--- title: "GMP Annex 21: key requirements for importing medicines into the EU" description: "Learn the key requirements of GMP Annex 21 for importing medicines into the EU, including MIA compliance, QP certification, and supply chain duties." url: https://qbdgroup.com/en/blog/new-gmp-annex-21-importation-of-medicinal-products type: "Blog post" language: en published: 2025-04-16 author: "Yves Peeraer" category: "Lab Services" publisher: "QbD Group" citation: "QbD Group, \"GMP Annex 21: key requirements for importing medicines into the EU\", https://qbdgroup.com/en/blog/new-gmp-annex-21-importation-of-medicinal-products" --- # GMP Annex 21: key requirements for importing medicines into the EU > Learn the key requirements of GMP Annex 21 for importing medicines into the EU, including MIA compliance, QP certification, and supply chain duties. In recent years, **medicinal products** for the EU market have been increasingly manufactured outside the EU. While this trend is particularly noticeable in the production of **active ingredients**, it is also becoming more prevalent in the manufacture of **finished medicinal products**. At the same time, **globalization** has made **pharmaceutical supply chains more complex**. To ensure oversight, the EU classifies medicine importers as manufacturers, requiring them to obtain a Manufacturing Import Authorization (MIA) and comply with Good Manufacturing Practice (GMP) regulations. This framework mandates the implementation of a **pharmaceutical quality system**, adequate staffing and facilities, complaint and recall management, and strict supply chain control. In this guide, we will explore the key aspects of **GMP Annex 21**, its implications for medicine importers, and best practices to ensure compliance. ## GMP Annex 21: overview GMP Annex 21 establishes **GMP requirements for MIA holders** importing medicinal products from outside the **EU/EEA**. The annex applies to: - **medicinal products for human use** - **medicinal products for veterinary use** - **investigational medicinal products** However, it does not cover **products without an EU/EEA marketing authorization** that are directly re-exported. ## Defining 'import' under GMP Annex 21 The Annex provides a common interpretation of import, defining it as the **physical introduction** of a medicinal product from outside the **EU/EEA**. Importation is a regulated process, and **batch release by a Qualified Person (QP)** can only take place _after_ physical importation and **customs clearance** within an **EU/EEA state**. ## Key sites in the importation process GMP Annex 21 highlights two critical sites involved in the **importation of medicinal products**: 1. **Site of physical import** – The location where the medicinal product first enters the EU. 2. **Site of QP certification** – Where a **Qualified Person (QP)** performs batch certification before release. These sites must be considered in the broader context of the **entire supply chain**, which also involves: - **API manufacturers** - **Third-country medicinal product manufacturers** - **Transport companies** - **QC testing facilities for imported products** - **Marketing Authorization Holders (MAH)** ## EU GMP - Import of Medicinal Products ## Compliance requirements for importers For medicinal products imported from countries **without a Mutual Recognition Agreement (MRA)**, **EU law mandates batch testing upon importation** before **QP certification** and release in accordance with **GMP Annex 16**. The **location of testing** and **minimum testing requirements** are outlined in: - **Article 51(1)(b) of Directive 2001/83/EC** (for medicinal products for human use) - **Article 55(1)(b) of Directive 2001/82/EC** (for veterinary medicines) ## Reference to Eudralex guidance GMP Annex 21 references other **Eudralex** chapters and annexes, particularly **Annex 16**, which already defines the responsibilities of a **Qualified Person (QP)** for **batch certification and release**. However, **Annex 21 further emphasizes the role of the Marketing Authorization Holder (MAH)** in ensuring GMP compliance throughout the importation and manufacturing process. For example: - The **MAH must ensure that QPs have full access to batch documentation** at all times. - The **MAH holds ultimate responsibility** for the marketing of medicinal products and must have written agreements in place with all relevant sites. ## Product Quality Review (PQR) in importation Annex 21 also clarifies **Product Quality Review (PQR) requirements** for imported products. The certifying QP must: - compare **analytical results from the import test site** with the **certificate of analysis from the third-country manufacturer**. - Ensure an **ongoing stability program** is in place, even if testing occurs in a third country, as long as the QP has access to stability data. ![Lab services - EU GMP import image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/blog-images/blog_posts/content/new-gmp-annex-21-importation-of-medicinal-products/Lab_services_-_EU_GMP_import_image.png) ## Conclusion As pharmaceutical manufacturing and supply chains continue to globalize, **GMP Annex 21** plays a crucial role in ensuring regulatory oversight of imported medicinal products. The annex strengthens the framework for **MIA holders**, emphasizing **QP responsibilities, supply chain integrity, and rigorous quality control**. Companies involved in importing medicines into the EU must stay ahead of **compliance requirements**, ensure robust documentation, and establish **strong collaborations across the supply chain**. At QbD Group, we provide comprehensive services for companies importing medicines into the EU. Our GMP-certified laboratory and Qualified Person (QP) services ensure seamless **batch release, regulatory compliance, and efficient importation processes**. **Let’s simplify your EU market access.** [**Contact our experts today.**](https://qbdgroup.com/en/contact) ## Need reliable lab testing and validation? ## Ready for reliable results? --- Source: https://qbdgroup.com/en/blog/new-gmp-annex-21-importation-of-medicinal-products — © QbD Group. Quote freely with attribution and a link back.