January 2027 deadline: EU Regulation 2019/6 requires electronic product information for all veterinary medicines. Implementation takes 3–6 months. The procurement window is closing.

AstraLabel CORE — Animal Health

January 2027 is six months away.
Is your veterinary labelling compliant?

AstraLabel CORE delivers GxP-compliant electronic leaflets for animal health MAHs with EU market presence. Ready in one month. No IT infrastructure investment required.

EU Reg 2019/6 compliantLive in 30 daysGxP-validatedGS1 Digital Link

Request a conversation

We respond within one business day.

REFERENCEABLE CUSTOMERS

Two PLA animal health membersLive in Spain — paper no longer required

The problem

Three facts every animal health regulatory team needs to know

01Paper is already gone in Spain. EU Regulation 2019/6 gave member states authority to require digital-only labelling. Spain exercised it. Veterinary medicines in Spain are governed by a digital-first framework — the competent authority accepts only QR-code-linked electronic product information. The rest of the EU follows by January 2027.
02Implementation takes 3–6 months. Platform selection, vendor qualification, quality agreement, content onboarding, GxP validation, regulatory submission. A well-organised regulatory team can do this in six months — but only if procurement completes in week one.
03Most platforms built for human health pharma were not designed for veterinary MAHs. They require months of IT integration, dedicated infrastructure teams, and implementation timelines measured in quarters. AstraLabel CORE does not.

The solution

AstraLabel CORE — built for animal health MAHs

A purpose-built, GxP-validated electronic labelling platform. Shared PLA-managed infrastructure. No IT team required on your side. XML conversion included. QR codes generated automatically. GS1 Digital Link compliant — the standard accepted by Spanish and EU regulators.

Ready in 30 days

From contract signature to live eLeaflets in one month. The fastest implementation path to EU Reg 2019/6 compliance in the market.

GxP-validated

Full SDLC-ready validation documentation. Shared GxP-validated infrastructure managed by PLA. No qualification burden on your IT team.

46 countries · 29 languages

Structured ePI distributed across all relevant regulatory repositories globally. GS1 Digital Link QR codes. Accessibility-first rendering.

Reference case

How our animal health members approached the Spain transition

Two PLA animal health member organisations deployed AstraLabel CORE for their Spanish veterinary product portfolios. Onboarding completed within two months in each case. Paper leaflets replaced with GS1 Digital Link QR codes — accepted by the Spanish competent authority as the compliant standard.

Both organisations are available as reference contacts for qualified animal health MAHs evaluating the platform — facilitated through PLA.

"Spain has already answered the question of whether this works. The regulatory environment is live. The standard is established. The only variable now is whether your organisation has a solution in place before January 2027."

— Stefan Schwarzfischer, Executive Director, PharmaLedger Association

Implementation path

What the timeline looks like from today

Month 1

Platform selection & procurement

Vendor qualification, quality agreement, contract. AstraLabel CORE procurement moves faster than enterprise alternatives — no dedicated IT team required on your side.

Month 2–3

Content onboarding

Existing leaflet library uploaded, structured, XML-converted. QR code generation configured. All performed by PLA team — no in-house development required.

Month 4–5

GxP validation & regulatory submission

Validation documentation delivered. Regulatory submission prepared. Market-specific QR code labelling configured.

Month 6

Go-live — ahead of the January 2027 deadline

eLeaflets live. QR codes printed. Paper replaced. EU Reg 2019/6 compliant.

By the numbers

AstraLabel at a glance

46Countries with active ePI distribution

29Languages supported

1Month to go live on AstraLabel CORE

Jan 27EU Reg 2019/6 enforcement deadline

Also for your role

Animal Health Human Health Artwork & Packaging Supply Chain CFO & Finance Legal & Compliance Regulatory Affairs

Common questions

Frequently asked questions

We are still evaluating options — we have time.

The procurement window is the constraint, not the technology. Quality agreement, legal review, and internal approvals at animal health MAHs typically take 2–4 months. AstraLabel CORE itself deploys in one month. That means you need to start procurement now to be live before January 2027 with confidence.

We only operate in one or two EU markets — are we in scope?

EU Regulation 2019/6 applies across all EU member states, not only Spain. Spain was the first to implement a digital-first enforcement posture. The regulation itself is EU-wide and the enforcement date is uniform. If you have veterinary medicinal products authorised in any EU market, you are in scope.

We are building our own electronic labelling solution.

AstraLabel CORE is live in 30 days. No build required. For animal health MAHs whose primary business is not pharmaceutical IT infrastructure, the build vs. buy calculation is straightforward — particularly with a hard regulatory deadline involved.

Can we speak with a reference customer directly?

For qualified prospects, PLA facilitates direct reference calls with our animal health member organisations who are live in Spain. Submit the form above and we will arrange it.

What does AstraLabel CORE cost?

CHF 18,750 setup fee plus CHF 2,250 per active leaflet per year. PLA Members receive a 10–20% discount. Implementation is included — no separate professional services cost.

The January 2027 deadline is fixed. The procurement window is not.

Request a 20-minute demonstration. We will show you how our animal health members managed the Spain transition and what the path looks like for your portfolio.

Request a demo — no obligation

January 2027 is six months away.Is your veterinary labelling compliant?