Is QP Certification required when Products do not enter EU Territory?
Recommendation
11/12 March 2026
Hamburg, Germany
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The European Medicines Agency (EMA) has published a new Q&A addressing the requirement for Qualified Person (QP) certification of batches that are neither manufactured in the EU/EEA nor intended for the EU/EEA market and are not physically imported into the EU/EEA.
In such cases, QP certification does not fall under EU legislation. This would only apply if the medicinal products were intended for the EU market or were to be used in clinical trials within the EU/EEA.. Consequently, these activities are not subject to authorisation under a manufacturing or import authorisation, nor are they subject to inspection by EU National Competent Authorities.
Accordingly, references to EU legislation should not be included in documentation related to the batch release of medicinal product batches that are not manufactured in the EU/EEA, not intended for supply to EU/EEA countries, and not physically imported into the EU/EEA.
The Q&A can be found in the section on Annex 16 on the Agency website.
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