Variation Application For Health Supplement And Natural Products

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Variation application for Health Supplement Products and Natural Products shall follow Malaysian Variation Guideline (MVG) For Natural (Traditional Medicine & Homeopathy) And Health Supplement Products (Abridged Evaluation) as stated in the directive issued by Director of Pharmaceutical Services under Regulation 29, CDCR 1984; Directive No. 14 Year 2016. Ref: BPFK/PPP/07/25(45): Direktif Untuk Melaksanakan Malaysian Variation Guideline (MVG) For Natural (Traditional Medicine & Homeopathy) And Health Supplement Products (Abridged Evaluation

Variation refers to change of particulars of a registered product. No change of any particulars of a registered product shall be made without prior approval from NPRA. The registration of a product shall be reviewed for suspension or cancellation if changes are implemented without prior approval of the Authority. 

All supporting documents in accordance to the specified conditions laid down for each type of variation should be submitted. For further information pertaining to conditions and supporting documents required for an application of variation, please refer toMalaysian Variation Guideline (MVG) For Natural (Traditional Medicine & Homeopathy) And Health Supplement Products (Abridged Evaluation).

If deemed necessary, NPRA reserves the right to request for additional supporting documents and variation approval letters from other regulatory bodies for all categories of products.

 

 

MODE OF SUBMISSION

Applicant shall submit the variation application through the current online system.

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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  • Last Modified: Monday 03 December 2018, 16:12:44.
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