Malaysia: Warning Statement for Health Supplement Products Containing Chromium Active Ingredients

ARQon
Jun 28, 2023
1 min read

National Pharmaceutical Regulatory Agency (NPRA) notified all product registration holders (PRH) to act on the addendum of the warning statement for health supplement products containing chromium active ingredients.

This provision was published on 19 June 2023 pursuant to the Regulation 29 of the Pharmaceuticals and Cosmetics Regulations 1984 (PKDK 1984) and will be in full force from 1 July 2023.

PRH must ensure all labeling, packaging, and drug information leaflets for consumers (RiMUP) for health supplement products with active Chromium ingredients include a warning statement as below:

“Warning

Please consult your doctor/pharmacist before using this product. If you are on other medicines, there may be a potential for interactions or side effects.”

The amendment application for the labeling, packaging, and information leaflets must be applied via variation application. The effective date for information updates for new product submissions and products under evaluation is 1 July 2023. Meanwhile, for the existing registered health supplement products, the implementation date is 1 December 2023.

Source: National Pharmaceutical Regulatory Agency (NPRA)