To all marketing authorization holders of Borderline Products

This is to bring to your notice, as there is a failure in the eNMRA digital platform, NMRA has decided to implement the following action plan in a step-by-step manner in order to cater to applicants whose requirements were previously processed through the online system, until the system is restored, in order to continue an uninterrupted services.

Borderline Products Registration Process:

1.Local agent Profile Creation-Suspended temporally until further notice

2.Product Classification (Preliminary evaluation):

New Applications Submission:

• Foreign and Local applications shall be submitted manually as per the documents specified in “Required documents for product classification” under borderline product category
• If the application has already applied through online system it (full application) should be re-submitted manually (hard copies) with the evidence for online submission (at least a document with online submitted classification application reference number)
• If the applicant already paid the payment for the classification process the receipt should be attached to the application (full application) and should submit a confirmation letter stating that the documents which are attached in the manual are same as the in the online submitted application
• Local agent shall submit a consent letter to withdraw the application when the authority notice duplications and decided to withdraw the latest applications as per the reference number (same product submitted by more than one local agent)
• NMRA shall be able to reimburse the processing fee if any application withdraw from the process due to duplications by the NMRA.

Additional Documents Submission:

This is applicable for those who received “Classification Report” through e-NMRA system.

Foreign and Local applications which are having the classification report as “pending decision” &/ or “request additional documents” shall be submitted the initial full application (as per the documents specified in “Required documents for product classification” under borderline product category + copy of payment receipt) manually with the copy of above mentioned classification report ( + manually issued classification reports if available after the online classification report) and requested additional documents.

Applicant should submit a confirmation letter stating that the documents which are attached in the manual application are same as the in the online submitted application.

Note:

• All manual applications will be accepted on Mondays from 9.00 a.m. to 3.30 p.m. only
• The relevant pharmacists in the respective regulatory division would not be held responsible if sequence of any application that had been submitted through eNMRA system breached when implementing the above manual procedure
• New reference number will be given according to the sequence of manual applications submission.

3. Formulation Approval / Sample Import License –Manual Process

4. Registration Dossier Submission (New Applications & Additional Documents Submission)-Manual Process