DSOIA512 Attachment.pdf

1982
Act
Information
Official
the
under
Released

Al owin
Document 1 g the sale of pseudoephedrine-based cold and flu medicines
Cabinet
Changes to the MoDA and
Medsafe
Manufacturers supply
decision
Medicines Regulations
approval process
to New Zealand
1982
Act
Key points
Information
• Cabinet has agreed to amend the Misuse of Drugs Act 1975 (and associated regulations) and the Medicines Regulations 1984 to
al ow pseudoephedrine-based cold and flu medicines to be sold in New Zealand pharmacies.
• These amendments wil be ready for the Legislation Committee meeting on 28 February.
Official
• Medsafe is ready to expedite and simplify approval processes.
the
• Manufacturers are likely to begin submitting their applications to Medsafe for product approval, once the changes are
announced.
• To ensure pseudoephedrine-based cold and flu products
under are approved as quickly as possible, Medsafe wil use the provisional
approval pathway.
• Timeliness of access to pseudoephedrine-based cold and flu medicines is dependent on suppliers. Pharmaceutical companies
decide when to apply for product approval, when to enter the market, what products they want to market, and manufacturing
lead times.
Released
2

Deliver
Document 1 ing legislation and regulation changes
Cabinet
Changes to the MoDA and
Medsafe
Manufacturers supply
decision
Medicines Regulations
approval process
to New Zealand
1982
Act
Key points
Information
• Publicly announcing Cabinet’s decision to amend the Misuse of Drugs Act and the Medicines Regulations wil provide industry
stakeholders with certainty over the new legislative settings for pseudoephedrine in New Zealand.
• Ministry of Health officials are working with the PCO to align the legislative amendments with the current regulatory settings in
Official
Australia. The purpose of this is to make it easier for manufacturers already supplying the Australian market to also supply the
New Zealand market.
the
• Ministry officials wil be prepared should you choose to move an urgency motion for these amendments. However, we do not
expect this to speed up supply.
under
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3

Expedi
Document 1 ting the approval process
Cabinet
Changes to the MoDA and
Medsafe
Manufacturers supply
decision
Medicines Regulations
approval process
to New Zealand
1982
Act
Key points
Information
• Medsafe wil  use the provisional approval pathway for pseudoephedrine-based cold and flu products. Provisional product
approvals have been used in other scenarios, including for COVID vaccines (where there was a clinical need but some data were
not available), and to help Pharmac al eviate stock shortages.Official
• Products granted provisional approval by Medsafe would be expected to be converted into full approval within a reasonable
amount of time (approximately 1 year). This is unlikely to be
the  an issue for pharmaceutical companies.
• A determining factor in the timeliness of the approval process is how quickly applicants respond to requests for information sent
by Medsafe.
under
• Medsafe wil  need to manage the volume of applications it receives. To do this Medsafe wil  request ‘expressions of interest’
from companies via their website and through industry groups. Companies could supply details such as products, ingredients,
indications and dose forms, expected submission date, and expected date to market, which Medsafe would use to prioritise
applications.
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4

Encoura
Document 1 ging manufacturers to put pseudoephedrine on shelves
Cabinet
Changes to the MoDA and
Medsafe
Manufacturers supply
decision
Medicines Regulations
approval process
to New Zealand
1982
Act
Key points
Information
• Early feedback received from industry stakeholders indicates that manufacture lead times for pseudoephedrine-based cold and
flu products are several months. This timeframe is what has been observed for other medicine changes.
• Pharmaceutical supply chains are complex. Manufacturers wil need to determine where product for the New Zealand market is
Official
to be manufactured, how it is manufactured, what the label ing requirements are, as wel as other supply chain considerations.
the
• However, it may be possible that pharmaceutical companies already supplying pseudoephedrine-based cold and flu products to
the Australian market could divert some of these products to the New Zealand market.
under
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Comm
Document 1 unicating with affected stakeholders throughout
Cabinet
Changes to the MoDA and
Medsafe
Manufacturers supply
decision
Medicines Regulations
approval process
to New Zealand
1982
Act
Key points
Information
• Fol owing your announcement of Cabinet’s decision to reclassify pseudoephedrine, Medsafe wil  publish an item on their website
inviting ‘expressions of interest’ from manufacturers. Medsafe is developing a strategy for accepting applications and
determining data requirements.
Official
• It wil  be important that communication with stakeholders is clear and pragmatic. Ministry of Health officials are developing a
communications plan to ensure that affected stakeholders (c
the  onsumers, pharmacists, suppliers, etc.) are kept informed of any
developments.
under
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6

Summa
Document 1 ry
Cabinet
Changes to the MoDA and
Medsafe
Manufacturers supply
decision
Medicines Regulations
approval process
to New Zealand
1982
Act
Key points
Information
• The amendments to the Misuse of Drugs Act and the Medicines Regulations wil  align New Zealand’s regulatory settings with
Australia to enable existing manufacturers to quickly supply the New Zealand market.
• Officials are working to make processes timely, while ensuring that pseudoephedrine-based cold and flu products to be available
Official
in New Zealand are of appropriate quality.
the
• Fol owing your announcement of the changes, we anticipate that pharmaceutical companies wil  begin the process of applying to
Medsafe for product approval. This wil  al ow the approval process to happen alongside the work to amend the legislation and
regulations.
under
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1982
Act
Information
Official
the
under
Released

IN CONFIDENCE
Document 2
Next steps
Once you have publicly announced the new regulatory settings agreed to by Cabinet, Medsafe wil publish an
item on its website inviting ‘expressions of interest’ from manufacturers.
We wil continue to work with the PCO to draft the legislative amendments. These wil be ready for the
Legislation Committee meeting on 28 February 2024.
Deputy Director-General
Maree Roberts, Deputy Director-General, Strategy Policy &
Legislation – Te Pou Rautaki, s 9(2)(a)
1982
Act
Information
Official
the
under
Released
7
IN CONFIDENCE

1982
Act
Information
Official
the
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Released

Document 5
IN CONFIDENCE
Applications for provisional approval are due by 8 March 2024. Medsafe is expecting between eight and 14
applications.
The timeline for evaluation and approval is dependent on the quality of the applications and time taken for
applicants to provide any further information requested.
Suppliers will be proceeding under the assumption that pseudoephedrine is to be rescheduled as a C3
controlled drug following enactment of the Misuse of Drugs (Pseudoephedrine) Amendment Bill. They
noted this presents a commercial risk that they are willing to carry.
Medsafe remains on track to make approval decisions in May 2024 if companies provide information in the
expected timeframe.
Next steps
The Health Select Committee is scheduled to report back to the House on the Bill on 14 March 2024.
The expected date for the Second Reading of the Bill is 19 March 2024, with the Committee Stage and the
Third Reading occurring in the week of 25 March 2024. The Ministry will provide the necessary material to
support you in the House.
Deputy Director-General
Maree Roberts, Deputy Director-General, Strategy Policy &
Legislation – Te Pou Rautaki, s 9(2)(a)

under the Official Information Act 1982
Released