Veterinary medicines and animal health products

• Regulation (EU) 2019/6 — veterinary medicinal products
• Regulation (EU) 2019/4 — medicated feed
• Regulation (EU) No 528/2012 where the product is biocidal

Who has to appoint one

Anyone placing veterinary medicines on the EU market. As with human medicines, the authorisation holder must be established in the Union. Antiparasitics applied to animals are veterinary medicinal products; products applied to the animal's environment are usually biocides.

Thresholds and exemptions

None. Even products for companion animals sold over the counter require authorisation, and the route differs by species and indication.

What must appear on the label

Product name, active substances and strength, target species, dosage and route, withdrawal periods for food-producing animals, the authorisation number, batch number, expiry date, and the authorisation holder's details.

Marketplace fields

Marketplaces remove unauthorised veterinary products, and flea and worming treatments sold cross-border without authorisation are a persistent enforcement target because the products are commonly bought online.

Documentation you must hold

The marketing authorisation dossier, good manufacturing practice certification, batch release by a qualified person in the Union, pharmacovigilance system, and where the product is for food-producing animals, residue data supporting the withdrawal period.

Standards and testing

Quality, safety and efficacy studies per the authorisation route, residue depletion studies for food-producing species, and target animal safety studies.

Language requirements

Labelling and package leaflet in the language of each member state of sale.

When it applies

Authorisation before placing on the market, with the Union product database registration since 2022.

How long records are kept

Per pharmaceutical law, generally at least five years after expiry for batch records and longer for pharmacovigilance.

What happens if you do not comply

Withdrawal, criminal proceedings and, for food-producing animals, food chain consequences including seizure of produce. Antimicrobial products face additional restrictions given resistance policy.

Who enforces it

National veterinary medicines authorities and the European Medicines Agency, plus food safety authorities where food-producing animals are involved.

Where the boundary lies

A collar or spot-on that kills fleas on the animal is a veterinary medicinal product or, in some presentations, a biocide, and the classification differs between the two regimes with entirely different requirements. A grooming product with no antiparasitic action stays in general product safety law.

Questions we are asked

Is a flea collar a medicine?

Depending on the active substance and its mode of action, it is either a veterinary medicinal product or a biocidal product. Both require authorisation; neither accepts a representative substitute.

Can we sell supplements for animals instead?

Feed supplements are feed law, which requires a registered feed business operator in the Union but not a marketing authorisation. The claims must stay nutritional.