Transition to the joint regulatory scheme for complementary medicines
19 August 2005
- Introduction
- Proposed arrangements for the transition of complementary medicines to the trans-Tasman regulatory scheme
- Frequently asked questions
Introduction
- Transitional arrangements will be required to give sponsors and manufacturers of complementary medicines in Australia and New Zealand time to achieve compliance with regulatory requirements under the joint scheme. These arrangements will be based on the principles set out in the Treaty.
- Sponsors of products that meet the definition of a complementary medicine who are legally supplying those products in Australia or New Zealand prior to commencement of the joint scheme will qualify for a transitional approval to be known as an interim product licence. This licence will authorise the continued supply of the product, in the jurisdiction in which it was previously being lawfully supplied, for the duration of a defined transition period.
- Manufacturers of complementary medicines who are lawfully manufacturing products prior to commencement of the joint scheme will qualify for an interim manufacturing licence, authorising the continued manufacture of those products for the duration of a defined transition period.
- Persons who wish to continue to supply and/or manufacture products beyond the end of the defined transition period must apply to the Agency for a full Agency product licence or manufacturing licence and must meet all the requirements of the joint scheme.
- Following commencement of the joint scheme, anyone who manufactures or supplies complementary medicines without holding either an interim or a full Agency licence authorising them do so, will be acting unlawfully and will be exposing themselves to enforcement action by the Agency.
- It will be necessary for New Zealand sponsors to request an interim product licence or manufacturing licence. At present, there is no "register" of sponsors, manufacturers or products. Therefore the Joint Agency Establishment Group will make available a central interim register for New Zealand sponsors and manufacturers of products that will be regulated as complementary medicines under the joint scheme.
- In order to be issued an interim product licence or interim manufacturing licence, sponsors and/or manufacturers will need to enter details of the products they supply and/or manufacture in New Zealand. The interim licence will enable the supply and/or manufacture to continue until a full Agency product licence or manufacturing licence is granted, or the transition period ends (whichever comes first).
Proposed arrangements for the transition of complementary medicines to the trans-Tasman regulatory scheme
a) Background
The general principles for the transition of all therapeutic products to the joint regulatory scheme have been considered.
The impact of the joint regulatory scheme on suppliers and manufacturers of therapeutic products will vary depending on how the specific products are regulated currently in Australia and New Zealand.
New Zealand sponsors and manufacturers of products that are currently being sold as dietary supplements but will become complementary medicines under the new legislation will not have been subject to regulatory requirements similar to those contained in the harmonised scheme. Transitional arrangements will be required to give sponsors time to meet the joint agency regulatory requirements. These arrangements will be based on the principles set out in the Treaty.
Under the proposed harmonised regulatory scheme, approval to supply a medicine will take the form of a product licence.
Approval to manufacture a medicine will take the form of a manufacturing licence. In order to obtain a manufacturing licence, manufacturers will need to demonstrate that the manufacturing principles (including compliance with the code of GMP) have been met.
b) Transitional approvals
The treaty obligations on both countries mean that at commencement of the Agency, all products that could be lawfully supplied in Australia or New Zealand can continue to be supplied in the country in which they were being supplied lawfully, for the duration of a specified transition period.
In practical terms this means that all products included on the Australian Register of Therapeutic Goods (ARTG) will be granted a transitional approval in the form of an interim product licence that applies in Australia only. These interim product licences will apply the same conditions as applied to the inclusion of that product on the ARTG under the Therapeutic Goods Act.
Likewise, in New Zealand, any product that has been granted Ministerial consent or provisional consent under the New Zealand Medicines Act will be granted a transitional approval in the form of an interim product licence which applies in New Zealand only. Additionally any product that is being lawfully supplied as a dietary supplement in New Zealand prior to the commencement of the Agency but fits the definition of complementary medicine under the joint scheme will be granted a transitional approval in the form of an interim product licence that applies in New Zealand only.
