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 an 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. A Qualified Person reviews manufacturing, testing, and supply chain documentation and formally certifies that each batch complies with the Marketing Authorisation and EU GMP standards. Only after this certification can the batch be released for EU market distribution.
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.
The product is imported into the European Union through a site holding a valid Manufacturer Importation Authorisation (MIA). This authorisation permits the licensed entity to receive and manage medicinal products manufactured outside the EU in compliance with EU GMP requirements.
Once imported, the batch undergoes a structured documentation and compliance review. This includes technical compliance checks and verification, ensuring batches are EU importation tested by our Qualified QC Vendors. Manufacturing records, testing results, supply chain verification, and Marketing Authorisation alignment are assessed to confirm the batch meets EU regulatory standards.
A Qualified Person performs the formal certification of the batch in accordance with EU GMP Annex 16. The QP confirms that the product has been manufactured and tested in compliance with EU law and the approved dossier.
After certification, the batch is legally released for distribution within the European Union. At this stage, your product can be placed on the EU market in line with its Marketing Authorisation.
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.
We manage pharmaceutical batch release for medicinal products manufactured outside the EU. This includes structured review of batch documentation, verification against the Marketing Authorisation, and controlled progression toward QP certification. Our focus is regulatory compliance, not administrative processing.
Our GMP batch release process ensures alignment with EU Good Manufacturing Practice requirements. Documentation, testing confirmation, and supply chain integrity are assessed prior to certification. For detailed information on the certification standard applied, see our EU GMP Annex 16 Certification page.
QP release is the formal legal certification of each batch before EU market placement. Our Qualified Persons act in accordance with EU law and carry full responsibility for batch approval. Learn more about this regulatory authority on our Qualified Person (QP) Batch Release Services page.
We operate under a valid Manufacturer Importation Authorisation to permit lawful import of medicinal products into the EU. This is a regulated import function, distinct from certification. Further details are available on our EU Pharmaceutical Importation & MIA Licence page. Each service integrates into one compliant EU market access pathway.
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.
If you hold a Marketing Authorisation outside the EU and manufacture abroad, you must import through an authorised EU entity such as ours and obtain QP certification before release.
Organisations operating asset-light models often rely on external manufacturing partners. We provide the licensed MIA and QP framework required for EU market entry.
Biotech companies scaling from development into commercial supply require structured regulatory oversight for EU distribution. We support that transition.
Manufacturers serving global clients that may require an EU import and certification partner to enable product placement within the EU.
Companies progressing from clinical supply to commercial launch need a compliant import and batch release structure. We provide that regulatory bridge to the EU market.
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.
Importation and QP certification are performed within a system built to withstand regulatory inspection. Documentation control, traceability, and verification processes are established with inspection preparedness in mind.
We operate under a valid Manufacturer Importation Authorisation and apply certification in line with EU GMP Annex 16. This ensures alignment with EU regulatory obligations from import, all the way through to market release.
Each batch undergoes structured technical review before certification. Identifying compliance gaps before QP approval reduces exposure and protects EU supply continuity.
QP certification carries personal legal responsibility. Our Qualified Persons act independently and certify only when EU requirements are met. This level of accountability provides regulatory assurance for EU market placement.
Our team works within EU pharmaceutical law and GMP requirements. We understand the operational and documentation standards expected by competent authorities and structure each batch review accordingly.
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.
EU import and 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 importation through an authorised MIA holder, batch assessment, Qualified Person certification, and final release for EU distribution.
No. Medicinal products manufactured outside the EU must go through a compliant import and batch release process before they can be legally distributed. Without MIA-authorised importation and QP certification under EU GMP Annex 16, products cannot access the EU market.
Yes. EU regulations require both steps as part of a single pathway. Importation under a Manufacturer Importation Authorisation allows the product to enter the EU, while QP certification confirms compliance before market release. One cannot replace the other.
These services are required by non-EU pharmaceutical companies, virtual MAHs, biotech sponsors, and contract manufacturers that produce medicinal products outside the EU but want to supply them within the European market.
Yes. Companies can partner with an authorised MIA holder and QP provider to manage the full import and batch release process. This allows access to the EU market without establishing internal licensed infrastructure.
