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Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity

Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products" that provides information to the industry regarding license requirements to carry out activities related to manufacturing, importation, and supply or wholesale of products registered with the Drug Control Authority (DCA), Ministry of Health Malaysia (MOH).

This guideline also explains the procedures for applications for Manufacturer’s License, Import License and Wholesaler’s License for registered products and the license application shall be submitted via the QUEST System.


As per the guidance, the license issued shall be valid for 1 year or until 31 December of the same year or such period as specified in the license and Every license issued shall not be exchangeable or transferable to another person or company.


Click this LINK to know more about the Licensing requirements, etc.


The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia recently (07 July, 2023) published a guideline on controlling nitrosamine impurities in pharmaceutical products. To meet the demands, product registration holders may submit files created to qualify the needs of Europe and the United States.


All products that are found to contain impurities derived from nitrosamine are going to be included in the scope of the guidance. As part of the guidance, registration holders are advised of risk factors related to the manufacture of APIs, finished products, and good manufacturing practices.


A frequently asked question (FAQ) document is attached to the guideline, explaining that no deadline has been set for the work and that risk assessments are the responsibility of registration holders.



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