1. The valid period of Classification Report is one year and the valid period is counted from approval date of the Classification Report ("Classified as a Borderline Product").

Only two additional data submissions are allowed for one Classification Application.

If a Classification Report is issued as a "awaiting additional data" for a new application;

• First additional data submission to be done within the three months from the date of first Classification Report issued.
• Second additional data submission to be done within three months from the date of second Classification Report issued

2. Sample Import Licence/ Formulation Approval

Sample Import Licence/ Formulation Approval requesting application to be submitted to NMRA within one year period from the date of approval of the Classification Report classified as a Borderline Product.

The valid period of Sample Import licence/ Formulation approval application is one year

3. Registration Dossier Submission.

Registration dossier to be submitted within the valid period of the Sample Import Licence/Formulation Approval.

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Notes:

If any applicant is failed to submit any of the above applications (1,2 & 3) within the valid period is subjected to reject the consignment clearance approval.

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