Throughout the registration validity period of a natural (traditional medicine & homeopathy) and health supplement product, the product registration holder is responsible for the product that is placed in the market and to make any amendments to the registration dossier based on any technical and scientific progress regarding the product. This is required to enable the natural and health supplement products to be manufactured and evaluated by generally accepted scientific methods. Such amendments have to be approved by National Pharmaceutical Control Bureau (NPCB).
This guideline is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a natural and health supplement product of abridged category. It is not applicable for natural and health supplement product of full evaluation category and reference shall be made to Malaysian Variation Guideline for Pharmaceutical Product instead. Variation applications are categorized into Major Variation, Minor Variation (Prior Approval) and Minor Variation (Notification). The guideline covers variation on both drug product (finished product) and drug substance (active ingredient). Updating of this guideline will be done on a periodic basis as required.