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 ]
