Maturity Regulation (EU) 2019/6 · Veterinary medicines compliance
Your veterinary medicine practices, measured against Regulation 2019/6 and turned into a costed action plan.
10 themes, a 5-level scale. And the action that moves each level to the next.
The framework’s 10 themes, already written from L1 to L5. One company, one business unit, or 300 at once.
Maturity Regulation (EU) 2019/6 · Veterinary medicines compliance
10 themes, 5-level scale.
Nordhavn Industries
53 / 100
They measure their maturity with Datamensio
An example
This could be your situation.
Take one company as an example: three sites, three spreadsheets, no shared answer.
Nobody can consolidate.
Nordhavn Industries, 2,400 people in Hamburg, Lyon and Porto. A client asks where the group stands. Each site answers in its own spreadsheet, with its own scales.
Three weeks, a single base.
One Regulation (EU) 2019/6 on veterinary medicinal products, applicable since 28 January 2022 assessment launched across all three sites at once, from the managers’ interview notes. The framework was already written, its 10 themes and levels L1 to L5 too.
Two costs avoided before being committed.
A score of 53 out of 100, with the gap concentrated on three themes. The AI companion spotted that two actions duplicated those of another audit. The committee report took one sentence to request.
What it saved them
- 3sites measured on the same base, instead of three questionnaires to reconcile
- 2duplicate actions caught before the spend
- 1committee report, with no manual rework
These figures are an example. They could be yours.
The standard imposes processes. Datamensio says where you stand.
01
The framework is already written
Themes, questions and levels L1 to L5, all written. You do not start from an empty spreadsheet.
02
The score lands the same day
Online, by self-assessment link or in interview. Theme by theme, comparable over time.
03
The gap becomes a costed plan
Every step up carries its action. The AI prioritises on expected effect, not on the order of the standard.
04
Progress can be demonstrated
Campaign after campaign, against your target and against your own past. That is what your board asks for.
The maturity scale
One level, the next, and the action that links the two.
It is this mechanism, a level, a level above, and the action linking the two, that turns a finding into a trajectory.
Are treatments administered recorded in a way that can be reconciled with the products acquired and the animals concerned?
- N1
No structured recording. Treatments are noted on scattered records, with no link to animals or to product purchases.
- N2
A register exists and is kept, but information is incomplete for some batches and reconciliation with delivery notes is only done when an inspection occurs.
- N3
The register is kept in a single format, completed at each administration with animal or batch, product, dose and operator. Reconciliation with product receipts is carried out periodically.
- N4
Records are centralised, discrepancies between products acquired and products administered are analysed and documented, and the data feeds directly into usage indicators by species.
- N5
The system is reviewed in line with internal control findings and regulatory changes, with documented tracking of revisions and comparison across sites and campaigns.
Action to move from L2 to L3
Impose a single register format across all sites, make the fields animal or batch, product, dose and operator mandatory, and place the register / delivery note reconciliation on the agenda of the veterinary health visit.
« With Datamensio, we meet our objectives far more efficiently. The ERDF inspection services and our supervising ministry particularly appreciated an approach that gives them reliable data. »
Director, CCI 94CCI Île-de-France
« We believe this is the most suitable solution to scale our transformation project and measure impact according to our needs. »
Maja SucekChief Operating Officer, Interreg Danube
Rarely on its own
Frameworks combine. Put several together to cover your business, or have the AI write yours.
Take your first measurement
What this framework covers
Regulation (EU) 2019/6 replaced Directive 2001/82/EC and has applied since 28 January 2022. It covers the entire lifecycle of veterinary medicinal products: marketing authorisation, manufacturing, wholesale distribution, retail sale, prescribing, administration to animals, and pharmacovigilance. It requires the keeping of acquisition and administration records, governs off-label use through the therapeutic cascade, bans routine preventive use of antimicrobials, and makes the collection and reporting of antimicrobial sales and usage data by species mandatory.
The difficulty is rarely knowing the text. It is knowing where things stand, site by site. Are treatment records usable and reconcilable with delivery notes, or reconstructed on demand for the inspector? Are withdrawal periods genuinely tracked through to the decision to dispatch animals or milk? Who checks that the prescription covers every product held in the medicine cabinet of the farm or the integrated livestock site?
