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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

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Isnin 30 Disember 2024, 16:47:14.

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