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Combined SmPCs and PILs

 

Combined SmPCs and PILs/ePILs are allowed, but please make sure they are named correctly to reflect all strengths of the medicine.

If you have two single documents published on emc and you replace one with a combined document, you might need to retire one of the single documents to make sure that information isn’t duplicated on the website.

 

Please be advised 📢

PIL and RMM documents are pre-approved at the point of submission, so once they have passed our QC process, they will go live on the emc website.

SmPC documents are NOT pre-approved. The original submitter will receive an email notification when their document has passed QC and they can then log in to emc publisher to make the final "approve and publish".