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

Specific 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 (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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