What happened
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.
Why it matters
From a GMP and pharmaceutical manufacturing perspective, the revision may require organizations operating under implementing authorities to review arrangements for reference and retention samples. Particular attention may be warranted for parallel imported, distributed, or traded products where local legislation covers those activities. The coordinated PIC/S and EU effective date supports harmonised GMP standards, while implementation outside the EEA depends on transposition by relevant PIC/S authorities or applicants.
Key topics: Revised PIC/S Annex 19, Reference and retention samples, Parallel imported, distributed, and traded products
Source: Pharmaceutical Inspection Co-operation Scheme (PIC/S)