Questions & answers about regulating prescription and over-the-counter medicines
October 2006
Are there any restrictions to the granting of an interim product licence?
All products being lawfully supplied at the time the new scheme goes live will be granted a transitional approval allowing the product to continue being supplied in the local market for the proposed three year transition period. The supply of these products would be under the same terms and conditions as applied prior to commencement of the joint scheme. By the end of the proposed three year transition period a product sponsor must have applied to the Authority and been granted a full ANZTPA product licence to continue supplying the product.
Where do orphan products fit into the scheme?
The arrangements are described in the draft Medicines Rule (part 10).
Would the Rules pose barriers to the export of Class 2 medicines?
There are no barriers to exporting Class 2 medicines, rather a set of regulatory requirements that need to be followed.
What changes would have to be made to consumer medicine documents under the new scheme? Would extra safety information be required?
This issue is partly addressed in the draft Transition Guideline. Further guidance on compliance with the requirements of part 7 of the draft Medicines Rule will be issued in due course.
Would the scheme incorporate the ability for priority evaluation of medicines?
Yes. See division 3.4 of the draft Medicines Rule.
If conditional approvals for medicines are currently held in New Zealand, how would this be managed under the new scheme?
Part of the transition process will determine whether medicines are eligible for a full ANZTPA product licence. Conditional approvals will be reviewed on a case-by-case basis and could result in certain specific conditions being placed on the ANZTPA product licence.
Why not just have a transitional period rather than issue interim licences for products currently on the market in New Zealand and in Australia?
Interim product licences allow the products to continue to be supplied while allowing companies time to apply to the Authority for an ANZTPA product licence. The interim product licence will provide information and reassurance to companies and consumers about the status of the product.
What is the process that is required to apply for an interim product licence?
All products that are being legally supplied at the time the Authority is established will automatically be issued, free of charge, with an interim product licence. An interim product licence will allow a product to continue to be supplied in either Australia or New Zealand for the proposed three year transition period.
Could a company apply for the ANZTPA product licence in either Australia or New Zealand?
All applications will be processed through the Authority, whether the product licence is applied for in New Zealand or Australia.
If a medicine has been approved for use in say New Zealand or rejected for use in Australia – would it still be able to get a product licence under the new scheme? And would a sponsor be required to submit new data about the medicine?
These cases would be assessed on a case by case basis and may require the Authority to look at quality, safety and / or efficacy data.
How would the new regulatory scheme affect the regulation of sunscreens?
The claimed SPF will determine whether or not a sunscreen is treated as a cosmetic or a therapeutic product. It is proposed that all sunscreens over SPF 4 will be regulated by the Authority as Class 1 medicines.
Will there be a central system for clinical trials?
There will be clinical trial requirements for both countries under the new scheme. Certain trials will require assessment by the Authority prior to commencement; this process is separate from obtaining the endorsement of an ethics committee for the trial to proceed. If the trial is to be carried out in both Australia and New Zealand, ethics committee approval will need to be obtained in each country in order to satisfy each country’s ethical requirements.
What would the benefit be of a product licence?
A product licence will allow the product to be supplied in both Australia and New Zealand and the product sponsor would only have to pay one licence fee to gain access to both markets.
How would existing applications before Medsafe or the TGA be considered?
The current Medsafe and TGA application systems will stay in place until the Authority is established. All applications in the system at the time the Authority is established will be managed by the Authority and some sponsors may wish to apply immediately for a product licence.
What about compounding by pharmacists? Would the rights of a pharmacist to make up medicines for a patient be changed?
There are no changes proposed to how a pharmacist currently operates.
What is being done about duplications of clinical evaluation streams in New Zealand and Australia?
The Wellington and Canberra Offices will be resourced to provide efficient and effective evaluation capacity.
If a product is licensed in one country but not in the other, would it automatically gain entry into the other country under the new scheme?
An ANZTPA product licence would allow a product to be sold in both Australia and New Zealand.
How would the consumer know the difference between whether a product has an interim product licence or a full ANZTPA licence?
Full ANZTPA product licences will be issued with an identifying letter and number combination that will be required on labelling and marketing for therapeutic products.
Is there a timeframe or expectation for when the product labelling for medicines would need to meet the Authority requirements?
The proposed timeframe is three years. In order to gain a full ANZTPA product licence, the sponsor would need to demonstrate compliance with the ANZTPA labelling requirements. The product labelling requirement has been and continues to be subject to consultation.
What is the timeframe for getting a product licence for a prescription medicine after an application is submitted?
This will vary depending on the amount of assessment and evaluation required for the product. The maximum timeframe is 255 days. Target timeframes for the evaluation of prescription and over-the-counter medicines will be published and any applications not completed within the maximum target will be eligible for a partial fee reimbursement.
There is a concern that pharmaceutical companies may get their products registered in New Zealand because it’s easier to get them approved over there.
The ANZTPA will operate as a single entity under a common set of legislative requirements and standards. Internal policies and procedures will be developed to ensure consistency of standards and practices.
Will evaluation timelines be published?
Yes, target timeframes for the evaluation of prescription and over-the-counter medicines will be published.
URL: http://www.anztpa.org/pm/qapmotc.htm