Artworks approval by Regulatory


(Ikhlas Yusaf) #1

May I get some information regarding artwork that what parameters are to be checked by regulatory dpt of a firm in approval of product artwork?


(Helen Crowley) #2

Generally everything except the marketing aspect of the labelling (company logo etc) would be approved by the regulatory department. Ensuring the format of the leaflet, labels and carton are in compliance with QRD template (ensure any excipient warnings are included etc).

Ensure the leaflet is in compliance with the SPC from which it is derived.


(dushyant) #3

Check point would be i.e. Band/generic name,composition,Neutral code/ML licence No., ,storage condition, any requirement for targeted market/country specific requirement, any regulatory requirements i.e. schedules warning, red line, other special instruction.

However regarding labeling contains other than composition/label claim ,manufacture/regulatory team can refer concern product’s SPC/labeling contains through concern regulatory literature availability.