Malaysian business licence·Federal

Registered Manufacturer Licence (RML)

Issued by Ministry of HealthDangerous Drugs Act 1952; Control of Drugs and Cosmetics Regulations 1984

Overview

The Registered Manufacturer Licence (RML) is issued to premises for the manufacturing of registered products and allows for wholesale distribution or supply of those products. It is required for businesses involved in the production and sale of regulated goods.

Key details

Governing Act
Dangerous Drugs Act 1952; Control of Drugs and Cosmetics Regulations 1984
Agency fees
RM 1,000 processing + RM 0 annual
Validity
1 year (renewable annually)
Issuing authority
Ministry of Health

Fees shown are government / local-authority fees payable to the issuing agency. Emerhub charges a separate service fee for handling the application end-to-end.

Eligible applicants

Businesses, companies, limited liability partnerships, professional bodies, cooperatives, others

Application requirements

- Refer to the Guidelines for Application for Registered Manufacturer Licence, Import Licence, and Wholesale Licence issued by the National Pharmaceutical Regulatory Agency (NPRA). - Downloadable from the official NPRA portal.

Agency fee breakdown

Processing fee: RM1,000.00 / application Validity period: One (1) year (Licence expires on December 31 each year)

These are amounts payable to Ministry of Health. Emerhub's service fee is quoted separately when you engage us.