4.2 : Withdrawal of Product Registration

Kadar pengguna: 3 / 5

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a) The PRH shall submit an official written request to the DCA Secretary if they decide to withdraw the registration of a product before the end of the validity of such registration. The PRH is required to state the reasons for the withdrawal decision in their request. The PRH is also required to inform their manufacturer/ contract manufacturer of their withdrawal decision.


b) The registration of a product, once withdrawn, shall not be reinstated. A new application for product registration is required if the PRH wishes to have the product registered again at a later date.

National Pharmaceutical Regulatory Agency (NPRA)

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