---
title: "EU GMP: Import of Medicinal Products"
description: "Bringing medicinal products into the EU involves much more than getting them across the border. Discover the GMP requirements, responsibilities and practical considerations behind importing medicines from third countries into the EU. Navigate GMP Annex 21, QP certification, QC testing and the import supply chain with confidence."
url: https://qbdgroup.com/en/downloads/whitepaper-eu-gmp
type: "White paper"
language: en
published: 2025-03-12
category: "Pharma & Biotech"
publisher: "QbD Group"
citation: "QbD Group, \"EU GMP: Import of Medicinal Products\", https://qbdgroup.com/en/downloads/whitepaper-eu-gmp"
---
# EU GMP: Import of Medicinal Products
> Bringing medicinal products into the EU involves much more than getting them across the border. Discover the GMP requirements, responsibilities and practical considerations behind importing medicines from third countries into the EU. Navigate GMP Annex 21, QP certification, QC testing and the import supply chain with confidence.

Bringing medicinal products into the EU involves much more than getting them across the border.

Discover the GMP requirements, responsibilities and practical considerations behind importing medicines from third countries into the EU.

Navigate GMP Annex 21, QP certification, QC testing and the import supply chain with confidence.

## About This White Paper

As pharmaceutical manufacturing becomes increasingly global, more medicinal products intended for the EU market are manufactured outside the EU. At the same time, increasingly complex supply chains have made regulatory oversight of imported products more important than ever.

This white paper provides a practical overview of the requirements for importing medicinal products into the EU. It explains how GMP Annex 21 applies to Manufacturing Import Authorisation (MIA) holders and clarifies the roles and responsibilities of the different parties involved, from the Marketing Authorisation Holder and site of physical importation to the Qualified Person and third-country manufacturer.

You will also learn about QC testing and batch release requirements, Mutual Recognition Agreements, VAT and customs duties, and the practical considerations involved in setting up or outsourcing an EU import site.

## Key Takeaways

✓ **Understand the EU Import Requirements for Medicinal Products.** Learn why importers are classified as manufacturers under EU regulations, why a Manufacturing Import Authorisation is required and which GMP requirements importers need to meet.

✓ **Navigate GMP Annex 21.** Discover how Annex 21 applies to the import of human, veterinary and investigational medicinal products from outside the EU/EEA, and what is considered an "import" under the guidance.

✓ **Know When EU Batch Testing Is Required.** Understand the requirements for testing imported batches before QP certification and release when no Mutual Recognition Agreement is in place.

✓ **Clarify Responsibilities Across the Supply Chain.** Get a clearer view of the respective responsibilities of the Marketing Authorisation Holder, physical import site, QC testing laboratory, QP certification site and third-country manufacturer.

✓ **Understand the Critical Role of the Qualified Person.** Learn how the QP helps ensure each imported batch complies with EU GMP requirements, from reviewing complete batch documentation and QC testing to certification before release onto the EU market.

✓ **Prepare Third-Country Manufacturing Sites for EU GMP.** Explore the expectations around facilities, equipment, training, documentation, supplier controls, stability studies, packaging, labelling and data integrity, and why preparation and mock inspections can be important before an official EU inspection.

✓ **Factor In VAT and Customs Duties.** Understand how VAT rules, customs duties, product classification and country of origin can add another layer of complexity to importing medicinal products into the EU.

✓ **Consider Whether to Build or Outsource Your EU Import Setup.** Discover the infrastructure, expertise and regulatory requirements involved in establishing an EU import site with QP and GMP accreditation, and how outsourcing can provide access to QC, QP and Regulatory Affairs expertise without building the full setup internally.
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Source: https://qbdgroup.com/en/downloads/whitepaper-eu-gmp — © QbD Group. Quote freely with attribution and a link back.