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EU Regulatory Affairs for Animal Health & Nutrition

Regulatory affairs for animal-health and nutrition products in the EU

Register, maintain and expand your veterinary medicines and feed additives in the EU, from marketing authorisations under Regulation (EU) 2019/6 to feed additive authorisations under Regulation (EC) No 1831/2003.

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Veterinary medicines & feed additives
Registrations, variations & renewals
Service in English, Spanish & German
A partnership

A regulatory partner that works as part of your team

DGF works as part of your team: your regulatory and pharmacovigilance function if you don't have one, and extra senior hands if you do. Across veterinary medicines under Regulation (EU) 2019/6 and feed additives under Regulation (EC) No 1831/2003, we take on the day-to-day regulatory work, from authorisations and variations to your QPPV and dossiers, so your team can focus on the science and the market.

Close-up of medicine tablets and capsules
Veterinary medicines Regulation (EU) 2019/6
Regulatory affairs

Marketing authorisations & registrations

New registrations and market entry for veterinary medicinal products under Regulation (EU) 2019/6, across national, decentralised (DCP), mutual-recognition (MRP) and centralised procedures.

Variations & lifecycle maintenance

Variations (VNRA and VRA), renewals and Union Product Database (UPD) maintenance, keeping your marketing authorisations current and compliant.

SPC, labelling & product information

Summary of product characteristics, package leaflet and labelling: drafting, updates and alignment with Regulation (EU) 2019/6 product-information requirements.

Regulatory intelligence & change monitoring

We track regulatory changes, guidance and new requirements affecting your portfolio, so you adapt before deadlines become problems.

Pharmacovigilance

QPPV services

Named or deputy Qualified Person Responsible for Pharmacovigilance for your EU veterinary marketing authorisations. Resident in the EU, available to competent authorities.

Adverse event case processing

We handle intake, validation, VeDDRA coding, ABON causality assessment, follow-up, and EVVet submission within the 30-day regulatory timeline.

Signal management

Continuous monitoring of your pharmacovigilance data, signal detection and evaluation, and preparation of the annual benefit-risk review report for IRIS submission.

Literature monitoring

We screen PubMed, CAB Abstracts, and key veterinary journals by active substance and target species. Biweekly or monthly, with full documentation.

Feed Additives and Animal Nutrition Regulation (EC) No 1831/2003

Authorisations & dossiers

New feed additive authorisations under Regulation (EC) No 1831/2003: category classification, dossier compilation to Regulation (EC) No 429/2008, and submission to EFSA via the E-Submission Food Chain Platform.

Renewals & modifications

Ten-year renewals, due one year before expiry, plus modifications such as new target species or conditions of use, keeping your authorisations valid across the EU and EEA.

Labelling & marketing compliance

Labelling and placing-on-the-market compliance for additives and premixtures under Regulation (EC) No 1831/2003 and Regulation (EC) No 767/2009.

Regulatory intelligence & holder support

EU Register tracking, change monitoring, and acting as or supporting the authorisation holder's regulatory point of contact.

Why DGF

Built for animal-health and nutrition companies who need regulatory done right

Four ways DGF strengthens your regulatory team.

1

Animal-health and nutrition focus

We work only in animal-health and nutrition regulation. Our SOPs, templates and expertise are built around Regulation (EU) 2019/6 and Regulation (EC) No 1831/2003, so your team gains support that already knows the field.

2

Trilingual service

We work in English, Spanish and German. When your team deals with EMA, BVL or AEMPS, there is no translator in the room.

3

Regulatory and clinical background

I trained as a veterinarian, then worked in regulatory affairs at a national competent authority, then in industry. Your team gets someone who knows how both sides read a dossier and what inspectors look for.

4

Extra capacity when the workload spikes

New registrations, variation and renewal waves, an inspection, or a colleague on leave. We step in project-based, per case, or as interim cover, so deadlines are met without a permanent hire.

