It’s actually real now!

After years of planning, building, auditing, documenting, reviewing, and waiting, we finally have something tangible in our hands: a medicine pack listing Orion GXP as the Manufacturer (Importer) for a product about to be released onto the European market. Seeing our name and address printed on the pack is a milestone that has us all immensely proud at Orion GXP Consulting. It represents not just a regulatory achievement, but the acceptance of responsibility that comes with being named on an EU Manufacturer’s/Importation Authorisation (MIA).

For those of us who live and breathe EU GMP and GDP, that line of text on a pack carries enormous meaning. It signals that we are not just a service provider somewhere in the supply chain. In the eyes of European regulators and competent authorities, we are now the European manufacturer responsible for ensuring that the product being placed on the market meets all applicable requirements for quality, safety, and compliance.
This post is a celebration, but it’s also a reflection on what that responsibility truly means.

The Inspection team posing outside the W8 Centre in Manorhamilton after our successful inspection.

The significance of being named on the pack

In Europe, no medicinal product can be released for sale or supply without certification by a Qualified Person (QP) who is named on a valid MIA. That certification is the final legal step confirming that each batch has been manufactured and checked in accordance with EU law and Good Manufacturing Practice (GMP).

Being listed as Manufacturer (Importer) on a medicine pack means the company holds (or operates under) an MIA and is responsible for the importation and/or batch certification of that product for the EU market. It also means that competent authorities recognise that entity as the European manufacturing site responsible for the release of the product. In other words, if something goes wrong, regulators don’t look first at the site overseas where the product was physically made. They look to the European MIA holder whose QP certified the batch and allowed it onto the EU market.

That’s why seeing our name on the pack feels so significant. It’s the moment when all the systems, procedures, and quality frameworks we’ve built move from theory into reality.

The role of the MIA holder

An MIA (Manufacturer’s/Importation Authorisation) is granted by a European competent authority and allows the holder to perform defined manufacturing or importation activities for medicinal products. For imported products, the MIA holder responsible for batch certification must ensure that the site of physical importation is appropriately authorised and that suitable technical agreements are in place across the supply chain. This framework ensures that responsibility is clearly defined. While physical manufacturing may occur outside the EU, the MIA holder performing batch certification is the entity that stands behind the product from a European regulatory perspective.

That responsibility includes:

- Ensuring that manufacturing and testing have been carried out in compliance with EU GMP (or equivalent standards for third-country manufacture).
- Confirming that the product meets its marketing authorisation and specification.
- Verifying that the entire supply chain meets regulatory requirements.
- Certifying each batch before it is released for sale or supply.

As many QP service providers emphasise, the MIA and QP framework is designed to ensure that every batch of medicine reaching EU patients has undergone a rigorous, accountable release process. When a company is named as the Manufacturer (Importer) on a pack, it is effectively saying: we have taken responsibility for that process.

The Orion Consulting HQ and GMP Centre of Excellence in Manorhamilton.

Importation and batch certification: more than a final check

Importation and batch certification are sometimes misunderstood as administrative steps at the end of the supply chain. In reality, they require deep involvement across the entire lifecycle of the product.

A QP cannot certify a batch without understanding:

- The manufacturing process and controls
- Analytical testing and validation
- The stability profile of the product
- The Quality Management Systems at each site
- Supply chain integrity
- Compliance with the marketing authorisation

This often involves extensive audits, technical agreements, and ongoing oversight. The QP must be satisfied that the product was manufactured and tested according to EU GMP and that the data supporting release are complete and reliable.
For imported products, EU legislation requires that each production batch manufactured in a third country be checked to ensure it meets standards at least equivalent to EU GMP before certification.
In practice, this means the MIA holder and QP become deeply integrated into the supply chain. They are not just reviewing paperwork at the end; they are overseeing the quality framework that supports the product from manufacture through to market.

How competent authorities see the MIA holder

From a regulatory perspective, the MIA holder performing batch certification is the European manufacturer responsible for the product’s release. The competent authority that granted the MIA will inspect and oversee the site, and the QP named on the licence will be legally responsible for certification decisions. Only sites authorised for manufacturing or importation are required to have a QP and can perform batch certification. That legal structure ensures accountability for products placed on the EU market. 
Even when multiple parties are involved—contract manufacturers, testing labs, logistics providers—the ultimate responsibility for batch release remains with the QP and the MIA holder performing certification. 
That’s why being named on the pack matters. It signals to regulators, partners, and patients that the MIA holder stands behind the product. It also means that any inspections, deviations, or quality issues will involve that site directly.

The Orion Manufacturers and Importers Authorisation (MIA).

A shared achievement

While the MIA holder carries legal responsibility for batch certification, the reality is that successful product release is always a collaborative effort. Manufacturing partners, analytical laboratories, logistics providers, regulatory teams, and quality professionals across the supply chain all contribute to ensuring that a product meets EU requirements. The MIA holder and QP act as the final checkpoint, but they rely on the integrity and competence of the entire network.
That’s why this milestone is not only an achievement for Orion but also a shared achievement. Every audit completed, every technical agreement negotiated, every quality review performed has led to this moment.

Looking ahead

Seeing our name on a medicine pack for the first time is a milestone worth celebrating—but it’s also just the beginning.
Being named as Manufacturer (Importer) on an EU product means stepping fully into the role of European manufacturer in the eyes of regulators. It means maintaining the systems and oversight that support batch certification. And it means continuing to uphold the standards that protect patients and ensure product quality. As more products move through our MIA framework and onto the EU market, we remain focused on the responsibilities that come with that role. The regulatory landscape continues to evolve, and so must we—strengthening quality systems, refining processes, and maintaining readiness for inspection and audit.

A moment to pause and appreciate

For now, though, we’re allowing ourselves a moment to appreciate what this represents.

A small line of text on a medicine pack might not look like much. But for those who understand the regulatory framework behind it, it’s a powerful statement of trust and accountability.

It’s actually real now.

Non-EU manufacturers looking to access the European market can partner with Orion GXP Consulting to use our MIA for EU importation and Qualified Person batch certification, providing a compliant, accountable route to release their products across the EU. To discuss how we can support your market entry, contact us on +353 71 981 0101 or email admin@oriongxp.com