Submission of RiMUP for Evaluation by the Pharmacovigilance Section, PKKK

As of April 2025, all RiMUP for evaluation by the Pharmacovigilance Section (previously requiring manual submission) should be submitted through the QUEST 3+ system.

Please note: There is no change to the existing procedure for all products registered after 1 January 2014, whereby the RiMUPs are evaluated by the Centre of Product and Cosmetic Evaluation (PPPK).

Refer to the updated guidelines for specific details on the products involved [Garis Panduan Pelaksanaan RiMUP – Section 2: Table ].

Variation label:

Only RiMUPs for evaluation by the Pharmacovigilance Section should be submitted using the following new variation labels:

• MiV-PA3(PV): For pharmaceutical or biologic products
• MiV-PA2(PV): For natural products with therapeutic claims, and health supplements with disease risk reduction claims

Once a RiMUP has been submitted for evaluation by the Pharmacovigilance Section, kindly send an email to inform our team [ rimup@npra.gov.my ]