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

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):
Drug Registration Guidance Document (DRGD) - Appendix 9: Labelling 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 (mockup) for diluent.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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