Part 1, Section D : Label (Mock-Up) for Immediate Container, Outer Carton and Proposed Package Insert & PIL

Please refer:

- Drug Registration Guidance Document (DRGD) - Appendix 9: Labeling Requirement

Section Attachment/Information

D1

Label (Mock-up) for Immediate Container
Please refer:

Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTON

D2

Label (Mock-up) for Outer Carton
Please refer:

Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTON

D3

Proposed Package Insert
Please refer:
Appendix 9: 9.1.2 PROPOSED PACKAGE INSERT

D4

Patient Information Leaflet (PIL) / RisalahMaklumat Ubat Pesakit (RiMUP)
Please refer:

  1. DirektifPenguatkuasaanKeperluanMengemukakanRisalahMaklumat Ubat untukPengguna (RiMUP) Bil. 5 Year 2011 Bil (15) dlm BPFK/PPP/01/03 Jld 1
  2. Garispanduan Pelaksanaan Risalah Maklumat Ubat untukPengguna (RiMUP)

D5

Label (Mock-up) for Diluent
Please provide label (mock-up) for diluent.

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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