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GMP Published

Annex 19 - Reference and Retention Samples

This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the GMP Guide”) gives guidance on the taking and holding of reference samples of starting materials, packaging materials or finished products and retention samples of finished products.

Organisations:
EMA

Version Timeline

Chronological release history

C(2026) 4135 final

Version milestone

Published

Publication Date

23 Jun 2026

Effective Date

23 Jun 2026