Veterinary Medicines: GMP and Pharmacovigilance

Antimicrobials

Article 107 restricts antimicrobial use in animals. Antimicrobials may not be applied routinely or to compensate for poor hygiene, husbandry, care or farm management, and may not be used to promote growth or increase yield. Prophylaxis is permitted only in exceptional cases for an individual animal or a restricted number of animals when the risk of infection is very high and the consequences likely to be severe; for antibiotics, prophylaxis is limited to an individual animal. Metaphylaxis — treating a group after disease is diagnosed in part of it — is allowed only when the risk of spread is high and no appropriate alternative exists.

The Commission designates antimicrobials reserved for treatment of certain infections in humans (Article 37(5)), and products containing them may not be used outside the terms of their marketing authorisation (Article 107(5)). For a manufacturer or marketing authorisation holder, these rules shape labelling, indications and the evidence needed to support them.

Manufacture and Active Substances

A manufacturing authorisation holder must have at least one qualified person, give 30 days’ notice before replacing them, keep samples of each batch, supply only wholesale distributors, report suspected falsified products immediately, and comply with GMP for veterinary medicinal products (Article 93(1)). It must use only active substances made under GMP and distributed under GDP, verify that its EU active-substance suppliers are registered, and audit them on the basis of a risk assessment.

Importers, manufacturers and distributors of active substances used in veterinary medicines register with their competent authority at least 60 days before starting, and comply with GMP or GDP as applicable (Article 95). The authority may decide to inspect within those 60 days, and then the activity may not start until it is cleared. Commission Implementing Regulation (EU) 2021/1280 sets the GDP for these active substances.

The GMP itself now has its own legal text. Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 lays down GMP for veterinary medicinal products under Article 93(2), with additional requirements for sterile and aseptic manufacture (Annex I), biological and immunological products (Annex II) and specific product types such as products for incorporation into medicated feed, ectoparasiticides for external application and medicinal gases (Annex III). Implementing Regulation (EU) 2025/2154 does the same for active substances used as starting materials, and the Commission’s EudraLex Volume 4 page records both in application since 16 July 2026. The requirements remain aligned with human-medicine GMP, but the legal basis is now the veterinary regulation.

Pharmacovigilance

Each marketing authorisation holder runs a pharmacovigilance system described in a pharmacovigilance system master file, designates a qualified person for pharmacovigilance who resides and operates in the Union, and complies with good pharmacovigilance practice for veterinary products (Article 77). It records every suspected adverse event reported to it — in the Union, in third countries or in the literature — in the Union pharmacovigilance database without delay and within 30 days of receipt (Article 76(2)).

Article 81 requires a signal management process. The holder runs it on its products, taking account of sales data and other pharmacovigilance data, notifies a change to the benefit–risk balance or a new risk within 30 days, and records the results, with a benefit–risk conclusion, in the database at least annually. VICH GL24 harmonises the management of adverse event reports, and VICH GL9 sets good clinical practice for veterinary clinical studies.

The US: New Animal Drugs

In the US, new animal drugs are approved through new animal drug applications (NADAs) or abbreviated applications (ANADAs) overseen by FDA’s Center for Veterinary Medicine. Under 21 CFR 514.80, applicants file a three-day field alert report within 3 working days of first becoming aware of a product or manufacturing defect that may result in serious adverse drug events, and a fifteen-day alert report within 15 working days of first receiving information on each serious, unexpected adverse drug event. Nonapplicants forward adverse drug experience reports to the applicant within 3 working days.

The working days and the defect report make the US clock different from the EU’s 30-day recording. A company selling in both needs one intake process feeding two sets of clocks, not two separate systems.