Q&A: marketing authorisation for pharmaceuticals and medical devices in New Zealand

Marketing authorisation

How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) aims to complete its full evaluation of a medicine application (NMA) within 200 calendar days of receipt of the application. The application fee ranges from NZ$10,220 to NZ$102,210. An abbreviated evaluation of an NMA takes up to 100 days, and the application fee is from NZ$21,940 to NZ$51,100. The fee and time frame depend on the risk classification of the new medicine (ie low, intermediate or high), the amount and complexity of the clinical information provided and the response time of the sponsor if further information is required by Medsafe.

Once a medicine is approved, the authorisation remains valid until it ‘lapses’ in the following circumstances:

• the medicine has not been available in New Zealand and there has been no regulatory activity undertaken by the New Zealand sponsor in respect of the medicine for more than five years; or
• the New Zealand sponsor has advised the regulator, Medsafe, that the product is no longer being distributed in New Zealand.

If an approval has ‘lapsed’, then the medicine is considered a ‘new medicine’, and a new approval must be obtained before it can be reintroduced onto the New Zealand market.

What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?

The Medicines Act only protects the confidentiality of supporting information (including trade secrets and information of commercial value to the applicant) given in relation to an ‘innovative medicine application’. That protection lasts for five years from the date approval is granted.

An ‘innovative medicine application’ is an application for approval of a medicine that contains an active ingredient that has not, before that application is received by Medsafe, been referred to in any other application as an active ingredient of a medicine.

The Medicines Act does not provide for any data exclusivity for new uses of a previously approved medicine, for any change in pharmaceutical form or any other type of ‘market exclusivity’ protections that apply in some other jurisdictions.

There are no data exclusivity protections associated with medical devices in New Zealand.

To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?

Anyone can request research data relating to a therapeutic product held by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) under the Official Information Act 1982 (OIA) at any time.

Under the OIA, all information held by a government agency, which includes Medsafe, is to be made available unless there is a ‘good reason’ or ‘conclusive reason’ for withholding it, including protecting the trade secrets of the applicant, avoiding unreasonably prejudicing the commercial position of the applicant, or if disclosure would be likely to ‘seriously damage the economy’ of New Zealand. The reasons for withholding must be weighed against the overall public interest in disclosure (unless a ‘conclusive reason’ for disclosure applies).

Where the research data is subject to the five-year data exclusivity protection under the Medicines Act, the interest in withholding to protect the applicant’s trade secret and commercial position strongly outweighs the interest in disclosure. While this becomes less so the more time passes after the exclusivity protection has expired, Medsafe is still required to take into account the commercial sensitivity of the research data and the interest of the applicant when deciding whether to disclose the data following any appropriate consultations with the applicant.

Are there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?

Herbal and homeopathic remedies do not generally require the New Zealand Medicines and Medical Devices Safety Authority's (Medsafe) approval for sale and supply in New Zealand, so long as they do not contain any prescription, restricted or pharmacy-only medicine and no ‘therapeutic claim’ is made in relation to them.

Biologics, biosimilars, orphan drugs and drugs for paediatric use that are used wholly or principally for a ‘therapeutic purpose’ are treated in the same way as other medicines and must undergo the same approval processes prior to distribution in New Zealand.

Controlled drugs (being drugs commonly misused by the public) can only be imported, manufactured, sold or supplied in New Zealand under a licence issued by Medicines Control in accordance with the Misuse of Drugs Act 1975. The list of controlled drugs in that Act is amended by legislative processes rather than regulatory control delegated to the relevant government agency.

What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?

The Medicines Act requires the New Zealand importer or manufacturer of the medicine to report adverse events that they become aware of to the Director-General of Health. Failure to do so is an offence. New Zealand operates a Centre for Adverse Reactions Monitoring, which receives and collates adverse event reports from healthcare professionals, the general public and pharmaceutical companies.

What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?

A licence to manufacture medicines issued by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is required to manufacture prescription medicines, while a wholesale licence is required to import, export and conduct wholesale distribution and storage of prescription medicines. The New Zealand based sponsor of the medicine must apply for and hold the licence.

Licence applications generally take 12 weeks to process. The licence is only valid for one year and must be reapplied for annually.

The licence fee for a licence to manufacture medicines is NZ$13,750 and NZ$10,77.42 for a wholesale licence.

Pre-market approval of medical devices is not currently required in New Zealand. The medical device only needs to be registered on Medsafe’s Web Assisted Notification of Devices (WAND) Database within 30 working days of the medical device being manufactured or first arriving in New Zealand. There are no charges associated with this registration.

What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?

Every person who contravenes Medsafe’s licensing requirements in relation to a medicine is liable on conviction to a fine not exceeding NZ$40,000. In some circumstances, individuals can face imprisonment for up to six months, and companies can be fined up to NZ$100,000. Directors and employees can be held liable for an offence committed by a company if those individuals approved the breach, or failed to take all reasonable steps to prevent or stop a breach that they knew about.

Any person who fails to register a medical device on the WAND Database prior to its importation or wholesale distribution is liable on conviction to a fine not exceeding NZ$500.

What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?

A registered healthcare professional is not required to obtain regulatory approval or a licence to manufacture and supply a prescription medicine that is not currently approved in New Zealand if the supply is to a named patient under that healthcare professional’s care.

The pharmacist preparing and dispensing the unapproved medicine pursuant to a prescription issued by the healthcare professional in this situation is also covered by the exemption.

The sponsor of the unapproved medicine must report the importation, sale or supply of the unapproved medicine to Medsafe, including the name of the healthcare professional and the patient.

Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?

The importation of an unapproved medicine is allowed where a registered healthcare professional is obtaining the medicine for the care of a named patient, for approved clinical trials, or where an individual is importing small quantities for personal use. Other than in these situations, the importer will be required to obtain New Zealand approval for the medicine before importing it for the purpose of supply.