Ireland is the only English-speaking member of the EU and the Eurozone. Many of the world’s leading pharmaceutical and biopharma companies have operations here. Ireland hosts over 50 FDA-approved pharmaceutical and biopharma manufacturing plants, and the local competent authority, the HPRA, maintains a close working relationship with both the EMA and the FDA.
For companies based in North America, Ireland offers a familiar business environment with direct transatlantic connectivity, a better time zone overlap with both North America and continental Europe, and a regulatory system fully aligned with EU pharmaceutical legislation. Similarly, for UK companies, Ireland has become the most practical EU entry point since Brexit.
From a regulatory standpoint, an EU base in Ireland means you can appoint an EU QPPV, certify and release batches through an Irish MIA holder, obtain a Wholesale Distributor Authorisation under HPRA, and use Ireland as the starting point for decentralised or mutual recognition procedures across all EU member states. The HPRA is an active participant in EMA centralised procedures and routinely acts as Concerned Member State in DCPs.
Our teams in Ireland bring the expertise and infrastructure to make that EU base operational. We not only provide strategic and practical advise on the route into Ireland and the EU; we hold Manufacturing and Importation Authorisations (MIA) issued by the Irish regulatory competent authority (HPRA) as a site of batch release for both commercial and investigational medicinal products, fill the compliance roles, and run the day-to-day regulatory, pharmacovigilance and quality assurance operations.
Every batch of medicinal product placed on the EU market must be certified by a Qualified Person (QP) named on a MIA. The QP verifies that the batch was manufactured and tested in compliance with GMP, that it conforms to the marketing authorisation, and that it is fit for release. Without QP certification, product cannot legally enter the EU supply chain.
We hold MIAs with named QPs and support both commercial and clinical supply. Our QPs review manufacturing and analytical data, verify GMP compliance across the supply chain, and perform batch certification in line with regulatory requirements. All activities are supported by established quality systems and documentation expected during inspections.
We also support companies in establishing their own MIA in Ireland (and elsewhere). This includes Quality Management System design, supply chain qualification, liaison with the HPRA, and management of the application and inspection process. We can provide named QPs for the licence and continue to support compliant operation post-authorisation, including ongoing batch certification and inspection readiness.
EU legislation requires every marketing authorisation holder to have a Qualified Person for Pharmacovigilance who resides and operates within the EU. The QPPV is personally responsible for the oversight of the entire pharmacovigilance system: safety signal evaluation, PSMF accuracy, reporting compliance, and readiness for regulatory inspections. This is not an administrative appointment. Regulators expect the QPPV to have real-time oversight of the safety profile of every product under their responsibility.
Our EU QPPV capability is based primarily in Ireland, with additional QPPV resources in Germany and Portugal. We provide named EU QPPVs through our Irish entity, with 24/7 availability and documented deputy arrangements. Our QPPVs maintain the PSMF, oversee signal detection and aggregate reporting workflows, review risk management plans, and represent the MAH during pharmacovigilance inspections. For companies entering the EU without an existing PV infrastructure, we build the system from the ground up: PSMF, safety database configuration, case processing workflows, and authority registration.
A marketing authorisation on its own does not make a company operational in the EU. The MAH must have pharmacovigilance systems in place before the first product reaches a patient, named compliance personnel registered with the relevant authorities, quality systems that meet EU GMP and GDP requirements, and distribution infrastructure that can handle serialisation, temperature control, and traceability. These obligations begin at the point of authorisation and continue for as long as the product is on the market.
We set up and maintain that operational structure from Ireland. This includes QPPV appointment and PSMF creation, safety database setup and case processing workflows, authority registrations (EudraVigilance, XEVMPD/OMS), QP certification through our Irish MIA, and ongoing compliance management: variations, renewals, safety reporting, and authority correspondence. For companies that need an EU-based MAH entity, we advise on the options and work closely with legal and corporate structuring partners.
Wholesale distribution of medicinal products in the EU requires a Wholesale Distributor Authorisation (WDA) and a named Responsible Person (RP) who oversees GDP compliance at the licensed site. This is a personal, named role with direct regulatory accountability to the HPRA, responsible for ensuring that all distribution activities meet EU GDP requirements.
For companies that need a WDA or MIA in Ireland, we manage the full process: HPRA application, GDP and/or GMP quality system design, supply chain and manufacturing setup, and support through the HPRA inspection. We support clients in establishing their own Irish licences and provide named Responsible Person (RP) and Qualified Person (QP) services as required. Once the licence is granted and operations are live, ongoing compliance and inspection readiness are supported by our Quality & Compliance team.
Most companies entering the EU through Ireland do not stop at a single market. A decentralised procedure filed with HPRA as CMS gives you marketing authorisations across multiple member states in a single assessment. Variations, safety updates, and renewals then need to be coordinated across every country where the product is authorised.
We manage that coordination through our offices in Germany, Portugal, UK, and Switzerland, and through regulanet® members and partners in 90+ countries. One contract, one relationship, and a single point of coordination for the entire product lifecycle.
→ Central service pages: Legal Representation | QPPV | RP & Import Services
Tell us where you are based and what you need, and we will outline how Ireland works as your EU regulatory base.
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