Guidelines and Codes
Abbreviated process for granting Provisional Consent under Section 23 of the Medicines Act 1981 to certain medicines currently supplied under Section 29 of the Act
On 17 March 2008 Medsafe will implement a new business rule to enable two categories of medicines that are currently supplied under Section 29 of the Medicines Act 1981 and used routinely in New Zealand hospital practice to be considered for approval under Section 23 of the Medicines Act (provisional consent).
The two medicine categories are:
- Category One: - Medicines that have been approved by other regulatory authorities recognised by Medsafe;
- Category Two: - Medicines for intravenous use that are manufactured in a New Zealand facility that is licensed under the Medicines Act to manufacture sterile medicines
Eligibility criteria for the Abbreviated Process
A product meeting the following criteria will be eligible for consideration for granting provisional consent to market under the terms of this new business rule:
For Category One products, the product must:
- be supplied currently under Section 29 of the Medicines Act 1981 for routine use in New Zealand hospital practice; and
- have been supplied under Section 29 to a minimum of 10 patients; and
- contain the same active ingredient as a medicine for which consent for distribution in New Zealand was granted more than 5 years prior to the date of this application; and
- must not contain the same active ingredient(s) in the same dose form as any other product currently available on the market in New Zealand with consent to distribution under Section 20 or Section 23 of the Medicines Act; and
- have been approved by either the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Health Products and Food Branch of Health Canada, the European Medicines Evaluation Agency (centralised procedure) or the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA); and
- be made by a manufacturer that is licensed or certified by one of the above recognised regulatory authorities as complying with GMP requirements for medicine manufacture.
For Category Two products, the product must:
- be supplied currently under Section 29 of the Medicines Act 1981 for routine use in New Zealand hospital practice; and
- be a simple IV solution; and
- be manufactured in a facility in New Zealand that is licensed under the Medicines Act 1981 to manufacture sterile medicines.
Application requirements
The sponsor of an eligible product may submit an application for provisional consent to distribute a medicine under Section 23 of the Medicines Act 1981.
The application must include:
- The name and contact details of the product sponsor;
- The name under which the medicine will be distributed;
- The qualitative and quantitative particulars for each ingredient in the product;
- A description of the dose form of the medicine;
- Details of the dosage, frequency of use and route of administration or method of use;
- The purposes for which the medicine is recommended to be used and the claims to be made in respect of the medicine;
- Evidence of approval and availability of a product containing the same active ingredient(s), in the New Zealand market, prior to the date five years before the provisional consent application is made;
- Evidence (for Category One products only) of the current approval of the product by a recognised regulatory authority (such as a copy of the product licence or approval notification);
- Evidence (for Category One products only) of the continued availability of that product in the country of the recognised regulatory authority;
- Evidence that the product is made in a GMP-licensed facility, such as a copy of a GMP licence specifying manufacture of the applicable product at the specified manufacturing site;
- Evidence of routine use of the product in New Zealand hospital practice;
- Endorsement of the continued use of the medicine by a hospital drug committee and details of the volume of the medicine used over the preceding three-year period;
- Certification that the product labeling complies either with the New Zealand requirements or with the requirements of the recognised overseas regulatory authority and with New Zealand Misuse of Drugs legislation (if applicable);
- Certification (for Category 1 products only) that the Data sheet (if required) for the product is identical to that approved by the recognised regulatory authority;
- Certification (for Category 1 products only) that the product supplied in New Zealand is identical to that approved by the recognised overseas regulatory authority.
Fees
The fee for evaluation of an eligible medicine for provisional consent will be $8437 GST inclusive. Medsafe will make a case-by-case determination of whether or not this application fee may be partially waived in the public good. Factors such as volume of use in New Zealand, and determination of whether the product has orphan drug status in other jurisdictions, will help inform Medsafe's decision.
Provisional consent conditions
A provisional consent issued under Section 23 of the Medicines Act remains in effect for a period of not more than two years and may be subject to conditions. In the case of a consent issued under this mechanism, conditions may be imposed on the use of the product, such as placing restrictions on where and by whom the medicine may be used.
Products supplied under Section 29 that do not meet the criteria for the provisional consent mechanism
Products that do not meet the criteria set out above will not be eligible for consideration for issue of a provisional consent under this abbreviated mechanism. Products currently being lawfully supplied under Section 29 of the Medicines Act may continue to be supplied in this way subject to the existing requirements set out in the legislation, including the reporting requirements.