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This Malaysian Variation Guideline concerns the variation applications submitted by the PRH for pharmaceutical products for human use only. It is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product.
National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.
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