6.1

 Maintenance of Registration

• Registration of a product shall be valid for five (5) years or such period as specified in the Authority database (unless the registration is suspended or cancelled by the Authority).
• Application for re-registration (renewal of product 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 product registration holder 3 months prior to the expiry date of a product registration.

6.1.1

Re-registration process

6.1.2

Re-registration processing fees

6.1.3

6.2

 Withdrawal of Product Registration

• The holder of the registered product shall notify the Authority with regards to any decision to withdraw registration of a product and shall state reasons for the decision. The holder shall also notify the Authority when he is no longer authorized to be the holder of the registered product.

6.3

Amendment to the particulars of the product

• Throughout the life cycle of a registered product, changes to improve the product’s efficacy, quality and safety are likely to occur. Therefore, applicant shall inform the Authority pertaining to any changes or amendment made to particulars of a registered product via variation applications.
• An applicant who wishes to apply for any application for imported products of which GMP requirement is a consideration, such as change of manufacturing site and variation, shall comply with the requirement, as stated in directive issued by the Director of Pharmaceutical Services under Regulation 29, CDCR 1984. The Authority shall not consider any application in which the requirement is failed to comply with.

 6.3.1

Variation

6.3.2

Change of Manufacturing Site (COS)

6.3.3

Change of Product Registration Holder  (COH)

6.3.4

 New/Additional Indication (to link to NCE)

6.3.5

 Application for Convenient Pack

6.3.6

 Application of Combo Pack

6.4

 Post Marketing Activities

6.4.1

 Pharmacovigilance

6.4.2

 Post-Market Surveillance

6.4.3

 Punitive Action from the Authority