Section D Veterinary Medicines

Please refer

SECTION 2: GUIDE ON HOW TO FILL THE ON-LINE APPLICATION FORM FOR A NEW PRODUCT REGISTRATION ,STEP 2 : NEW REGISTRATION APPLICATION FORM , SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER CARTON AND PROPOSED PACKAGE INSERT, Registration Guideline of Veterinary Products (REGOVP)

Specific Labelling Requirements

Please refer to Table 1: List of Substances Which Requires Specific Labelling Requirements and Table 2: Details of Specific Labelling Requirements, Registration Guideline of Veterinary Products (REGOVP).

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

Not yet rated