Throughout the life of a pharmaceutical product, the marketing authorization holder is responsible for the product that is placed in the market and is also required to take into account technical and scientific progress, and to make any amendments that may be required to enable the pharmaceutical products to be manufactured and checked by means of generally accepted scientific methods. Such amendments have to be approved by the Drug Regulatory Authority.

This guidance document is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product. Variation applications are categorized into major variation, minor variation (prior approval) and minor variation (notification). Updating of this guideline will be done on a periodic basis as required.

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