The Ministerial Council Rules (the subordinate legislation for the harmonised scheme) will provide for the period for which the interim product licences will be valid.
c) Creating an interim register of New Zealand products
In order to collect information about the products sold as dietary supplements in New Zealand that will become complementary medicines under the new legislation, a process for entering the details of these products onto an interim register has been developed. Entry on the interim register will enable interim product and/or manufacturing licences to be issued and enable the supply and/or manufacture to continue in New Zealand for the duration of the transition period.
d) Obtaining a full Agency licence
Sponsors who wish to continue to supply or manufacture products in Australia or New Zealand beyond the expiry of the transition period, including products on the interim New Zealand register, will need to apply for (and be granted) a full Agency product licence (and/or manufacturing licence) before the end of the transition period, as the interim licence will lapse when the transition period ends.
Sponsors of low risk (Class I) medicines, including most complementary medicines, will apply for a product licence on-line. An applicant will have to declare that their product conforms to all the Agency’s requirements for obtaining the licence.
Any ingredients in Class I medicines that are not on the Agency’s "permitted ingredients list" at commencement of the joint scheme will, on application, be assessed for suitability to be added to the list of active ingredients permitted for inclusion in Class I medicines. If the ingredient is added to that list (and the product meets all other requirements), the product will be given a full Agency product licence that enables the product to be supplied in Australia and New Zealand.
Sponsors of higher risk (Class II) medicines will also need to apply for and be granted a full joint agency product licence. The degree of evaluation carried out will depend on the regulatory status of the product prior to commencement of the Agency. The details of this process are being developed in consultation with industry.
Having demonstrated compliance with all Agency standards (and having paid the applicable fee), a full Agency product and/or manufacturing licence will be issued enabling supply in and/or manufacture for both Australia and New Zealand. The extent of supply will be a marketing decision of the sponsor. (There will not be single country licences under the scheme.)
It is proposed that the fee for moving from an interim to a full Agency product or manufacturing licence will be discounted compared to the full fee for obtaining a new product or manufacturing licence.
Frequently Asked Questions
Complementary Medicines
Q1 Are products evaluated by TGA and assessed as suitable for supply in Australia prior to commencement of the Agency, considered suitable for supply in New Zealand following startup of the joint agency even if the product has not been evaluated by Medsafe?
Yes. There is no evidence to suggest that the TGA has approved products that do not meet the standards required by Medsafe. These products will be deemed suitable for a full Agency product licence without further evaluation of data but with an assessment to ensure they meet Orders (e.g. the labelling order) and joint agency guidelines for details such as product information, consumer medicine information, approved indications and shelf-life. The Agency will have the power to request relevant information from the sponsor.
Q2 Are products evaluated by Medsafe, and assessed as suitable for supply in New Zealand prior to commencement of the Agency, considered suitable for supply in Australia following start-up of the joint agency even if the product has not been evaluated by the TGA?
Yes. There is no evidence to suggest that Medsafe has approved products that do not meet the standards required by the TGA. These products will be deemed suitable for a full Agency product licence without further evaluation of data but with an assessment to ensure they meet Orders (e.g. the labelling order) and joint agency guidelines for details such as product information, consumer medicine information, approved indications and shelf-life. The Agency will have the power to request relevant information from the sponsor.
Q3 What is the length of the transition period for the different product types?
The transition period for all medicines will be three years from commencement of the Agency. All medicines that are the subject of an interim product licence will need to apply for a full Agency product licence within three years of commencement of the Agency.
Q4 How long will a transitional manufacturing approval be valid for?
Manufacturers of medicines that were licensed by either the TGA or Medsafe prior to the commencement of the Agency will be granted a transitional manufacturing licence that will be valid for two years. These Australian and New Zealand based manufacturers will need to apply to the Agency for a full Agency manufacturing licence within nine months of commencement of the Agency. Following the application period, audits of manufacturing sites will be scheduled. These audits will ensure compliance with the Agency code of GMP and will be completed within two years of commencement of the Agency.
Products manufactured by these manufacturers, under an interim manufacturing licence, would be eligible for a full Agency product licence provided that all other Agency requirements were met. Under these circumstances, the full Agency product licence would be subject to the condition that failure to obtain a full manufacturing licence by an agreed date would result in suspension of the product licence.
Lawful, unlicensed manufacturers of products meeting the definition of complementary medicine in New Zealand prior to commencement of the Agency will also be granted an interim manufacturing licence that will enable them to continue the activities that they were lawfully undertaking prior to commencement of the Agency. In order for these interim manufacturing licences to be issued, an interim database of unlicensed manufacturers of complementary medicines will need to be established prior to commencement of the Agency.
