On 23 June 2026 the European Commission published a revised Annex 19 of the EU GMP Guide, as C(2026) 4135 final. It replaces the 2006 version. It comes into operation three months after publication – 24 September 2026.
If you do not re-package parallel imported or parallel distributed product, almost nothing here changes for you. The rules on reference sample size, storage duration, storage conditions, written agreements and manufacturer closedown read as they did before.
If you do re-package, one entire new section applies to you. Part of it requires you to have agreed something with your competent authority before the date. That is the part people will miss, because you cannot fix it afterwards.
Why the Revision Happened
The document says so directly. The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended revising Annex 19 with respect to reference and retention samples for parallel imported, parallel distributed and parallel traded products.
That is the whole reason for the change. It is a narrow, targeted revision, not a rewrite.
Two things follow. First, most manufacturers can read this in ten minutes and move on. Second, the small group it does affect has real work to do, and very little has been written about it.
The legal basis is Article 47 of Directive 2001/83/EC. The Annex interprets the GMP principles laid down in Commission Directive 2017/1572/EU.
What Section 9 Actually Requires
Section 9 is new. Here is what it says, in plain terms.
Keep the packaging materials you used. Physical samples of packaging materials used in re-packaging – labels, cartons, the patient information leaflet, any other package inserts – must be retained for the shelf life of the re-packaged product.
You do not need reference samples of the re-packaged product. Section 9.2 states this plainly. Reference samples exist to be analysed, and re-packaging does not change the product inside.
You do need a retention sample for each re-packaging operation. Not one per batch. One per operation, retained at least one year after expiry date. If a batch goes through two distinct re-packaging operations, that is two retention samples.
The sample must show both packages. It has to represent what actually went to market, including primary and secondary packaging. One relief: if the secondary package is not opened, you only need to retain the packaging material used.
The Part That Has a Deadline Attached
Section 9.5 is the reason this article exists.
Where you can justify that keeping a physical retention sample is not reasonable, you may keep a photographic or digital sample instead. That sounds like a convenience. Read the condition attached to it:
… and this has been agreed in advance with the competent authority.
Agreed in advance. Not notified. Not documented in your file for the next inspection. Agreed, with your competent authority, before you rely on it.
If you intend to use digital samples from 24 September, that conversation needs to be happening now. Competent authorities do not turn these around in a week, and the burden of justification sits with you.
What a Digital Sample Has to Prove
If you go the digital route, Annex 19 sets a high bar. The photographic or digital sample must:
- Be a complete record, with enough information to allow full visual examination
- Permit investigations equivalent to what a physical sample would allow
- Consist of high-quality photos of the re-packaged product
- Be traceable to the batch packaging record for that specific product
- Include all data on both primary and secondary packaging – batch number, expiry date and the rest
- Show evidence that the safety features have been applied
- Allow identification of information in braille
The last two deserve attention, because they are photography problems before they are compliance problems.
Safety features means the tamper-evident seal and the unique identifier. Your images have to show both were applied, which usually means more than one angle.
Braille is harder. Braille is raised dots on a carton, and under flat lighting it can be almost invisible in a photograph. Capturing it so it can be identified takes raking light across the surface and a fixed setup that gives the same result every time. This is not a phone camera on a bench. Someone has to design the photographic method, and someone has to show it works.
Your Photo Files Are Now GMP Records
Section 9.5.4 is one line, and it carries more weight than the rest of the section combined. Any photographic or digital sample stored electronically must comply with the principles of Annex 11 to ensure integrity of the record over the retention period.
That means a folder of JPEGs on a shared drive does not qualify. Annex 11 brings the whole data integrity apparatus with it:
- The system storing the images needs to be validated for its intended use
- Access has to be controlled, with defined user roles
- There has to be an audit trail covering creation, change and deletion
- Backup and restore must be demonstrated, not assumed
- Records must stay readable and retrievable for the full retention period – at least one year past expiry
Read that retention period again with a technology lens. You are committing to keep image files readable for years, on a system you have to keep validated, through operating system changes and file format drift.
For some organisations the honest conclusion will be that keeping a physical carton in a box is cheaper and simpler than running a validated image repository. That is a legitimate outcome, and it is worth reaching it deliberately rather than discovering it in year three.
What To Do Before 24 September
Decide whether Section 9 applies to you. Do you re-package parallel imported, parallel distributed or parallel traded product? If not, document that you assessed it and move on.
If yes, pick physical or digital now. This is a real decision with cost on both sides. Physical means storage space and handling. Digital means a validated system and a photographic method.
If digital, start the competent authority conversation immediately. The agreement must be in place in advance. There is no version of this where you begin in October and backdate the discussion.
Update your sampling procedure. Retention per re-packaging operation, not per batch. Packaging materials held for the shelf life of the re-packaged product. Both are likely to differ from what your current SOP says.
Check the written agreements. Where the MAH, the re-packager and the QP sit in different legal entities, section 6 still requires responsibility for taking and storing samples to be defined in writing. New sampling obligations mean those agreements need reviewing.
Brief your QP. The QP certifying the batch has to be satisfied that relevant samples are accessible at all reasonable times. If sampling arrangements change, that is a QP-relevant change.
Conclusion
This is a narrow revision with a hard date and one genuine trap in it.
The trap is not the sampling rules. Those are readable in a single sitting and mostly a procedure update. The trap is the prior agreement clause in 9.5 combined with the Annex 11 obligation in 9.5.4. Together they mean the digital option is only available to organisations that started early and are willing to run image storage as a validated GMP system.
Everyone else should plan on retaining physical cartons, and should confirm they have the space to do it before September.
Key Takeaways
Effective 24 September 2026. Published 23 June 2026 as C(2026) 4135 final, in operation three months after publication.
The change is narrow. The Inspectors Working Group and PIC/S recommended a revision specific to parallel imported, distributed and traded products.
Retention samples are per re-packaging operation, held at least one year past expiry. Reference samples of re-packaged product are not required.
Digital samples require prior agreement with the competent authority. This cannot be arranged after the fact, which makes it the item with a real deadline.
Digital samples must show safety features and braille. Both need a defined, repeatable photographic method.
Stored images fall under Annex 11. Validation, access control, audit trail, backup and long-term readability all apply. For many, physical retention will be the cheaper answer.
Source: European Commission, EU Guidelines for Good Manufacturing Practice, Annex 19: Reference and Retention Samples, C(2026) 4135 final, Brussels, 23 June 2026.
Related reading: Quality System Design, Standardization & Remediation and Inspection & Audit Management.