EU/EEA Regulatory Landscape
Across the EU/EEA, the requirement for batch certification by a Qualified Person (QP) is established in Directive 2001/83/EC (as amended, notably by Directive 2004/27/EC) and, for investigational products, Regulation (EU) No 536/2014. Every batch of medicinal product manufactured in, or imported into, the EU/EEA is certified by a QP prior to release for sale or supply. This is a personal legal obligation: the QP must ensure that each batch has been manufactured and tested in accordance with EU Good Manufacturing Practice (GMP) and complies with the terms of the relevant marketing authorisation or clinical trial authorisation.
QP eligibility and oversight in the EU are managed at Member State level, with each national competent authority (e.g. European Medicines Agency coordinating at EU level, alongside national authorities such as Health Products Regulatory Authority in Ireland) ensuring that QPs meet harmonised qualification criteria, including defined academic qualifications and practical experience. QPs must be named on the relevant Manufacturing and Import Authorisation (MIA) issued by the national authority. Certification by a QP named on an MIA ensures that the batch is compliant and can be released across the EU/EEA.
While the EU/EEA framework allows mutual recognition of QP certification between Member States, this does not extend to the UK following its departure from the EU. Consequently, companies placing products on both EU/EEA and UK markets must maintain appropriately qualified and authorised QPs within each jurisdiction.
What We Handle Locally
We provide EU-based Qualified Person (QP) certification and batch release services for both commercial and investigational medicinal products under our Manufacturing / Import Authorisations (MIA) and MIA-IMP.
Our HPRA-authorised QPs in Ireland are named on our MIAs and can also operate across client MIAs where required, offering a flexible and scalable QP model. This enables us to support organisations that do not have, or prefer not to maintain, an in-house QP function, while ensuring every batch is certified and released by a suitably authorised professional.
Our Ireland-based team supports a broad range of dosage forms, including biologics, oral solid dosage forms, liquids, and inhalation products. We also have extensive experience supporting clinical trials for non-EU sponsors. Through our established network of authorised importation sites and EU QC testing facilities, we deliver a fully integrated solution for batch testing, certification, and release.
In all cases, our QPs act in a statutory capacity and retain full personal responsibility for every batch they certify.
Our Services Include:
Commercial batch certification
End-to-end review of manufacturing and analytical documentation, including deviations and change controls, with certification prior to EU/EEA release.
IMP certification
Certification of investigational medicinal products, including protocol-specific manufacturing, blinding, comparator sourcing, and product specification file management.
Import verification
Oversight of importation from approved countries, ensuring appropriate certification and compliance prior to release to EU/EEA sites.
Third-country import certification
Full QP certification for products imported from non-approved countries, including GMP compliance assessment, testing review, and supply chain verification according to Annex 21 requirements.
Managed access and unlicensed supply
QP certification for products supplied under managed access programmes and other unlicensed supply pathways (early access programme (EAP) / compassionate use program (CUP).
Ongoing QP oversight
Support for vendor and CMO qualification review, assessment of process validation and cleaning validation, evaluation of temperature excursions and transport deviations, and participation in quality governance and management review.
Technology Transfer Oversight
Our QPs provide experienced oversight of technology transfer projects ensuring relevant Quality considerations are taken into account at an early stage in a project.
Ireland Operations
All our QPs are named on HPRA-issued MIAs. Certification performed in Ireland is valid across the EU/EEA, ensuring seamless batch release and compliance for commercial and clinical products.
| Jurisdiction | QP Arrangements |
|---|---|
| Ireland | QPs named on HPRA MIA. Certification under EU GMP Annex 16. Products certified in Ireland are valid across the EU/EEA. |
| Northern Ireland | Operates under Windsor Framework arrangements. EU QP certification is recognised. Specific labelling and supply chain requirements apply. |
Need a QP?
Tell us about your product portfolio, manufacturing arrangements, and what you need, and we will outline what we can provide.
Contact UsKey Regulations
The regulatory framework for QP services in Ireland.
Frequently Asked Questions (FAQs)
For general questions about QP responsibilities, batch certification processes, and GMP compliance, see the FAQs on Quality & Compliance.
Do I need an EU QP now that the UK has left the EU?
Yes. Since 1 January 2021, UK QP certification is not recognised in the EU, and UK QP certification is not sufficient for the EU/EEA market. If you supply both markets, you need QPs in both jurisdictions. Our Irish-based QPs are named on Irish MIA licences.
How quickly can you provide a named QP for our MIA?
Timelines depend on the product portfolio and complexity. For straightforward engagements (a defined product range with established manufacturing and testing), we can typically have a QP named on the licence within weeks. The HPRA variation process to add a named QP to an existing MIA is usually faster than obtaining a new licence. Contact us with the specifics and we will give you a realistic timeline.
Can your QPs certify biological products?
QP certification for biological products requires specific expertise in aseptic processing, cold chain management, and traceability and chain-of-identity requirements. Our QP team’s specific product experience is outlined in the team profiles and covers biologic products.
Do you provide QP services for IMP clinical trial supply in the EU/EEA?
Yes. We certify IMP batches under EU/EEA GMP requirements. For IMPs imported from non-EU countries, we provide the QP oversight including verifying the compliance of the supply chain, reviewing product specification files, and confirming the IMP is approved for EU/EEA trial sites before release.