One confusion comes up often. Regulation 2019/6 governs the medicinal product itself and its use. Regulation (EU) 2019/4 covers medicated feed, and Regulation (EU) No 37/2010 sets maximum residue limits for pharmacologically active substances. The three texts meet on the ground, in the same cabinet and on the same batch of animals, but their documentary obligations do not overlap. An organisation that is strong on residues can be weak on prescription traceability.
An official inspection concludes with a binary finding: compliant or non-compliant on the point checked. The maturity assessment answers a different question. What level of control does each practice sit at, and what specific action moves it up to the next level. It is this reading that allows organisations to prioritise between sites, sequence investment, and track progress from one campaign to the next.
Within Datamensio, the framework is ready to use and adjustable. The AI tailors themes, questions and level wording to your sector, dairy cattle, poultry, pig, aquaculture or distribution, and can build a version derived from your treatment protocols, farm procedures and control plans.
Reference standard: Regulation (EU) 2019/6 on veterinary medicinal products, applicable since 28 January 2022
The themes assessed
Governance and responsibilities
Appointment of those responsible for medicines, coordination between veterinarian, farmer and processing site, written procedures, training and authorisation of staff administering treatments.
Procurement and storage
Authorised purchasing channels, supplier compliance, storage and temperature conditions, security of the medicine cabinet, segregation of expired products and returns management.
Prescribing and prescriptions
Issuing of the veterinary prescription, consistency with clinical examination and health monitoring, durations and dosages, retention of prescriptions and coverage of all products held.
Off-label use and the cascade
Application of the conditions of the therapeutic cascade, justification and traceability of the decision, withdrawal periods applied for off-label use, extemporaneous preparations.
Antimicrobial use
Ban on routine preventive use, control of metaphylaxis, first- and second-line protocols, antibiograms, substances reserved for human medicine.
Records and treatment traceability
Administration register, identification of treated animals or batches, dates, doses, operator, reconciliation with product receipts and usability of data.
Withdrawal periods and product release
Determination of withdrawal periods, marking and isolation of treated animals, holding of milk and eggs, checks before dispatch or slaughter, handling of deviations.
Pharmacovigilance and adverse events
Detection and recording of adverse events, reporting to marketing authorisation holders and authorities, monitoring of lack of efficacy, feedback loops.
Collection and reporting of usage data
Collection of volumes by species, reliability and completeness of data, calculation of exposure indicators, timely submission and consistency with records.
Internal controls and improvement
Self-inspection and document review plan, internal audits of farms and sites, handling of non-conformities, follow-up of action plans and comparison over time.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Is Regulation (EU) 2019/6 subject to certification?
No. It is a directly applicable EU regulation, checked by competent authorities through official inspections. The assessment measures the maturity of your practices and prepares for these inspections, it does not issue any certificate.
What is the difference between this assessment and a compliance audit?
An audit checks a specific point and concludes with compliance or a gap. The assessment positions each practice on a progressive scale and indicates the action that moves it up a level. The assessment prepares for the audit, the audit validates.
How long does the assessment take?
The short version takes 20 to 30 minutes to complete by a quality manager or a veterinarian. The full version, run collaboratively with sites and farmer groups, typically spans one to two weeks, most of the time being spent on data collection.
Can the framework be adapted to our sector?
Yes. Themes, questions and levels can be adjusted. The AI tailors the framework by species and production method, or builds a dedicated version derived from your treatment protocols and internal procedures.
How does this framework relate to Regulation 2019/4 and Regulation 37/2010?
Regulation 2019/6 covers the medicinal product and its use, 2019/4 covers medicated feed, and 37/2010 covers maximum residue limits. All three assessments share traceability data. A cross-cutting roadmap consolidates them without duplicating actions.
Can multiple sites or farmer groups be compared?
Yes. Each business unit or farm is assessed against the same framework, making scores comparable between entities and against previous assessments. The consolidated roadmap prioritises actions at sector level.
Is veterinary expertise needed to answer?
The questions cover organisation, traceability and procedures, not pharmacology. Some questions fall to the responsible veterinarian: the collaborative mode allows them to be assigned directly.
Where is the data hosted?
In France, with OVH, backed up with Scaleway. No transfer outside the European Union. The AI models used can be selected, including from European providers.