilance of animal health products across all Member States.
In Regulation (EU) 2019/6 on veterinary medicinal products, the chapter dealing with wholesale distribution is Chapter VII.
More specifically:
- Article 99 states that the wholesale distribution of veterinary medicinal products requires a wholesale distribution authorisation.
- Article 100 covers the obligations of wholesale distributors.
- Article 101 sets out the obligations relating to wholesale distribution and to storage, delivery and transport operations
In addition, Implementing Regulation (EU) 2021/1248 of 29 July 2021 lays down detailed requirements to ensure the quality, traceability and safety of medicinal products throughout the supply chain. In particular, this Regulation imposes strict conditions for storage, transport and the management of returns, as well as the establishment of a quality assurance system tailored to the specificities of the veterinary sector.
This text sets out in concrete terms the requirements of Chapter VII of Regulation (EU) 2019/6.
It lays down the good practice rules applicable to the wholesale distribution of veterinary medicinal products, covering in particular:
- Quality system (Article 4)
→ Requirement for a documented system, a quality manager and internal procedures. - Staff (Article 5)
→ Competence, training and hygiene of staff handling medicinal products. - Premises and equipment (Article 6)
→ Storage conditions, cleaning, safety and prevention of contamination. - Documentation (Article 7)
→ Records, SOPs, version control and document retention. - Delivery and receipt (Articles 8–9)
→ Control of suppliers and customers, verification of authorisations. - Storage and transport (Articles 10–11)
→ Compliance with temperature, humidity and safety conditions throughout the supply chain. - Returns, recalls and falsifications (Articles 12–13)
→ Procedures for managing returns, market withdrawals and suspected falsified products. - Outsourcing (Article 14)
→ Written contracts and supervision of external service providers. - Self-inspections (Article 15)
→ Regular internal audits of the quality system and corrective actions.
Inspections and controls
In Luxembourg, the Pharmacy and Medicines Division is responsible for inspecting establishments authorised to wholesale veterinary medicinal products.
These inspections aim to ensure compliance with Regulation (EU) 2019/6 on veterinary medicinal products, Delegated Regulation (EU) 2021/1248 of 29 July 2021 and Good Distribution Practices. (GPD)
The list of inspection requirements is available below, with a view to promoting transparency, quality and compliance in the distribution of veterinary medicinal products within Luxembourg.
The distribution authorisation is valid for an indefinite period: it remains valid as long as the establishment meets the regulatory requirements and complies with the periodic inspections carried out by the competent authority.
In practice, inspections take place at a frequency determined by the nature and risk level of the activity. However, any major change (address, person in charge, facilities, type of activity, etc.) requires an application to update the authorisation.
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