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
Document
Language Source Title Access
EN
Official Annex I, Part 13 Guideline for Product Information File (PIF)
Summary

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

History
2022-07-19
Guideline for Product Information File (PIF)
In force
Release Date: 2022-07-19
Implementation Date : 2022-08-01
2017-02-01
Invalid
Release Date: 2017-02-01
Implementation Date : 2017-02-01
Noteworthy Information