Published: 11 June 2018

Medicines

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:

  • What is the reason for the OOS issue?
  • How much stock is there in the supply chain (include supply held by the sponsor, wholesalers and retailers)?
  • How long will the current stock last (include total volume and weekly/monthly usage in response)?
  • What steps have been taken to resolve the OOS issue?
  • What action do you propose to resolve and/or mitigate the impact of the OOS issue?
  • What clinically equivalent or alternate products are:
    1. approved in NZ, available and PHARMAC funded;
    2. approved in NZ, available but not PHARMAC funded;
    3. approved in NZ but not currently available;
    4. not approved for use in NZ but able to be obtained to meet clinical need.
  • Is any regulatory activity required for either a proposed alternate product, or to enable supply of the current product?
  • Will any regulatory activity require urgent assessment in order to prevent an OOS situation?
    • If so, Medsafe requires a priority support letter (eg, from PHARMAC) that confirms the proposed course of action best mitigates the risk of disruption to patients. If the medicine is PHARMAC funded, PHARMAC must be informed and support the proposed course of action.

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@health.govt.nz.

Sponsors should notify Medsafe of a potential OOS issue where regulatory action is required via medsafeapplications@health.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:

  • manufacturing delays
  • product recalls
  • transport-related temperature deviations
  • stability issues identified during stability monitoring
  • product received in NZ is not as per NZ approved product
  • discontinuation of active pharmaceutical ingredient (API)/medicine product
  • worldwide shortage of API/medicine product
  • delays as a result of import licence requirements
  • Good Manufacturing Practice (GMP) issues.

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.

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