Chapter 1 Malaysia NPRA Regulatory information Brief

1. Eaa and Introduction

The National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health is responsible for market access and review, quality management, post-marketing supervision and regulatory administration of Cosmetics.

2. Supervision and regulation

ASEAN Cosmetic Directive (ACD)

Control of Drugs and Cosmetics Regulation 1984, CDCR

Sale of Drugs Act 1952

3. Cosmetics definition

Cosmetics should mean "any substance or preparation intended to come into contact with various external parts of the human body (epidermis, hair system, nails, lips and external genitalia) or teeth and oral mucous membranes, whose purpose is primarily or exclusively to cleanse, aromatify, improve appearance/improve body odor, protect or maintain good condition."

4. Entry requirement

• ISO 22716 System certificate

• Product details, manufacturer information, finished product quality testing data, finished product stability data, safety assessment data, claim support data, raw material quality data

• CNH details

• Full ingredient list, packaging and labeling

5. Registration language 

English or Malay

6. Cosmetic Notification Holder (CNH) Cosmetic Notification Holder

CNH is the company responsible for bringing cosmetics to market. The CNH must be a local company or legal entity incorporated in Malaysia, specializing in the cosmetics industry, and have a fixed office address. In addition, CNH is also required to be registered with the Companies Commission of Malaysia and its scope of business must cover health or cosmetics related businesses, which should be clearly reflected in the company's Memorandum and articles of Association.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

Registration cycle：Expect 1-3 months.

Registrar's fee：The processing fee for each product of the Cosmetic Notice is RM50.00 and the renewal fee is also RM50.00 per product.

Chapter 3 FAQ 

Q：How long is the validity period of Malaysia Cosmetics notification?

A：The notification for cosmetics is valid for 2 years and should be renewed one month in advance.

Q：Can the product be changed after receiving the Notification number?

A：Agreed. However, if Type2 changes are involved, you will need to resubmit the application, pay a fee, and get a new notification number.