The Medicines Amendment Bill introduces a verification pathway under which medicines can be approved for distribution in New Zealand if they have been approved by 2 recognised overseas jurisdictions.
On this page:
-
…
Verification pathway details set out in the Bill
The Bill sets out requirements that medicines must meet to be considered through the verification pathway. Medsafe has met with individual companies and considers most companies applying for the verification approval in New Zealand will be able to use it.
The Bill provides that for a medicine to be considered for the verification pathway, it must have full marketing authorisation granted by 2 or more recognised authorities. The medicine to be supplied in New Zealand must be identical in all material respects to the medicine authorised, with allowance for minor difference.
It also provides that the Director-General of Health must be satisfied that the medicine:
- has not been rejected, withdrawn, or is pending deferral by a recognised regulatory authority for quality, safety or efficacy reasons,
- has not been subject to any regulatory action that may result, or has resulted in, a suspension or revocation of the market authorisation by any recognised regulatory authorities,
- does not need an independent assessment by Medsafe to contextualise the benefit-risk profile due to local disease epidemiology, public health considerations or New Zealand specific health risks.
These requirements ensure that there can be additional evaluation by Medsafe in the few circumstances where this is appropriate.
Processes for the verification pathway to be set in secondary legislation
Due to the technical nature of the details of the pathway, the Bill provides for the operational policies of the pathway to be set out in secondary legislation (rules) made by the Minister of Health.
The Bill is currently being consulted on as part of the Select Committee process. Because the specifics of the verification pathway will be set out in secondary legislation, this is not part of the consultation. However, we have provided information on how the pathway could operate to provide better visibility of what the whole package could look like.
The information below is indicative only, to aid understanding of the potential package. Once the Bill is passed, the draft rules will be developed, which will include a full public consultation process.
Indicative draft processes
The rules may set out the process for applying for verification by consent, for example by setting a timeframe for Medsafe to make a decision on a verification application at 30 working days.
The rules may also set out the requirements for the application itself, such as the documentation required for an application. For example, inclusion of the reports from the two overseas jurisdictions, and New Zealand-specific information for the medicine, as proposed in the Bill.
Further requirements may relate to ensuring that:
- manufacturing sites associated with the product have evidence of Good Manufacturing Practice (GMP) compliance which is valid to Medsafe’s satisfaction.
- if a product is a generic or biosimilar prescription medicine, the innovator or reference product is identical to that approved for New Zealand.
Indicative verification pathway workflow
The diagram below sets out the indicative process for the verification pathway, noting that this will be further developed and consulted on after the Bill is enacted.
Text description
1: Pre-submission of application (not mandatory but strongly recommended)
- Sponsor submits first part of application form.
- Medsafe and sponsor may meet to discuss application.
2: Validation of application (screening) (10 working days)
- Full application submitted to Medsafe.
- Screening begins on payment of validation fee.
- Application screened by Medsafe.
- Medsafe may ask the company to rectify any issues.
3: Verification of application
- Day 0: Process begins on payment of application fee.
- Day 20: initial evaluation completed.
- Any requests for further information sent by day 20.
- Allow 20 days for response (clock stops).
- Day 25: evaluation of response completed.
- Recommendation to Minister’s delegate for decision.
4: Decision
- Day 30: Decision notified to applicant
Medicines approval pathways
The proposed verification pathway will be an additional pathway option for companies, on top of the two Medsafe already has.
As part of the verification process, Medsafe will encourage applicants to discuss any potential applications prior to submitting an application. This will enable Medsafe to ensure that applications can be made in the most efficient way, and to work with applicants on the most appropriate pathway for their product. It also gives companies certainty about which option will be best for their application.
Full assessment pathway (existing)
Can be used when companies want to seek approval in New Zealand before seeking approval in other markets, or where assessment of the medicine has not been completed by overseas regulator. This pathway requires a full application and assessment process.
Abbreviated assessment pathway (existing)
Can be used when a medicine has been approved from one trusted regulator. This pathway requires a lighter independent assessment of the approving country’s assessment report. This pathway is quicker and cheaper than a full assessment.
Verification pathway
Can be used when a medicine has been approved by two of the trusted overseas regulators that are identified in the Bill and do not require additional review by Medsafe to manage risks unique to those products (additional review expected to be rare). This pathway is proposed to have a maximum timeframe for Medsafe decision of 30 days.
You can find more information about the full and abbreviated assessment pathways on Medsafe’s website.
