Submission Of Bioequvalence (BE) Study Reports For Registered Generic Products In The Form Of Effervescent, Dispersible, Orodispersible, Sublingual, Buccal And Chewable Tablets/Capsules For The Purpose Of Re-Registration (Renewal)

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 Kindly take note that BE study reports for re-registration purposes should ONLY be submitted to NPRA within six (6) to twelve (12) months prior to the expiry of the validity period of the product registration. This is to align the work processes, as well as to ensure that the BE study report evaluation reviews are in line with the re-registration process of generic products.

 

[Directive –Bil (27) dlm BPFK/PPP/07/25]
[Directive –Bil (45) dlm BPFK/PPP/01/03]

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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