Choosing a CDMO in Ireland means matching your product and stage to a site that holds the right HPRA manufacturing authorisation, has a clean inspection record in the EU and, if you supply the US, with the FDA, can provide Qualified Person batch release, and will sign a quality agreement that keeps you in control of outsourced work.
- Manufacturing or importing medicines in Ireland requires a manufacturer's/importer's authorisation (MIA) from the HPRA, and the HPRA points buyers to the EU's EudraGMDP database to check it.
- Each batch of finished product must be certified by a Qualified Person (QP) within the EU before release for sale, supply or export, under EU GMP Annex 16.
- EU GMP Chapter 7 makes the client (the "Contract Giver") responsible for assessing the legality, suitability and competence of a contract manufacturer before outsourcing.
- The FDA has recognised the HPRA's human drug inspections under the US-EU Mutual Recognition Agreement since 1 June 2018, with some product types excluded.
- Medical and pharmaceutical products made up 53.2% of Ireland's goods exports in 2025 (CSO).
Why overseas teams look at Ireland for contract manufacturing
Ireland has a large, regulated pharmaceutical manufacturing base. The Central Statistics Office reports that exports of medical and pharmaceutical products rose by 39.0% to €138.6 billion in 2025, representing 53.2% of total goods exports (CSO, Goods Exports and Imports December 2025). Alongside large company-owned plants, Ireland has a network of contract development and manufacturing organisations (CDMOs).
The regulator is the Health Products Regulatory Authority (HPRA). In 2025 it completed 108 good manufacturing practice (GMP) inspections at sites producing human medicines or active substances (HPRA 2025 annual report). For teams supplying the US, the FDA recognised the HPRA for human drug inspections on 1 June 2018 under the US-EU Mutual Recognition Agreement (FDA).
Start by defining exactly what you need
Before you contact any site, write down:
- Modality: small molecule, peptide, biologic, cell or gene therapy. Each needs very different facilities.
- What is being made: active substance, finished dosage form, or both, and the dosage form itself (oral solid, sterile injectable, topical, inhaled).
- Scale and volume: batch size, batches per year and expected growth.
- Stage: preclinical, clinical (investigational medicinal products) or commercial.
- Markets: EU only, US, or other regions, as this decides which inspections and registrations matter.
- Services: development, analytical testing, stability, packaging, QP release, storage and distribution.
Stage matters for licensing. The HPRA issues separate authorisations for human medicines, veterinary medicines and investigational medicinal products used in clinical trials (HPRA). Check that the site holds the one your stage needs.
How do you check that an Irish CDMO is licensed?
EU law requires an authorisation for total and partial manufacture, including packaging, and for imports from outside the EU (Directive 2001/83/EC, Article 40). In Ireland this is applied through the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539/2007). The HPRA states that manufacturers need an MIA "before they can certify or release any products processed or imported", and that it issues a GMP certificate after each inspection where compliance is satisfactory (HPRA).
The HPRA does not routinely issue hard copies of MIAs and directs users to EudraGMDP, where electronic authorisations can be verified (HPRA). EudraGMDP is the EU database of manufacturing and import authorisations and GMP certificates, with a public version available since 2011 (EMA). It also records GMP non-compliance statements. Check that the listed activities and dosage forms cover your product, not just that a licence exists.
Checking FDA inspection history if you supply the US
If the product will be sold in the US, look at the FDA record as well. The FDA Data Dashboard lets you search inspections by firm and see their classification: No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). The FDA notes the datasets include only final actions and exclude some inspections, including pre-approval inspections. Search the FDA warning letters database by company name, and check whether any letter has a close-out letter posted. The Drug Establishments Current Registration Site shows whether a site is currently registered with the FDA.
Note the limits of the Mutual Recognition Agreement. The FDA lists vaccines for human use, plasma-derived products and advanced therapy medicinal products as outside its scope, and pre-approval inspections are also excluded (FDA). A site making those products for the US should expect direct FDA oversight.
Understanding QP certification and batch release
Every MIA holder must have at least one Qualified Person permanently and continuously available (Directive 2001/83/EC, Article 48). Under Article 51, the QP ensures each batch is made and checked in line with the law and the marketing authorisation. For products coming from outside the EU, each batch must undergo full qualitative analysis and quantitative analysis of at least all active substances in a Member State, unless an appropriate EU arrangement with the exporting country applies.
EU GMP Annex 16 sets out how this works in practice: each batch of finished product must be certified by a QP within the EU before release for sale, supply or export, and certification can only be done by a QP of a manufacturer or importer named in the marketing authorisation (Annex 16). If you are entering the EU from the US or Asia, ask early whether the CDMO can act as your importer and QP release site, and whether it can carry out import testing.
Capacity, timelines and technology transfer
Ask for specifics rather than general assurances: which suite or line your product would use, when the first available slot is, how long qualification and validation will take, and what happens if another client's project overruns. Ask how analytical method transfer and stability studies will be scheduled.
Technology transfer deserves its own plan. The WHO guideline on technology transfer in pharmaceutical manufacturing covers due diligence and gap analysis, quality risk management, documentation, premises, equipment, and qualification and validation (WHO TRS 1044, Annex 4). Use it as a checklist when you compare how each CDMO proposes to receive your process.
