Carry a safety wording change through to print
Alerts flags new safety wording that applies to your products. Workbench compares your SmPC and leaflet texts with it, and Print ProofReader checks the printed artwork against the approved text for each market.
One wording change touches every text and pack
A PRAC class wording change has to reach the SmPC, the leaflet and the printed packs in each market. Today someone compares the texts by hand, language by language, then proofs each carton and leaflet against the approved version. EMA's electronic product information (ePI), in FHIR format, starts from the same approved texts.
Store in the original carton.
Store in the original container.
The storage wording has changed from “carton” to “container”. Check it against the approved reference.
From a PRAC wording to a checked pack
Alerts matches the change
Alerts matched PRAC's minutes on sedating antihistamines and OGYEI's request for local confirmation to APAP Noc 500 mg / 25 mg, which contains diphenhydramine.
Workbench compares the texts
Attach the HU and PL SmPCs. Workbench compares section 4.4 in each with the PRAC wording and cites the sentences that are missing or differ, as D1 and D2.
ProofReader checks the print
Once the new text is approved, Print ProofReader compares the carton and leaflet artwork with it for each market and marks missing, added and changed text.
Compare two SmPCs against the PRAC wording
Alerts matched the PRAC minutes to APAP Noc, and Atlas already holds Milan's task to align the HU and PL SmPC section 4.4. Workbench checks both texts before the change is drafted.
What's up next?PRAC wants aligned driving and alcohol wording for sedating antihistamines. Compare section 4.4 in our HU and PL SmPCs for APAP Noc against it. What is missing?
- understanding your question…
APAP Noc 500 mg / 25 mg · HU and PL national · PRAC class wording
- The PRAC wording is a recommendation until it is agreed. Recheck both SmPCs against the final text.
1. Short answer
Both SmPCs carry an alcohol warning in section 4.4, but the PL text uses older wording. Neither has the PRAC driving sentence, which belongs in section 4.7 rather than 4.4.
2. Gaps by text
3. Next steps
- Replace the PL section 4.4 alcohol sentence with the PRAC wording.
- Add the PRAC driving sentence to section 4.7 and leaflet section 2 in both markets.
- Proof the HU and PL cartons and leaflets once the new text is approved.
Each text checked against the wording it must carry
Matched by ingredient
Alerts matched APAP Noc through diphenhydramine, its sedating antihistamine, and lists the HU and PL licences the PRAC wording affects.
Cited sentence by sentence
Workbench quotes the sentence it compared in each SmPC as D1 or D2, next to the PRAC wording it compared it with.
Proofs per market
Print ProofReader compares each market's carton and leaflet with the approved text for that market, and marks missing, added and changed text.
Related on Regunaut
- Read what the new directive requires for electronic product information (ePI).
- New to the term? The glossary explains ePI and its FHIR format.
Take your next wording change to print
See Alerts, Workbench and Print ProofReader on your own products and markets in a 30-minute walkthrough.