Proposal for the supply of 5 mg folic acid tablets
Extended consultation period
We have become aware that some groups were not directly notified when our original consultation on this proposal was released in February 2021. To ensure you have a chance to respond we are sending this document directly to groups that may not have received it and allowing additional time for responses.
This consultation was emailed to subscribers on 21 May 2021.
What we’re proposing
We are seeking feedback on a proposal to change to the funded brand of 5 mg folic acid tablets currently supplied by Apotex New Zealand Limited (Apotex), following the announcement that it is leaving the New Zealand market.
This proposal would mean everyone using 5 mg folic acid would need to change brands to continue using a funded medicine. No changes are proposed to any dispensing or access restrictions that currently apply to this medicine.
The proposed brand of 5 mg folic acid tablets is not currently Medsafe approved and would need to be supplied initially under Section 29 of the Medicines Act.(external link)
Apotex, a pharmaceutical supplier, has made the decision to leave the New Zealand market from late 2021. Apotex currently supplies a number of pharmaceuticals in New Zealand. We’ve been working to secure alternative brands of these medicines to ensure continuity of supply for people taking the medicines.
One of the medicines Apotex currently supplies to New Zealand is 5 mg folic acid tablets. This proposal would mean that a funded brand of 5 mg folic acid tablets would continue to be available to New Zealanders who need it.
We are aware that Apotex also supplies 0.8 mg folic acid tablets to New Zealand. Further detail and regular updates of our progress towards sourcing an alternative brand of 0.8 mg folic acid tablets and other medicines in Apotex’s portfolio is available here.
Why we’re proposing this
Following Apotex New Zealand Limited’s announcement that it is leaving the New Zealand market, PHARMAC released a closed Request for Tenders on 1 October 2020. As a result of this procurement process and our analysis of the tender bids received, we have entered into provisional agreements with a number of suppliers for the supply of various medicines including folic acid.
Details about our proposal
From 1 July 2021 Mylan New Zealand Limited’s brand of 5 mg folic acid tablets would be be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:
|Chemical||Presentation||Proposed brand||Pack size||Proposed listing date|
|Folic acid||Tab 5 mg||Folic Acid Mylan||100||1 July 2021|
If this proposal is progressed it would mean we would secure supply of tab 5 mg folic acid tablets, however; it would mean people currently using 5 mg folic acid tablets would need to transition to the proposed brand from 1 July 2021.
The Folic Acid Mylan brand of folic acid is not currently Medsafe approved and would need to be supplied under Section 29(external link) of the Medicines Act initially. We consider it is important that 5 mg folic acid tablets continue to be funded and are proposing to fund an unapproved brand of 5 mg folic acid tablets, as we consider it is preferable to this medicine not being available to New Zealanders who need it. Mylan has committed to working towards Medsafe approval for its brand of 5 mg folic acid tablets.
Prescribers would need to support people to change brands of medicine as a result of this proposal. Prescribers would be supported with information to manage the proposed brand change in this proposal.
To provide feedback
Consultation is a very important step in our process. When providing consultation feedback, you might want to think about:
- The impact of 5 mg folic acid tablets being supplied to New Zealand as Unapproved Medicines for a period of time.
- If there is any information that we could provide to help assist these changes.
Send us an email: email@example.com by 4 pm Wednesday 2 June 2021.
All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.
Your feedback may be shared
Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request.
This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.
We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.