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Case study · 02
A comprehensive platform that takes a medicinal product from first authorisation request through every variation, renewal and revocation, keeping the national authority and the European Medicines Agency in lockstep, without spreadsheets.
Impact
In Portugal, the Medicines Lifecycle platform is the operational system DGAV uses to run veterinary medicines regulation end to end. The same authoritative product data validates every prescription written in PEMV in real time and feeds substance-level analysis aligned with the EMA AMEG classification, supporting stewardship reporting that depends on the registry and the prescription system speaking the same language.
2,900+
MEDICINES REGISTERED
Veterinary medicinal products under active lifecycle management in Portugal.
13,000+
PACK SIZES
Distinct authorised presentations tracked at the pack level.
1,535+
ACTIVE SUBSTANCES
Substance-level granularity, supporting AMEG classification and substance-level surveillance.
EMA-aligned
DATA ALIGNMENT
Structured against EMA standards from day one.
Challenge
A regulatory authority for veterinary medicines does not just hold a list of approved products. It runs a continuous workflow: marketing authorisation procedures, post-authorisation variations under EU Regulation 2019/6, suspensions and revocations, quality defect investigations, supply notifications, and ongoing data submissions from marketing authorisation holders and wholesalers. When that workflow lives across email, spreadsheets, and disconnected systems, compliance becomes manual and the authority's record drifts from reality.
Approach
OneAiQ built the Medicines Lifecycle platform to carry the entire regulatory workflow for veterinary medicinal products in a single environment. The system covers the full marketing authorisation procedure and every post-authorisation change category defined by EMA, including Type IA, Type IA(IN), Type IB, and Type II variations, plus extensions, renewals, transfers, suspensions, and revocations. A dedicated MA Holder portal lets pharmaceutical companies submit applications, variations, supply notifications, and required periodic data directly to the regulatory authority, with structured validation at submission. A wholesaler interface captures distribution and sales reporting against the same authoritative product master. Quality defect reports enter the same case management workflow, are tracked to resolution, and are linked to the affected products and batches. Every regulatory request carries a deadline, an owner, and a documented compliance trail.
01 · Authoritative registry
Structured around authorisations, variations, renewals, and revocations, with every lifecycle event tracked against the same record.
02 · Suite backbone
Acts as the secure data foundation of the entire OneAiQ suite, supplying verified product lists to downstream validation and surveillance systems.
A medicines registry is too narrow a frame for what a regulatory authority actually does. What the authority needs is a system that sustains its work: the procedures, the deadlines, the submissions, the defects, the variations, and the audit trail behind each decision. When the operational platform and the reference data are the same system, downstream uses (prescription validation and stewardship reporting) stop being integration projects and start being structural properties.
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Managing medicinal product approvals, variations, and revocations requires absolute regulatory precision and EMA-alignment. If you are looking to upgrade your state database with secure, multi-tenant digital infrastructure, get in touch to schedule a technical walkthrough.
