Annex 13 governs the manufacture, labelling, QP certification, shipping, blinding, and reconciliation of Investigational Medicinal Products (IMPs) used in clinical trials. It defines the sponsor's GMP obligations, requirements for the product specification file, randomisation/code-break controls, and accountability of returned and unused IMP.

V5 treats IMPs as first-class records: blinded labels, randomisation lists, kit assembly, site shipments, and per-subject reconciliation all flow through eBMR/eDHR with Part 11 controls.

Regulatory anchors

EU GMP Annex 13

Where this term comes up

Pharmaceutical Vet Pharma

How V5 handles it

eBMR / eDHR — the batch record fills in as the work is done.

When operators record their work at the step, the batch record no longer has to be assembled afterwards. People review it and decide release.

21 CFR Part 11 — signatures and audit history your team can validate.

V5 supports electronic signing, audit history and validation evidence. Whether your use meets Part 11 is established by your own validation and procedures.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

Annex 13

Next step

Annex 13

Next step