A veterinary medicine can be manufactured under impeccable conditions and still reach the animal in an unusable state. Regulation (EU) 2019/6 places distribution under its own authorisation and good distribution practice requirements, and for many animal health companies the distribution chain is the least examined part of the operation. It is also the part most exposed to temperature excursions, diversion and falsified product.
Authorisation to distribute
Wholesale distribution of veterinary medicinal products requires authorisation from the competent authority of the Member State concerned, and distributors must comply with good distribution practice. Retail is dealt with separately under Article 103, with its own record-keeping duties, and retail at a distance under Article 104. Marketing authorisation holders supplying through third parties should be able to name every authorised entity their product passes through, and to produce the evidence of those authorisations without a search.
The obligations that matter most
- Supplier and customer qualification. Product should only be obtained from and supplied to entities authorised to hold it. Verifying that is a documented control, not a commercial assumption.
- Temperature control. Storage and transport conditions must match the approved product information across the whole journey, including the parts subcontracted to a logistics provider.
- Traceability. Records sufficient to reconstruct the movement of a batch, in both directions, quickly enough to support a recall.
- Recall capability. A recall procedure that has been tested rather than merely written, with contact data that is current.
- Returns, falsified product and diversion. Defined handling for returned stock and a route for reporting suspect product to the competent authority.
The veterinary specifics
Two features distinguish veterinary distribution. The customer base is more varied than in human medicine, extending from pharmacies and veterinary practices to agricultural merchants and feed businesses, each with different authorisation positions. And the products include items that carry heightened control expectations, notably antimicrobials, where distribution data increasingly feeds the sales and use reporting framework under Article 57 of Regulation (EU) 2019/6.
Oversight without ownership
Most marketing authorisation holders do not own their distribution chain. That does not remove their interest in it. The practical mechanism is contractual and auditable: quality agreements that define responsibilities explicitly, periodic audit of distributors proportionate to risk, agreed reporting of excursions and incidents, and a right of access that is exercised occasionally rather than merely reserved.
How PQRA helps
PQRA audits and qualifies distributors of veterinary medicinal products, drafts and reviews quality agreements, assesses temperature control and traceability arrangements, and prepares distribution operations for inspection by national competent authorities. We also support companies establishing distribution into Greece for the first time.
For a review of your veterinary distribution chain, contact PQRA.
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