Complementary medicines - permitted ingredients list project
- This consultation closed on 30 April 2004.
The Governments of New Zealand and Australia have signed an Agreement for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products. Subject to the passage of implementing legislation in both countries, a joint agency should commence operations in mid 2006.
The proposed joint agency will regulate the manufacture, supply, import, export and promotion of all therapeutic products, including complementary medicines (eg herbal medicines, traditional medicines, homoeopathic medicines, and therapeutic-type dietary supplements).
A project has commenced to develop a Permitted Ingredients List for low-risk medicines under the joint regulatory scheme. The starting point for developing the list of permitted ingredients will be the list of substances currently permitted to be included in Listed complementary medicines in Australia. In addition, substances contained in New Zealand dietary supplements, but which are not currently 'listable' in Australia, will be identified and a process put in place to evaluate such substances for safety and quality. Substances assessed on the basis of safety and quality as suitable for inclusion in low-risk complementary medicines will be added to the list of permitted ingredients.
For more details about the Permitted Ingredients List project, see below for the text of a letter sent to all manufacturers and distributors of complementary medicines in New Zealand about the Permitted Ingredients List for Low Risk Medicines.
The submission period for notification of ingredients in complementary medicine products has closed.
- Also see: Substances that may be used in 'Listed' medicines in Australia <http://www.tga.gov.au/cm/listsubs.htm>
Letter sent to all manufacturers and distributors of complementary medicines in New Zealand about the Permitted Ingredients List for Low Risk Medicines
17 February 2004
To: All manufacturers and distributors of complementary medicines in New Zealand
JOINT AGENCY PROJECT
PERMITTED INGREDIENTS LIST FOR LOW RISK MEDICINES
The purpose of this letter is to:
- Outline the process for creating a “permitted ingredients list” for low-risk medicines (in particular complementary medicines) under the new joint therapeutic products regulatory scheme; and
- Explain how you can ensure that ingredients used in the products you currently supply are considered for evaluation to determine if they are appropriate for inclusion on the permitted ingredients list.
Background
In December 2003, the "Agreement Between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products" was signed. Subject to the passage of implementing legislation in both countries, the agency will be established and is expected to commence operation in July 2005. At this time, a new regulatory scheme for therapeutic products will come into effect. The agency will regulate the manufacture, supply, import, export and promotion of all therapeutic products, including prescription and non-prescription medicines, complementary medicines and medical devices.
The term “complementary medicine” in this context includes products represented to be for a therapeutic purpose and referred to variously as herbal medicines, traditional medicines (e.g. Chinese, Ayurvedic), homoeopathic medicines, alternative medicines, nutritional supplements (e.g. vitamins, minerals, amino acids) and therapeutic-type dietary supplements.
Under the joint regulatory scheme, a sponsor of a medicine (i.e. the distributor who is legally responsible for the product in the New Zealand market) will be required to hold a product licence in order to manufacture, supply, import, export or promote the product. The process for obtaining a product licence will depend on the level of risk associated with the product and its use.
For those medicines falling into the “low-risk” category, which is expected to include most complementary medicines, the sponsor will be able to go online to complete an application, and the licence will be issued on the basis of the information provided and declarations made by the applicant. This will provide a simple and efficient mechanism for licensing these products, with no delay in getting products onto the market. For these products, the agency will not evaluate individual products prior to issue of a product licence.
For a medicine to be considered "low risk" and therefore qualify for the online licensing process, it will be required to meet certain criteria, including that it contain only ingredients permitted for use in low risk medicines. The agency will maintain a list of permitted ingredients that can be used in low risk medicines (the "permitted ingredients list") and ingredients may be added to the list if, following evaluation of safety and quality, they are considered suitable for use in low risk medicines.
If a medicine contains any ingredients that are not on the permitted ingredients list, the product will not be classed as a low risk medicine and the sponsor will be required to complete an application for evaluation of the medicine by the agency.
A permitted ingredients list for the joint agency needs to be developed prior to commencement of the joint scheme. Australia already has such a list under its current regulatory system, and the substances on that list will be transferred to the new joint agency’s permitted ingredients list. Ingredients in complementary medicines marketed in New Zealand may also be able to be included in the list following an evaluation of safety and quality.
It is proposed that under New Zealand implementing legislation, sponsors of complementary medicines in New Zealand will be required to enter product details on an interim register during the lead-up to commencement of the joint scheme. Products meeting the low-risk criteria will be able to remain on the market in New Zealand for a specified transition period, during which time the sponsor must ensure that all the joint agency requirements (e.g. labelling, GMP) are met, and notify the agency via the online licensing system that this has been achieved. The sponsor will then be eligible to obtain a product licence authorising supply of the product in both Australia and New Zealand.
