The application for product renewal (also termed as re-registration of a product) shall only be submitted when all of the requirements for product registration have been complied with. Failure to do so shall result in rejection of the re-registration application by the Authority.
Any form of appeal shall not be considered if the re-registration application is not submitted before the product registration expiry date. A new registration application shall be submitted if the PRH intends to continue the marketing of the product.
It is the responsibility of the PRH to check on the current classification of the product. Re-registration will not be considered for products that have been reclassified from drug to non-drug category (either as medical device or as food product).
Please be reminded that the processing fee for re-registration is non-refundable.
Please refer to National Pharmaceutical Regulatory Agency’s Drug Registration Guidance Document (DRGD) for further information.
