Frequently Asked Questions (FAQs) on Drug-Medical Device Combination Products

VARIATION ON ANCILLARY COMPONENT

1. Is it a requirement to submit application for endorsement letter when a change occurs to a particular ancillary component?

Yes. This is in line with the requirements stated in Section 6.2 : Changes/Variation To Particulars Of A Registered Medical Device-Drug Combination Product, Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products.

2. Variation procedure for a registered combination product.
3. What is the validity period of the endorsement letter issued for variation of a particular ancillary component ?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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