DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)C5 : Recommended Retail Price- Please key in if any (optional)and then click button „Add‟ to save all the entered informations.Note:To add next particulars, repeat the same process until all packings are listedaccordingly. To remove any item from the listing, select item from the listing andclick the “Remove” button.SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTERCARTON AND PROPOSED PACKAGE INSERTThis section is subjected to requirements as stated in Appendix 9: LabellingRequirements and other appendices (where applicable). Please refer theappendices for details.Please attached label (mock-up) i.e. draft of the actual product label andproposed package insert at the following sub-sections:D1. Label (Mock-up) for Immediate ContainerD2. Label (Mock-up) for Outer Carton (Unit Carton)D3. Proposed Package InsertSECTION E/ SECTION F: SUPPLEMENTARY DOCUMENTATION (ANDPARTICULARS OF PRODUCT OWNER, MANUFACTURER, IMPORTER ANDOTHER MANUFACTURER)a) Product OwnerPlease select one of the following for status of product owner:- Manufacturer or- Product registration holder or- Product registration holder & manufacturer or- Others (If the product owner is neither of the above status) – Please entername and address of the product owner.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 451