Part I, Section D : Label (Mock-Up) for Immediate Container, Outer Carton and Proposed Package Insert & PIL

Specific Labelling Requirements:

  • Please refer to Drug Registration Guidance Document (DRGD) Appendix 9: Labelling Requirements 
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).

A document defining information intended for the patien that may be supplied with a pharmaceutical product by the marketing authorization holder

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Tuesday 15 October 2019, 16:40:54.
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