Products not meeting the criteria for low risk medicines (e.g. products containing any ingredient that is not on the permitted ingredients list) will be permitted to be sold in New Zealand for the duration of a transition period provided that sponsors comply with the transition arrangements. During this time the sponsor will need to submit to the agency product licence applications for evaluation of each product the sponsor wishes to continue marketing.
The evaluation of the safety and quality of ingredients will be carried out as part of the set-up work for the new agency and no application or assessment fee will apply to the sponsor. It is therefore to the sponsor’s advantage to ensure that all ingredients are identified early so that evaluations can be completed and ingredients considered suitable included in the agency’s permitted ingredients list. This will help to ensure a smooth transition to the new scheme, and minimise the number of products for which sponsors are unable to submit product licence applications via the online process.
What is the process for creating the joint agency’s “permitted ingredients list”?
The following process has been designed to enable a permitted ingredients list, containing as many as possible of the ingredients used in products currently marketed in New Zealand, to be developed prior to commencement of the joint scheme in 2005.
Step 1: Identify ingredients in existing products
There is currently no list of ingredients used in complementary medicines supplied in New Zealand. The first step is, therefore, to identify all the ingredients currently in use.
This means that each sponsor will need to provide a list of all ingredients (active ingredients and excipients) used in the products they manufactured or imported and sold in New Zealand during 2003. A form will be provided to help ensure the necessary information is collected in the most useful manner. Information about the trade names or formulations of individual products is not being requested at this stage - just information that will enable accurate identification of the ingredients used.
In addition, sponsors of related products (with consent for distribution under the Medicines Act 1981) should notify Medsafe if they consider that ingredients used in these products may be suitable for inclusion in the permitted ingredients list.
Step 2: Identify those ingredients that require a safety and quality evaluation
Following receipt of the ingredient information, Medsafe will identify those ingredients that are already on the existing Australian list, those that will require a safety and quality evaluation, and those that are known to fall outside the “low-risk” category. The results of this work will be made available to sponsors.
Examples of ingredients that would fall outside the low risk category are ingredients that are scheduled medicines, such as aristolochia or digitalis leaf.
Step 3: Audit of random sample
In order for the process to be equitable, Medsafe will perform an audit of a random sample of ingredients on each list received. Sponsors will be asked to provide evidence that products containing these ingredients were actually sold in New Zealand during 2003. Acceptable evidence can include documents such as manufacturing records, import certificates, sales invoices or shipping orders.
Step 4: Carry out safety and quality evaluations
The required evaluations will be done as part of the joint agency set-up process. Sponsors will not be required to compile applications or to pay fees.
Evaluations will be performed by a team of evaluators who are appropriately qualified in toxicology, pharmacology and herbal medicine, and referred to an appropriately constituted expert committee before decisions are made about the suitability of ingredients.
What do you need to do?
To ensure that the ingredients in your products are included in this process, you will need to compile a list of all ingredients included in products you are currently manufacturing or distributing in New Zealand, and declare that these ingredients are present in products that have been manufactured, imported or sold in New Zealand during 2003. Industry associations have agreed to collate lists from their members and forward a consolidated list to Medsafe.
If you have received this list from your industry association, please send your list to that association and not to Medsafe. If you do not belong to an industry association, you may send your list directly to Medsafe. The form is available through the Medsafe website and can be transmitted electronically. Alternatively, lists being provided directly to Medsafe can be posted to:
Khay Ooi
Permitted Ingredients List Project
Medsafe
PO Box 5013
Wellington
Please do NOT send your list to both your industry association and to Medsafe.
In order for a ‘master’ list of ingredients to be compiled and for evaluation work to begin as soon as possible, we need to receive the ingredient information by 30 April 2004.
What will happen next?
When the ingredient lists have been processed, Medsafe will make available a list of ingredients that will require a safety and quality evaluation. These evaluations will then be carried out and those ingredients identified as suitable for use in low risk medicines will be recommended for inclusion in the joint agency’s permitted ingredients list.
Note: The joint agency permitted ingredients list will not be approved or take effect until commencement of the joint scheme.
What can you do to help other complementary medicine sponsors?
Because there is no complete list of complementary medicine products or distributors in New Zealand, there is no certainty that we have been able to contact everyone who distributes these products. If you are aware of others who are manufacturing or distributing complementary medicines and may not have received this letter (e.g. individuals or small companies that may not be members of an industry association), please pass this information on to them.
Yours sincerely
Susan Martindale
Team Leader, Business Development and Support