The technical content of a veterinary marketing authorisation application is governed by Annex II to Regulation (EU) 2019/6, as replaced by Commission Delegated Regulation (EU) 2021/805 of 8 March 2021. Teams arriving from human medicines recognise the shape of the dossier immediately and then discover that the content expectations diverge substantially, particularly on safety.
The structure
A dossier is organised in parts. Part 1 contains the summary of the dossier together with the administrative information set out in Annex I. Part 2 contains the quality documentation, covering the physicochemical, biological or microbiological information, including the description of the product, the method of manufacture, and the control of starting materials. The remaining parts address safety and efficacy.
The delegated regulation distinguishes between product types, setting out technical information requirements separately for veterinary medicinal products other than biological products, for biological products other than immunological products, and for immunological veterinary medicinal products. Choosing the wrong set is a structural error that surfaces at validation.
Where veterinary safety is broader
The safety package for a veterinary product has to address audiences that a human dossier does not:
- Target animal safety. Tolerance in the species being treated, at and above the intended dose.
- User safety. Risk to the person handling and administering the product, which is often a farmer or a veterinary nurse rather than a clinician.
- Consumer safety. For food-producing species, residue depletion assessed against established maximum residue limits, feeding into the withdrawal period.
- Environmental safety. Environmental risk assessment, which for products used in livestock or aquaculture can be substantial.
Each of these is a distinct evidence stream with its own study requirements and its own capacity to delay a programme if started late.
Guidance is part of the requirement
Documentation must be presented in accordance with Annex II and must take into account the guidance documents published by the Commission. Applicants are also expected to take account of the most up-to-date veterinary medicinal knowledge and the scientific guidelines on quality, safety and efficacy published by the European Medicines Agency. In practice, a dossier that satisfies the letter of Annex II but ignores current scientific guidance will attract questions.
Planning the package
Three decisions shape the work more than any others: which species and indications the product will carry, whether any of those species are food-producing, and which product type category applies. Settle those early and the data requirements follow logically. Leave them open and the programme expands unpredictably.
How PQRA helps
PQRA designs and compiles veterinary marketing authorisation dossiers under Annex II, including gap analysis of existing data packages, planning of target animal safety, user safety, residue and environmental studies, and preparation of the full submission. We support new applications, line extensions and the remediation of legacy dossiers that no longer match current expectations.
For support with your veterinary dossier, contact PQRA.
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