CRED 8 Presentations

01/07/2024

Module 1.3.1 SmPC, labelling and Package Leaflet

Product Information (SmPC, labelling text and patient leaflet (PL))

• CP : Product Information is prepared according to EMA QRD template, combined in one document and only provided in English in initial submission.

• MRP/DCP : Product Information is prepared according to CMDh template. Separate SmPC, labelling text and PL can be included

(https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product information/product-information-templates).

The Organisation for Professionals in Regulatory Affairs

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Module 1.3.1 SmPC, labelling and Package Leaflet

Translations In view of the short timeframe for finalisation of the translations highly recommended to prepare for the translation process well in advance in the pre-opinion / position/agreement stage. Local Affiliates/Translation vendors usually prepare initial translations “at risk” and then update as procedure progresses.

CP: start preparing translations after day 120 responses have been submitted and continue at subsequent major milestones (D180 responses). Annex A and INN are required within 5 calendar days of receipt of the CHMP positive opinion.

MRP/DCP depends on procedure timelines and type of MAA (e.g. type of generic application). Would recommend at each major milestone (initial, with D160 response). Annex A and INN are required within 7 days of the end of the procedure

The Organisation for Professionals in Regulatory Affairs

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