1) Rationale for the change
Not specified for this version.
GMP
Published
PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Annexes
Version PE 009-18
- Publication
- 23 Sept 2026
- Effective Date
- 24 Sept 2026
- Filename
- pics-pe-009-18-annexes.pdf
- Checksum
- 061e785e317287e7658522d071ad188a480496b1eabea2f48b610ab53d49bbb8
Change Summary
Revised Annex 19, aligning the PIC/S GMP Guide with the EU's revised Annex 19 (C(2026) 4135 final).
Main updates: Annex 19 section 9 — reference and retention samples for parallel imported, parallel distributed and parallel traded products.
Version Change Structure
2) To whom it applies
Not specified for this version.
4) The current change description
Not specified for this version.
Newsletter
Get Guideline Updates in Your Mailbox
Subscribe for major GMP/GDP guideline changes, new publications and timeline updates.