EMA: Q&A on QP Certification Without Physical EU Import
The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.
The Agency clarifies that EU legislation does not cover the certification of such batches. Consequently, QPs have no formal role under EU law in certifying these products, and the activity is neither subject to manufacturing or import authorisation nor to inspection by EU competent authorities. References to EU legislation should therefore not be included in related batch release documentation.
Source:
EMA: Guidance on good manufacturing practice and good distribution practice: Questions and answers
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