Global Cosmetic Compliance
Intelligence & Solutions

Guideline for Product Information File (PIF)

Local Title
Annex I, part 13 GUIDELINE FOR PRODUCT INFORMATION FILE (PIF)
Country/Region
Malaysia
Competent Authority
National Pharmaceutical Regulatory Agency
Type
Regulation
Status
In force
Release Date
2022-07-19
Implementation Date
2022-08-01

The guideline requires the cosmetic notification holder (CNH) to keep a product information file “readily accessible to the NPRA at the address specified on the label”.

The main objective of this guideline is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. This document also provides guidance on who is responsible to keep the PIF and some guiding points for PIF audits.

Main Content

1. Introduction and objective

2. PIF organisation

3. Who is responsible to keep the PIF

4. PIF Audits

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