EU GMP Annex 21 - Importation of Medicinal Products

What it says

Medicinal products imported into the EU or EEA must undergo importation activities under the authorisation of an importation licence holder, including physical receipt from a third country and, where required, quality control testing and Qualified Person certification confirming compliance with EU GMP standards equivalent to those applied to domestically manufactured products.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This annex, one of the more recently introduced EU GMP annexes, addresses the specific regulatory gap of products manufactured outside the EU/EEA entering the EU supply chain, requiring importation-specific licensing and oversight distinct from domestic manufacturing authorisation.
• Quality control testing requirements for imported products can be reduced or waived where a Mutual Recognition Agreement exists between the EU and the exporting country's regulatory authority, but only within the specific scope that agreement covers.
• Qualified Person certification obligations extend to imported product, meaning the same personal certification liability described in Annex 16 applies to confirming an imported batch's compliance, not just domestically manufactured batches.

What inspectors look for

• Whether importation activities are conducted under a valid, appropriately scoped importation licence.
• Where Mutual Recognition Agreement provisions are relied upon to reduce testing, whether the specific product and originating country genuinely fall within that agreement's actual scope.
• Whether Qualified Person certification for imported batches reflects genuine review of manufacturing and testing evidence, not an assumption of compliance based on the exporting site's reputation alone.

Related regulations