Registration of a product shall be valid for five (5) years or such period as specified by the Authority (unless suspended or cancelled by the Authority).
Application for renewal of product registration (also termed as re-registration of a product) shall be submitted within six (6) months prior to the expiry of the validity period of a product registration.
A letter of reminder for product re-registration will be issued to the PRH within 3 months prior to the product registration expiry date.
After the product registration expiry date, the status of product registration shall be automatically changed to ‘expired’, and the PRH will not be able to submit the application for product re-registration.
Any form of appeal shall not be considered if the re-registration application is not submitted before the product registration expiry date as the reminder letter has been issued within 3 months prior to the expiry date. A new registration application shall be submitted if the PRH intends to continue the marketing of the product.
The application for product re-registration shall only be submitted when all of the requirements for product re-registration have been complied with. Failure to do so shall result in rejection of the re-registration application by the Authority.
The requirements for product re-registration as aforementioned are as follow:
- Patient dispensing pack size for pharmaceutical product with tablet/capsule dosage form, including oral liquid preparation and dermatological preparationPlease refer Appendix 10: Guideline on Patient Dispensing Pack for Pharmaceutical
- Bioequivalence study report for all registered generic products containing scheduled poison with immediate release, oral, solid dosage form (came into force starting from 1st January 2013)
- Bioequivalence study report for all registered generic products containing scheduled poison with effervescent, dispersible, orodispersible, sublingual, buccal and chewable dosage form (comes into force for product registration which is expiring starting from 1st January 2019)
- Long term stability study report under the Zone IVb conditions (30°C ± 2°C /75% RH ± 5% RH) for pharmaceutical products containing scheduled poison and non-scheduled poison (but excluding cold chain product) which were submitted for registration before the year 2009, unless exempted by the Authority. (came into force starting from 1st January 2016)
- Valid GMP document/certificate for imported product (came into force starting from 1st January 2014)
To maintain the registration of an imported product, applicant shall comply with GMP requirement as stated in the circular; or directive issued by the Director of Pharmaceutical Services under Regulation 29, CDCR 1984.
Please refer also Annex 1 of Guidance Document for Foreign Inspection.
- Amendment of product name consisting only generic name for registered pharmaceutical product containing scheduled poison and non-scheduled poison (came into force starting from 1st January 2017)
- Endorsement letter of ancillary medical device component (from Medical Device Authority, Malaysia) for re-registration of drug-medical device combination product (comes into force for product registration which is expiring starting from 1st July 2018)
- Regulatory control of active pharmaceutical ingredient (API) for all dosage form of registered pharmaceutical products containing scheduled poison (comes into force for product registration which is expiring starting from 1st January 2020)
- API information shall be submitted at least one year prior to the product registration expiry date.
- Please refer also Appendix 6: Guideline on Regulatory Control of Active Pharmaceutical Ingredients.
APPLICATION FOR PRODUCT RE-REGISTRATION
- The application for product re-registration shall be submitted and paid via QUEST3+ online system.
- The non-refundable processing fee for product re-registration is as follows:
- Natural Product : RM 500.00 per product
- Other than natural product : RM 1,000.00 per product