Generic (Scheduled Poison & Non Scheduled Poison)

Generic Product Registration: Generic Product is defined by NPRA as a product that is essentially similar to a currently registered product in Malaysia. The first company to register a product or a molecule in Malaysia would be given the status of “innovator”. As this company would need to provide documents and supporting clinical trials to NPRA to establish the need of registering the product in Malaysia. Any other registration of the similar product or molecule would be done via the Generic registration route. Generic registration would not have such extensive document requirements for registration as an “innovator” would. However, NPRA still requires sufficient number of documents to establish the product’s quality and efficacy as compared to the “innovator”.

 

 

In Malaysia, a generic product registration is divided to two classes of registration, whereby it is separated by the active ingredient. If the active ingredient is listed in the Poison Act 1952, it would be filed under Generic Scheduled Poison. If the active ingredient is not listed in the Poison Act 1952, it would be filed under Generic Non-Scheduled Poison or also called as Over The Counter Product.

In recent years, NPRA has been imposing many new regulations to regulate the generic registrations in Malaysia. The strategy to obtain a generic product registration in Malaysia is no longer as direct as it used to be. NVS’s consultant is well aware of the latest NPRA requirement and would guide the company to filing the generic product registration in Malaysia and ultimately, obtaining registration.

 

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