Revised: February 2013

Medicines

Medsafe's Policy for Changing Registration Situation

Medsafe has revised its policy regarding the process for changing the registration situation in the Medsafe database.

Under the revised policy:

  • The registration situation will be updated to 'not available' when this is notified as part of the CMN/SACN receive and acknowledge process.
  • To change the registration status from 'not available' to 'consent given' or 'provisional consent', a CMN is required to be submitted and granted consent prior to the registration situation being updated and the product being reintroduced into the market.
  • For prescription or restricted medicines the CMN must include a revised data sheet to demonstrate that all required updates have been included. The CMN must undergo evaluation and self-assessable change notifications will not be accepted.
  • If it is determined that a CMN is not required because the regulatory file has been kept up to date, a justification letter should be provided to Medsafe. Medsafe will review the justification letter to ensure that all requests for CMNs have been addressed prior to the registration situation being updated and the product being reintroduced into the market.
  • CMNs or justification letters must be submitted at least 90 days prior to the intended date distribution will commence.
  • Justification letters, for the registration situation to be changed to 'consent given' or 'provisional consent', should be addressed to the Manager, Product Regulation.
  • Notification of changes in registration situation, from 'consent given' or 'provisional consent' to 'not available' or 'approval lapsed', can still be notified to Medsafe in writing at any time.
  • If approval has lapsed, consent to the distribution of a new medicine needs to be granted before the product can be reintroduced onto the New Zealand market.
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