What should the quality agreement cover?
EU GMP Chapter 7 requires a written contract between the Contract Giver and the Contract Acceptor that "clearly establishes the duties of each party" (EudraLex Volume 4, Chapter 7). The client stays responsible for assessing the contractor before outsourcing and for monitoring its performance afterwards. Under Chapter 7, the agreement should:
- state who does each step, including technology transfer, purchasing and testing of materials, production, in-process controls and release;
- keep all manufacturing, analytical and distribution records, and reference samples, held by or available to you;
- permit you to audit the contractor and its agreed subcontractors;
- bar subcontracting without your prior evaluation and approval;
- prohibit unauthorised changes that could affect quality.
Commercial terms to agree before you sign
Clarify how pricing is built (per batch, campaign or hour), how change orders are approved, who owns process improvements and intellectual property, who pays for a failed batch, minimum commitments, and what happens to your materials and documents if the relationship ends.
What to check and where to verify it
| What to check | Where to verify it |
|---|---|
| Manufacturing or import authorisation and its scope | EudraGMDP public database, as directed by the HPRA |
| Current GMP certificate and any non-compliance statement | EudraGMDP |
| FDA inspection classifications (NAI, VAI, OAI) | FDA Data Dashboard |
| FDA warning letters and close-out letters | FDA warning letters database |
| Current FDA drug establishment registration | FDA Drug Establishments Current Registration Site |
| QP availability and release responsibilities | The MIA on EudraGMDP, the marketing authorisation and the quality agreement |
| Actual capability, equipment and practices | An on-site audit by an independent qualified auditor or QP |
Red flags to watch for
- A licence on EudraGMDP that does not list your dosage form or activity.
- A GMP non-compliance statement, or OAI classifications and warning letters without a posted close-out.
- Reluctance to permit an audit, or to name subcontractors.
- No clear answer on which QP will certify your batches.
- Capacity promises without a named line, suite or start date.
- Pressure to sign a supply contract before the quality agreement is agreed.
A short CDMO selection checklist
- Written brief: modality, dosage form, scale, stage, markets and services.
- MIA and GMP certificate checked on EudraGMDP, with scope matching your product.
- FDA inspections, warning letters and registration checked, if supplying the US.
- QP release and EU import testing arrangements confirmed in writing.
- Technology transfer plan, gap analysis and timeline agreed.
- Quality agreement aligned with EU GMP Chapter 7.
- Independent facility audit completed before commitment.
- Commercial terms reviewed by your own advisers.
Frequently asked questions
Does a CDMO in Ireland need a licence from the HPRA?
Yes. Manufacturing or importing medicines in Ireland requires an HPRA manufacturer's/importer's authorisation, with a separate one for clinical trial products. You can verify it on EudraGMDP.
Can an Irish CDMO release our product for the EU market?
It can if its authorisation covers the activity and it is named as the batch release site in your marketing authorisation, so that its QP can certify each batch.
Will the FDA inspect an Irish site that makes our US product?
The FDA recognises HPRA inspections for many human drugs, but pre-approval inspections, vaccines, plasma-derived products and advanced therapies fall outside the Mutual Recognition Agreement.
Is a GMP certificate enough proof of quality?
No. It confirms a satisfactory inspection at a point in time. EU GMP Chapter 7 still makes you responsible for assessing the contractor's suitability and competence, so an audit focused on your own product is still advisable.
Who should audit a CDMO before we sign?
A suitably qualified GMP auditor or QP who is independent of the CDMO. The audit should cover your specific product, process and the systems that support it.
Can the CDMO use subcontractors for parts of our work?
Only with your prior evaluation and approval, according to EU GMP Chapter 7. Ask for a list of subcontracted activities, such as testing or sterilisation, before you sign.
What to do next
Priya Life Science's free CDMO directory lists Irish contract manufacturers, and the Ireland pharma map shows where pharmaceutical sites are located. Verify every candidate against EudraGMDP and, where relevant, FDA records before you shortlist.
If you would rather not run the search alone, Priya Life Science's independent CDMO and CRO sourcing service can shortlist Irish CDMOs against your requirement, make introductions and coordinate an independent facility assessment. The audit itself is carried out by an independent qualified auditor or QP, not by Priya Life Science. There is no cost to enquire.
Sources
- Central Statistics Office: Goods Exports and Imports December 2025, key findings
- HPRA: HPRA publishes 2025 annual report
- HPRA: Regulation of manufacturing, medicines for human use
- HPRA: Authorisation to manufacture medicines in Ireland
- S.I. No. 539/2007, Medicinal Products (Control of Manufacture) Regulations 2007
- Directive 2001/83/EC on the Community code relating to medicinal products for human use (Articles 40, 48 and 51)
- European Commission: EU GMP Annex 16, Certification by a Qualified Person and Batch Release
- European Commission: EudraLex Volume 4, including Chapter 7, Outsourced Activities
- European Medicines Agency: EudraGMDP database
- EudraGMDP public database
- FDA: European Union Mutual Recognition Agreement
- FDA Data Dashboard: Inspections
- FDA: Warning Letters
- FDA: Drug Establishments Current Registration Site (DECRS)
- WHO: TRS 1044, Annex 4, guidelines on technology transfer in pharmaceutical manufacturing
