Section

Attachment/Information

D1

Label (Mock-up) for Immediate Container

D2

Label (Mock-up) for Outer Carton

D3

Proposed Package Insert

D4

Patient Information Leaflet (PIL) (Optional)

• Please refer to SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER CARTON AND PROPOSED PACKAGE INSERT (Product Information Leaflet), Registration Guideline of Veterinary Products (REGOVP).
• A document defining information intended for the patient that may be supplied with a pharmaceutical product by the marketing authorization holder