PIC/S Revises GMP Guide Annex 19 on Reference and Retention Samples
PIC/S revised its GMP Guide for Medicinal Products to version PE 009-18, incorporating the revised Annex 19 on reference and retention samples. The revision primarily concerns Section 9, addressing samples for parallel imported, parallel distributed, and parallel traded products. A note specifying that Section 9 applies only where these activities are covered by local legislation has been retained. The PIC/S Committee adopted the revision by written procedure on 22 September 2026. PE 009-18 enters into force on 24 September 2026, coinciding with the revised EU Annex 19. Non-EEA PIC/S Participating Authorities and Applicants have been invited to transpose Annex 19 into their GMP Guides.