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.
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
- Exact official-source section required.
- 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, Article 63 language coverage, and the local representative block — one run for each of the 31 EU/EEA territories you declare, Northern Ireland included.
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