All Marketing Authorization Holders (MAHs) of Borderline Products are hereby informed that the Borderline Products Regulatory Division has decided to:

1. Accept transferred applications that have already been submitted to the Medicines Regulatory Division, whether as new applications, re -registrations, or renewals. The remaining balance for the Borderline Products new registration fee should be paid to proceed with the application.

2. Accept transferred applications that have already been submitted to the Medical Devices Regulatory Division:

• For new applications, payment is not required since the new application fee for Medical Devices is same as the Borderline Products new application fee
• For renewal applications, the remaining for the Borderline Products new registration fee balance should be paid to proceed with the application.

3. Accept transferred applications that have already been submitted as cosmetic products, whether as new applications or renewals. Borderline Products new registration fee should be paid to proceed with the application.

Furthermore, the NMRA has decieded to waive off the process of sample licensing and classification for such transferred applications.

Please contact the Borderline Products Regulatory Division to clarify whether a new dossier should be submitted with the payment. Applications referred from the cosmitcs division must be submitted with a new dossier.

( Date: 31 May 2024)