A full Agency product licence could not be granted for products manufactured by these anufacturers until such time as they have been audited for compliance with the Agency code of GMP and a full manufacturing licence is issued by the Agency.
Q5 What will be the cost of obtaining and maintaining a transitional approval?
All interim (manufacturing and product) licences will attract a fee. These licences will be issued at commencement of the Agency to all current New Zealand and Australian licensed manufacturers (and those on the interim register of manufacturers in New Zealand), to all sponsors of products listed, registered or included on the ARTG and medicines with Ministerial consent in New Zealand (and those on the interim register of products in New Zealand).
The fee incurred for holding an interim licence will be considered as the first annual fee for maintaining an Agency licence.
Note:- The incentive for New Zealand manufacturers and sponsors of complementary medicines to obtain an interim licence (ie to enter their details onto the interim registers) will be in the fee structures for obtaining a full Agency licence.
Full Agency licence applications will receive a significant fee reduction if the full Agency licence is replacing a valid interim licence. If no valid interim licence is in operation, the application for a full Agency licence will be treated as an application for a new product or a new manufacturer and will incur the full fee.
In addition, manufacture, supply, import or export of therapeutic products in Australia and/or New Zealand will be illegal unless covered by a valid interim (or full Agency) licence and will be liable to prosecution under the new therapeutic products legislation in each country.
Q6 Will complementary medicines that are currently included in the ARTG be granted a full Agency product licence as soon as compliance with joint agency labelling requirements has been demonstrated?
Full Agency product licences will only be granted for these products following successful application to the Agency by the sponsor. As part of the application for a full Agency product licence, the sponsor will need to certify that the product labelling complies with Agency requirements and that advertising complies with the Joint Advertising Code. Sponsors will also need to recertify that they hold evidence to support any claims made in relation to the product and that the product is manufactured to standards acceptable by the Agency. If the product is manufactured in Australia and/or New Zealand, the sponsor will need to certify that the manufacturer holds either an interim manufacturing licence or a full Agency manufacturing licence. Applications may be audited by the Agency to ensure sponsor certifications are correct.
Note:-Manufacturers who were manufacturing medicines in Australia and/or New Zealand prior to commencement of the Agency will be granted an interim manufacturing licence allowing continued manufacturing under the same terms permitted prior to commencement. A full Agency manufacturing licence will not be granted until the manufacturer has applied to the Agency and successfully passed an audit to ensure compliance with the Agency Code of GMP.
Q7 What will be the process for lawfully supplied New Zealand complementary medicines?
A database of products fitting the definition of complementary medicines that are being lawfully supplied in New Zealand prior to commencement of the Agency has been constructed. This database is collecting information about the medicine, its sponsor and its manufacturer. Interim product licences will be issued to the sponsors of products entered onto this database prior to commencement of the Agency. Complementary medicines that are being supplied in New Zealand prior to commencement of the Agency that are not entered onto the database will not be granted an interim product licence. It will be illegal to supply a therapeutic product in Australia and/or New Zealand after commencement of the Agency if the product is not the subject of either an interim or a full Agency product licence.
A full Agency product licence will only be granted for these products following successful application to the Agency by the sponsor. It is assumed that the vast majority of products falling into this category will be classified as Class I medicines.
For products supplied in New Zealand and entered on the interim register, the application to convert an interim product licence to a full Agency product licence would be the same as the process for a new Class I medicine. As part of this process, if the product is manufactured in Australia and/or New Zealand, the sponsor will need to certify that the product is manufactured in accordance with the Agency Code of GMP by a manufacturer that holds a full Agency manufacturing licence. A full Agency product licence could be issued if the manufacturer holds an interim manufacturing licence, provided that the manufacturer was licensed by either the TGA or Medsafe prior to commencement of the Agency.
For Australian complementary medicines that are the subject of an interim product licence, the sponsor will need to apply for and obtain a full Agency product licence if they wish to continue to supply the product after the end of the transition period. This application will entail certification that the product labelling complies with Agency requirements and that advertising complies with the Joint Advertising Code. Sponsors will also need to recertify that they hold evidence to support any claims made in relation to the product.
The application fee for converting from an interim product licence to a full Agency product licence will be the same irrespective of whether it is an Australian product simply requiring recertification or whether it is a New Zealand product being regulated for the first time.