Qualified Person Services for EU Market Entry: A Guide for Non-EU Pharma Companies
A practical guide for non-EU pharmaceutical and biotech companies navigating EU batch release, QP declarations, and GMP compliance.
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Every batch of medicinal product intended for sale or supply in the EU/EEA must be certified by a Qualified Person (QP) before release. If your company manufactures outside the EU/EEA, this requirement must be built into your market-entry and clinical-trial supply strategy from the outset. Getting it wrong can delay release, trigger re-testing, or halt supply. This article explains what the QP role involves, why it catches many non-EU companies off guard, and how to set up compliant, efficient QP arrangements without building an in-house European operation from scratch
What Are Qualified Person Services in the EU?
The Qualified Person is a role defined in European pharmaceutical law, including Directive 2001/83/EC, with no direct equivalent in the United States, Japan, or most other regulatory systems. The QP is a named individual accepted by the relevant national competent authority in connection with a manufacturing and/or importation authorisation. The QP has personal legal responsibility for certifying that each batch of a medicinal product has been manufactured and tested in accordance with Good Manufacturing Practice (GMP) and the terms of its marketing authorisation or clinical trial authorisation, as applicable.
The QP’s certification is the final gate before a product reaches patients. If a quality defect emerges after release, regulators can trace accountability directly back to the QP who signed off on that batch. For companies accustomed to the US system — where the Head of Quality fulfils a broadly similar function but without the same personal statutory liability — this level of individual accountability can come as a surprise.
Every holder of an EU manufacturing or importation authorisation (MIA) is legally required to have at least one QP permanently and continuously at its disposal. The QP must meet the statutory education and practical experience requirements set out in EU law, including specified scientific qualifications and experience in GMP-authorised facilities.
Why Non-EU Pharmaceutical Companies Need EU QP Services
If your company is based in the US, India, China, Japan, South Korea, the United Kingdom, Switzerland, or any other country outside the EU/EEA, and you want to sell medicinal products or supply investigational medicinal products (IMPs) in the EU/EEA, your product must pass through an authorised importer that holds a Manufacturing and Importation Authorisation. That importer’s QP is the person who certifies the batch for release to the European market or for clinical-trial supply. Specific arrangements may differ for countries covered by Mutual Recognition Agreements, such as Switzerland.
This creates several practical challenges that non-EU companies frequently underestimate:
GMP equivalence verification. The QP must be satisfied that your manufacturing site operates to standards at least equivalent to EU GMP. For countries without a Mutual Recognition Agreement (MRA) with the EU, this typically means your site must have been inspected and found compliant, and the QP may require independent audit evidence.
The QP Declaration for clinical trials. If you are a US-based sponsor running a clinical trial in the EU/EEA with IMPs manufactured in a third country, you may need a QP Declaration as part of the clinical trial application. Under Regulation (EU) No 536/2014, the declaration confirms that manufacturing complies with GMP standards at least equivalent to EU GMP. There is no equivalent requirement in the US regulatory framework, and many sponsors discover this obligation late in their trial planning.
Testing at import. Unless an MRA or another specific legal basis allows otherwise, medicinal products imported from third countries normally require batch testing or confirmatory testing within the EU/EEA before QP certification. This adds time and cost to your supply chain, and the logistics need to be planned well in advance.
Post-Brexit complications. Since the UK left the EU, companies can no longer assume that UK-based release arrangements provide direct access to the EU/EEA market. Products manufactured or released in the UK and destined for the EU/EEA may require EU/EEA importation, testing where applicable, and QP certification by an authorised EU/EEA importer. Companies that previously used the UK as their gateway to Europe have QP Certification and EU Batch Release: How the Process Works
QP Certification and EU Batch Release: How the Process Works
The detailed requirements for QP certification are set out in Annex 16 of the EU GMP Guide. For imported medicinal products, Annex 21 should also be considered; for IMPs, the Clinical Trials Regulation and applicable investigational-medicinal-product GMP guidance are also relevant. In practice, the QP reviews three categories of documentation before certifying a batch:
Regulatory documents: the marketing authorisation or clinical trial authorisation, the product specification file (for IMPs), study protocols, and any relevant regulatory approvals or variations.
Supply chain records: the QP Declaration (for non-EU sites), quality agreements between all parties in the supply chain, and evidence that each manufacturing and testing site operates to EU GMP standards.
Batch-specific records: manufacturing batch records, in-process control data, finished product analytical results, stability data, deviation reports, and any other documentation relevant to the specific batch under review.
The QP must be satisfied that the batch complies with GMP, with the terms of its authorisation, and that the complete supply chain – however many countries and sites it spans – has been adequately overseen. Only after QP certification can the batch be released for sale or supply, or released for use in the clinical trial, as applicable.
When to Outsource Qualified Person Services
Many non-EU companies do not have an EU-based entity with a manufacturing or importation authorisation, and even those that do may not have a QP with the right experience for every product type – biologics, sterile products, ATMPs, and generics each carry distinct technical considerations.
Outsourcing QP services through an appropriately authorised partner allows you to access EU/EEA batch release capability without establishing or staffing an EU subsidiary for that purpose. The right partner will provide not just access to a named QP, but also the surrounding infrastructure: GMP audit programmes for your manufacturing sites, guidance on documentation standards, support during regulatory inspections, and the regulatory intelligence to keep pace with evolving requirements across EU Member States.
When evaluating QP service providers, it pays to look beyond the signature. Key questions to consider include whether the QP has experience with your specific product type and dosage form; whether the provider has an established network that can support on-site audits in your manufacturing countries; and whether they can scale with your portfolio as you add products or expand into additional EU markets.
How Apotech Supports EU QP Certification and Batch Release
Apotech provides interim, named, and on-demand QP support for both commercial medicinal products and investigational medicinal products. Our senior QPs have experience across a wide range of product types — including biologics, small molecules, generics, and sterile products — and have worked with manufacturing sites across North America, Asia, the Middle East, and beyond.
Because we operate a network of over 800+ consultants spanning 110+ countries, we can pair QP certification with in-country GMP/GDP audits at your manufacturing and distribution sites, removing the need to coordinate multiple suppliers. Our QPs do not work in isolation: they are supported by regulatory affairs specialists, quality assurance consultants, and engineering experts who can address upstream issues before they become batch release blockers.
Whether you are preparing your first EU clinical trial submission and need a QP Declaration, importing a commercial product for the first time, or managing a complex multi-site supply chain, we provide the expertise and flexibility to keep your products moving.
Key takeaways Planning Your EU QP Strategy
The QP requirement is not optional and cannot be delegated to an in-house quality manager unless that individual meets the statutory qualification requirements and is accepted within the relevant authorised framework. Planning your QP arrangements early, ideally during product development and certainly before filing for marketing authorisation or clinical trial authorisation, helps avoid costly delays later. Bear in mind that QP support is usually a long-term need, so it is worth selecting your partner strategically.
For companies based outside the EU, the most efficient path is often to partner with a consultancy that can provide both the QP and the surrounding compliance infrastructure (audits, regulatory support, and quality systems guidance) under a single agreement. This integrated approach reduces coordination risk, shortens time to market, and gives regulators confidence that your supply chain oversight is robust and well-documented