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Guidelines & Codes

Explanatory Note on Section 6.6 Submitting an Application or Notification.
RETURN OF INCOMPLETE DOSSIERS

Added to web site: October 2006

As a result of receipt of an increasing number of incomplete dossiers and dossiers that are incorrectly labelled, paginated or indexed, Medsafe advises that as of 1 August 2006, we will reject and return all such dossiers at the applicant’s expense. (Please note the updated Section 6.3 to the NZRGM Vol 1, 5th Edition regarding preferred format for new Prescription Medicine applications.)

When sending dossiers please ensure that:

1. all dossiers that are delivered in boxes are labelled clearly on at least two sides that are visible when the box is stacked.
2. the label includes:
   • the box number and the total number of boxes associated with the application (e.g. Box 1 of 5)
   • the name of the product
   • the TT50- file number, if applicable
   • the contents of each box by module and volume number
3. modules 1 & 2 are included in Box 1 (if more than one box), together with a cover letter if there is one, and the payment details. If possible, the label of box 1 is identifiable by colour.
4. each box only contains documentation relating to one New Medicine Application.
5. each box weighs less than 15Kg

Please note that any fee paid for dossiers that are returned will be non-refundable, and if no payment is apparent in the application the company will be invoiced. If a company wishes to resubmit, this will be a new application with a new fee.
Incomplete dossiers will be returned to the applicant at the applicant’s expense.

Applicants should contact Medsafe prior to submission of their medicine dossier if they have any questions.