EU packaging & labelling preflight
Find Module 1.3 errors before the member state does.
A structural check over the SmPC, labelling text and package leaflet — against the required particulars, the current QRD template, and the national requirements of every market you declare. Every finding cites the source that generated it.
Included in the Team plan · one run per market · no artwork, translation or legibility assessmentReview shape
Mechanical deficiencies, found mechanically.
Cross-document mismatches between the SmPC, labelling and leaflet are common, embarrassing and entirely checkable. Every finding names the requirement that generated it and the source that backs it.
- Evidence found
- SmPC section 7 and leaflet section 6 give different addresses.
- Source
- Directive 2001/83/EC, Art. 11(7) (SmPC), Art. 54(k) (labelling) and Art. 59(1)(f)(vi) (package leaflet).
- Reviewer action
- Align all three documents on the authorised address.
What it checks
- 01EU-wide
Articles 54, 55, 56a and 59 particulars, QRD template currency, excipients, legal status, FMD safety features, mock-ups and specimens.
- 02Cross-document
Product name, strength, pharmaceutical form and MAH details, stated identically across all three documents.
- 03Per market
Blue box completeness against CMDh/258/2012 Rev.26 for national, MRP and DCP products (the EC Union packaging guideline for centralised ones), Article 63 language coverage and the local representative block — one run for each market you declare, across the 30 EU/EEA states and Northern Ireland, which follows the MHRA's Windsor Framework rules from 2025.
- 04Resilient runs
A market that fails can be retried or skipped without re-running the others, and a partial report names the markets it does not cover.
No account required
Create a packaging scope brief now.
Enter the product and market scope to download a practical brief. This brief is free and needs no account. No files are uploaded, and it does not claim that any product information was assessed — the cited per-market check runs on the Team plan, and your answers carry over when you continue to it.
Free packaging scope brief
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