Not sure where your products stand under Regulation (EU) 2019/6?

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FAQ

Common questions from MAHs

Do I need a QPPV if I only have one or two products?
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Yes. Regulation (EU) 2019/6 requires every Marketing Authorisation Holder to designate a Qualified Person Responsible for Pharmacovigilance, regardless of portfolio size. The QPPV must be resident in the EU and accessible to competent authorities at all times. There is no minimum product threshold.
What is the difference between a named QPPV and a deputy QPPV?
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The named QPPV is the primary point of responsibility listed in your PSMF and notified to the competent authority. A deputy QPPV provides cover during absences. DGF can serve as either. We can act as your named QPPV, as a deputy to an in-house QPPV, or provide both.
How are adverse events reported to you by veterinarians or product users?
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We set up a dedicated pharmacovigilance contact channel for your organisation, typically an email address listed on your product packaging and SmPC. Reports received through that channel, through your sales team, or through national pharmacovigilance systems are all captured and processed within the required timelines.
What is a PSMF and do I need to maintain one?
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The Pharmacovigilance System Master File describes your PV system in full: the QPPV, the IT systems, the SOPs, staff lists, and audit history. It must be kept current and produced to competent authorities on request, including during inspections. DGF maintains your PSMF as part of retainer engagements.
How much does outsourced PV support cost?
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It depends on portfolio size, expected case volume, and what services you need. We offer retainer pricing for predictable monthly costs, per-case pricing for low-volume portfolios, and project pricing for defined tasks like PSMF set-up or dossier work. A short 20-minute call is the best starting point — it gives you a clear picture of your obligations and we can build a proposal from there.
Can DGF take over an existing PV system from another CRO?
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Yes. Transitions between PV service providers are straightforward when managed carefully. We conduct a handover review to assess the current state of your PSMF, case database, and outstanding submissions. A transition plan is agreed with you and the outgoing provider before any formal change of QPPV is notified to the competent authority.
Resources & insights

Guidance from the DGF team

Free, plain-language references on veterinary pharmacovigilance, EU regulation, and animal health compliance.

Free guide · ~12 min read

The Ten Essentials of Veterinary Pharmacovigilance

A primer for Marketing Authorisation Holders in the EU and UK — Regulation (EU) 2019/6, QPPV duties, reporting timelines, causality assessment, VeDDRA and the EU digital systems.

Read the guide →
Browse all guides →
Pharmacovigilance

PSMF: the document everyone ignores until inspection day

Inspectors don't ask if you have a PSMF. They ask to see it — and they read it. Here's what a real, inspection-ready master file looks like.

11 Jun 2026 Read on LinkedIn →
Pharmacovigilance

Why veterinary adverse events are underreported

Estimated reporting rates for veterinary adverse events sit in single digits — a real safety problem, and one every MAH can help fix.

16 Jun 2026 Read on LinkedIn →
Pharmacovigilance

The QPPV's real day: it's not just signing documents

People assume the QPPV signs documents. The actual job — signal oversight, readiness, being the authorities' point of contact — is much broader.

18 Jun 2026 Read on LinkedIn →
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About

Your partner in EU veterinary compliance

Founder · DVM, MSc

I trained as a veterinarian and moved into regulatory affairs. I have worked on the evaluation side at a national competent authority and on the industry side for animal health and crop protection products. I know how the EU market access process works from both ends.

I set up DGF because there is a real gap in the EU veterinary market. Most MAHs need solid pharmacovigilance but do not have the volume or the budget for a large CRO. That is the space we work in.

Based in Hamburg, Germany.

DVM — Universidad de La Salle MSc Agricultural Sciences — University of Bonn (DAAD) LS Academy Veterinary PV Certificate EU Regulation 2019/6 EVVet / IRIS
Get in touch

Let's talk about your regulatory and PV needs

Tell us about your situation and we will respond within one business day. No obligation, no sales pitch.