A new version of EU GMP Annex 19 has been released, replacing the previous version that had been in force since 2006. The updated annex introduces targeted changes, with the most significant ones appearing in Section 9 (parallel-imported, parallel-distributed, and parallel-traded products). The list below presents these changes introduced in the updated version, namely:

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1. Digital retention samples are permitted when a photographic or digital record is justified and agreed with the competent authority.

2. Retention‑sample obligations explicitly apply to all parallel‑imported, parallel‑distributed and parallel‑traded products.

3. Physical samples of all packaging materials used in the repackaging process must be keptretained.

4. Reference samples of the repackaged product are not required.

5. A retention sample of the repackaged finished product must be taken for each repackaging operation.
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This represents a notable shift from the 2006 version, which did not permit digital samples and required physical samples in all circumstances.  

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Beyond this targeted updates, this revision maintains the overall framework governing reference and retention samples. Since the guideline takes effect three months after its publication, it will apply from September 2026. This transition period provides organisations sufficient time to review their operations and implement any necessary adjustments.

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