EMA Clarifies QP Certification Rules for Non-EU/EEA Medicinal Product Batches

The European Medicines Agency (EMA) has published a new Q&A clarifying the requirement for Qualified Person (QP) certification for medicinal product batches that are neither manufactured in the EU/EEA nor intended for the EU/EEA market and are not physically imported into the region.

According to the EMA, QP certification in such cases does not fall under EU legislation. EU requirements would only apply if the products were destined for the EU/EEA market or intended for use in clinical trials conducted within the EU/EEA. As a result, these activities do not require a manufacturing or import authorisation and are not subject to inspection by EU National Competent Authorities.

The agency further stated that references to EU legislation should not be included in batch release documentation for products manufactured and supplied entirely outside the EU/EEA.

The clarification is available in the Q&A section related to Annex 16 on the EMA website.

09-01-2026