Entering the European market requires more than logistics. It requires legal importation under a valid Manufacturer Importation Authorisation (MIA), formal batch certification by a Qualified Person (QP) under EU GMP Annex 16, and controlled release for EU distribution.
At Inglasia, we provide fully compliant EU Import & Batch Release services through Ireland, acting as your authorised regulatory partner for both importation and QP certification. We manage the complete pathway: import under MIA, technical batch assessment, Annex 16 QP certification, and final release to the EU market.
If you need a compliant structure to place medicinal products on the EU market, we provide the regulatory framework, licensed infrastructure, and QP authority required under EU law.
Speak to our team about your EU Import & Batch Release strategy now
EU Import & Batch Release is the regulated process that allows medicinal products manufactured outside the European Union to be legally placed on the EU market. It combines two distinct legal functions: importation under a Manufacturer Importation Authorisation (MIA) license and certification by a Qualified Person (QP) in accordance with EU GMP Annex 16.
Import under a Manufacturer Importation Authorisation (MIA) permits the physical entry of your medicinal products into the EU through a licensed entity such as ours.” This authorisation confirms that the site is approved to receive, verify, and manage imported batches in line with EU GMP requirements.
“On the other hand, the QP certification is a separate legal obligation. Our Qualified Person (QP) Batch Release Services ensure each medicinal product batch is reviewed and certified in accordance with EU GMP requirements before release to the European market.
The EU market release is the final outcome of this combined process.
This service is not regulatory consultancy.
It is not warehousing, logistics, or distribution.
It is not a standalone QP signature service without authorised import infrastructure.
We provide a complete legal pathway for compliant EU market access.
Our EU Import & Batch Release process follows a defined regulatory sequence. Each step is required before a medicinal product can enter the EU market.
Our dedicated facility in Ireland provides a recognised and stable regulatory environment for accessing the European Union pharmaceutical market. Operating within an EU Member State ensures that importation and batch certification are conducted under EU law, allowing your medicinal products to move freely across the European Economic Area once released.
Through Ireland, Inglasia delivers full MIA importation and Qualified Person certification within a single authorised structure. Our Manufacturer Importation Authorisation permits lawful entry of your medicinal products into the EU. The appointed QP then performs certification in accordance with EU GMP requirements before market release.
This framework provides you with direct access to the EU regulatory system without the need to establish your own licensed importation entity in Europe. It also ensures alignment with European Medicines Agency standards and national competent authority oversight.
Our single partner model means that the importation, compliance oversight, and QP batch certification are managed within one coordinated pathway. You avoid fragmented providers, duplicated processes, and regulatory gaps.
For companies outside the EU, our facility in Ireland offers a clear and compliant route to EU market entry through a fully authorised regulatory structure.
Our EU Import & Batch Release services are designed for companies that require a compliant pathway to place medicinal products on the European market without establishing their own EU importation infrastructure.
EU batch release is a legal responsibility, not an administrative task. Most companies choose Inglasia because we operate within a fully authorised regulatory structure designed for compliance, oversight, and controlled EU market access.
EU Import & Batch Release operates within a defined European regulatory structure. Every stage of the process aligns with EU Good Manufacturing Practice (EU GMP) requirements and the legal obligations governing medicinal product importation and certification.
Our import activities are conducted under a valid Manufacturer Importation Authorisation (MIA), which permits lawful entry of medicinal products into the European Union. This authorisation confirms that our importing facility meets EU standards for quality systems, oversight, and control.
Batch certification is performed in accordance with EU GMP Annex 16. This framework defines the responsibilities of the Qualified Person and sets the conditions under which a batch may be certified for release to the EU market.
The broader regulatory environment is shaped by the European Medicines Agency framework and national competent authorities, which oversee compliance, inspection, and enforcement.
Our service is built around these regulatory requirements.
It is structured to meet EU law from import through to certified market release.
Inglasia is your trusted partner for full EU Import & Batch Release services. We combine MIA-authorised importation, Annex 16 QP certification, and controlled EU market release within a single, compliant pathway.
Whether you are a non-EU MAH, biotech sponsor, or contract manufacturer, our team provides the regulatory oversight, legal authority, and the operational control necessary to place medicinal products on the European market confidently and efficiently.
Ensure your batches meet EU GMP requirements, pass inspections, and are released under the responsibility of a qualified person. Don’t risk delays or compliance gaps—partner with us and we’ll manage the complete regulatory pathway.
Contact us today to discuss your EU import and batch release requirements or schedule a consultation with our regulatory specialists.
Let Inglasia handle the legal, technical, and compliance responsibilities so you can focus on your business.
