The EU-GMP Guideline of Annex 21, titled “Importation of Medicinal Products,” provides guidelines for pharmaceutical companies importing drugs into the European Union (EU). This annex sets out the requirements and procedures that companies must follow to ensure the quality, safety, and efficacy of imported medicinal products.

Here are some key points regarding how Annex 21 can affect pharmaceutical companies importing drugs into Europe:

  1. Qualification of the Importer: Annex 21 emphasizes the need for importers to be appropriately qualified, with adequate facilities, personnel, and quality systems in place to ensure compliance with good manufacturing practices (GMP). Companies must demonstrate their ability to meet the necessary standards for importation.
  2. Supply Chain Oversight: The annex places a significant emphasis on the control and oversight of the entire supply chain. Importers are responsible for verifying the compliance of the manufacturing and distribution sites involved in the production and handling of the imported medicinal products.
  3. Quality Management System: Annex 21 requires importers to have a robust quality management system (QMS) in place to ensure compliance with GMP requirements. This includes procedures for product release, handling of deviations, complaints, recalls, and investigations.
  4. Documentation and Record-Keeping: Importers are required to maintain comprehensive documentation and records related to the imported medicinal products. This includes records of the manufacturing and distribution activities, transportation, storage conditions, and any other relevant documentation.
  5. Risk-Based Approach: Annex 21 promotes a risk-based approach to importation. Importers should conduct risk assessments to identify and evaluate potential risks associated with the imported products, including factors such as the geographical location, the reputation of the manufacturer, and the complexity of the product.

MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. we can work with to identify and qualify your EU sites of Importation.

MIAS provides expertise in areas such as quality management systems, risk assessment, documentation, and regulatory compliance. Whether you plan on carrying out a clinical trial or commercialising your product MIAS can develop tailored strategies and procedures to meet the importation requirements and maintain high-quality standards for imported medicinal products.

For more information on how we can help please contact