Medicines

Published: 11 June 2018

What to do in the case of a potential out of stock

Key Messages

  • Essential medicines used in New Zealand should be available for supply.
  • PHARMAC contracts may also include additional supply obligations.
  • Inform Medsafe of a potential out of stock issue as soon as possible.

Do you have a potential out of stock (OOS) issue that may require regulatory action? 

Medsafe should be informed of an OOS issue that may require regulatory action as soon as possible. In situations where regulatory action is required to resolve a potential OOS event, clear, informative communication with Medsafe can help minimise disruption to Medsafe workflows and may allow for a faster, easier resolution.

Medsafe (which includes Medicines Control) works in collaboration with PHARMAC (if the product is listed on the Pharmaceutical Schedule) to assist with the resolution of OOS issues, to ensure continued availability of essential medicines for New Zealand patients.

What information does Medsafe require?

Please provide the following information:

All supporting information relating to a potential OOS issue that requires regulatory action should be included in the cover letter that accompanies the application.

Further information is available on the definitions of registration situations and Medsafe’s policy for changing registration situations.

How to notify Medsafe

Sponsors should notify Medsafe of a potential OOS issue associated with a potential quality (including GMP) issue with a medicine via recalls@moh.govt.nz.

Sponsors should notify Medsafe of a potential OOS issue where regulatory action is required via medsafeapplications@moh.govt.nz.

How do OOS issues occur?

A product recall could cause an OOS issue that may require regulatory action. Refer to the recalls code for further information on how a product recall is decided on and executed.

Other factors that may create an impending OOS issue include:

Resolving OOS issues in compliance with the Medicines Act 1981

The sponsor should determine whether any of the following regulatory actions are required to address the potential OOS issue:

  1.  pre-market assessment and approval of a new medicine via the full or abbreviated New Medicine Application (NMA) regulatory pathway; or
  2.  pre-market assessment and approval of a changed medicine via the Changed Medicine Notification (CMN) or CMN section 24(5) regulatory pathway.

Indicative evaluation timeframes for each regulatory provision above can be found at www.medsafe.govt.nz/regulatory/EvaluationTimeframesAndRegistrationSituation.asp. It is pertinent to note that well formatted, comprehensive, high quality applications are likely to minimise delays to evaluation timeframes.

If time does not permit for the standard indicative timelines of regulatory activities to prevent a potential OOS issue, a request for priority assessment can be made to Medsafe at the time the application is submitted. Medsafe offers priority assessment under three criteria, further outlined in Section 3.5 of Part 2 of the Current Guidelines on the Regulation of Therapeutic Products in New Zealand. These criteria apply to NMAs only (this includes CMNs referred under Section 24(5) of the Medicines Act 1981).

Note that CMNs are not eligible for priority assessment. However, Medsafe may adjust its workflows for CMNs in cases where an expedited assessment would ensure patient treatment with critical medicines is not interrupted.

Sponsors should note that urgent assessment can consume significant resource and have a disruptive downstream effect on Medsafe’s workflows. Priority designation is always dependant on available Medsafe resource.

In addition, post-market action on medicines currently in the market place may be required in some instances.

Resolving OOS issues in compliance with the Misuse of Drugs Act 1971:

See ‘Licence to Import Controlled Drugs’ workflow.

Licence to Import Controlled Drug Workflow

Applicants should allow up to 30 working days for the processing of import applications.