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Guide to the completion of the 'Notification of selective non-disclosure of Active Herbal Extract details' form

Version 3.0, March 2015

25 March 2015

Introduction

This guidance document has been developed to assist sponsors of therapeutic goods and suppliers of Active Herbal Extracts when completing the 'Notification of selective non-disclosure of Active Herbal Extract details' form. This form should be used to request the TGA not to disclose certain details regarding an 'Active Herbal Extract'—for example, solvent type, concentration extract ratio and extract excipient details—to the sponsor. Please note that information such as herb species, plant part, basic preparation details—for example, concentrated extract—ratio of equivalent dry weight to extract amount, and component percentage (if relevant) can be disclosed.

The Act requires that therapeutic goods supplied in Australia, unless specifically exempted or excluded, be registered or listed on the Australian Register of Therapeutic Goods (ARTG), before they can be supplied in, or exported from, Australia.

Information supplied to the TGA in relation to the inclusion of an Active Herbal Extract on the ARTG that is not in the public domain may be treated as commercially confidential information.

Such information will be treated appropriately by the TGA. Information about this treatment can be found as follows:

Disclaimer: It is the responsibility of the sponsor of a medicine including an 'Active Herbal Extract' in their formulation to ensure that the permitted herbal ingredient, after undergoing a specific manufacturing process, complies with the definition of a herbal substance (defined in Regulation 2 of the Therapeutic Goods Regulations 1990). Sponsors are reminded of the importance of ensuring the correctness of matters which they must certify under subsection 26A of the Therapeutic Goods Act 1989 in relation to their medicine containing an Active Herbal Extract. These include that the medicine is safe for the purpose for which it is to be used, that it conforms to all applicable standards and is eligible for listing.

Regulation 2 of the Therapeutic Goods Regulations 1990 (the Regulations) includes the following definition:

herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):

  1. that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and
  2. that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.

Disclaimer: It is the responsibility of the sponsor of a medicine to be aware of any restricted ingredients contained in the 'Active Herbal Extract' by obtaining this information from the Active Herbal Extract supplier.

Regulation 11 of the Regulations state that:

A substance is a restricted ingredient if:

  1. it is an ingredient in a relevant medicine; and
  2. for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:
    1. Schedule 4;
    2. the Poisons Standard;
    3. a condition imposed under section 28 of the Act;
    4. a standard under section 10 of the Act;
    5. the Required Advisory Statements for Medicine Labels;
    6. any other provision in these Regulations or in the Act that deals with eligibility of medicines for listing.

'Active Herbal Extract' suppliers should note the following:

  • It is the supplier's responsibility to provide complete and accurate formulation details about their Active Herbal Extract.
  • It is the supplier's responsibility to advise the TGA, and sponsor(s) using their Active Herbal Extract, of any change in formulation, Active Herbal Extract name, supplier or supplier details.

Sponsors and other users of Active Herbal Extracts should note the following:

  • The allocation of a specific name and reference number to an Active Herbal Extract by the TGA is not related to any evaluation, approval or similar in relation to the extract. It is solely a mechanism to assist in having an efficient application process for new listed medicines. The TGA is aware that claims have been made that the allocation of this number constitutes an endorsement by the regulator, however this is not the purpose of the allocation.
  • The inclusion of an Active Herbal Extract in the ARTG does not imply any recommendation for its use in either registered or listed medicines or medical devices.
  • It is the sponsor's responsibility to ensure that the correct Active Herbal Extract information—for example, the name and number, is provided to TGA in their product formulation.

Definition of an Active Herbal Extract

An 'Active Herbal Extract' for the purposes of this document, is a herbal extract or concentrate for which a supplier intends specific information on the extraction method, steps and/or solvent details, that is not to be disclosed from sponsors who include the extract as an active ingredient in a listed medicine. An Active Herbal Extract contains a single herbal active ingredient and may or may not contain excipient ingredients.

All ingredients included in the formulations of Active Herbal Extracts must be permitted for use in listed medicines.

All ingredients (active and excipients) must use valid names consistent with the TGA approved terminology for medicines. Quantitative data must also be provided for all ingredients. Note that the name of the active ingredient in an Active Herbal Extract can be disclosed, in accordance with the Act.

Form layout

The 'Notification of selective non-disclosure of Active Herbal Extract details' form consists of the following two parts:

TGA processing of the form

A 'Notification of selective non-disclosure of Active Herbal Extract details' form must be submitted to the TGA by the supplier of the Active Herbal Extract, or an agent acting on behalf of the supplier of the Active Herbal Extract. However, the sponsor of the finished product may submit this form on the supplier's behalf, provided a letter of authorisation from the supplier is enclosed with the notification.

When a 'Notification of selective non-disclosure of Active Herbal Extract details' form is lodged with the TGA, the following processing steps occur:

  • The form is checked to ensure that all required information has been provided, including that all ingredient names are in the required format.
  • The eligibility of the Active Herbal Extract is established—all active and excipient ingredients are checked to ensure that they are permitted for use in listed medicines.
  • If all ingredients are permitted for use in listed medicines, the notification will result in the standardised/non-standardised extract being allocated a specific name and Active Herbal Extract reference number and entered into the eBusiness Services (eBS). The name and reference number will be used in listed medicine entries on the Australian Register of Therapeutic Goods (ARTG) entries.
  • A letter is sent to the Active Herbal Extract Ingredient supplier (and sponsor, if nominated), advising of the Active Herbal Extract name, number and supplier's name. Sponsors who wish to include an Active Herbal Extract in an application to list a product on the ARTG require this information. The Active Herbal Extract used in a product must match the information supplied by the supplier in their notification to the TGA.

Non-acceptance of the form

The TGA will not accept an Active Herbal Extract notification if:

  • Any of the active or excipient ingredients are not permitted for use in listed medicines
  • Any of the active or excipient ingredient names nominated for the Active Herbal Extract are not in an AAN format
  • The Active Herbal Extract contains more than one herbal active ingredient or a non-herbal active ingredient
  • The Active Herbal Extract includes another proprietary ingredient, or
  • Any request to a supplier for clarification for an Active Herbal Extract is ignored or the information supplied is such that the Active Herbal Extract is still unable to be finalised.

Public disclosure of information

Suppliers should be aware that the following information regarding Active Herbal Extracts is available to third parties:

  • The Active Herbal Extract name, number, supplier name and supplier's client detail number.
  • Details of the active ingredient, including herb species, plant part, basic preparation details (for example, concentrated extract), ratio of equivalent dry weight to extract amount and component percentage.
  • The active ingredient can be disclosed in accordance with the Act, but selective information on solvent and extraction methods will usually be commercially confidential information. Information on an active ingredient is in the public domain and must be displayed on the label in accordance with the Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69). All active ingredients, regardless of the source of these ingredients (chemical, biological or herbal), must be displayed on the label of a medicine.
  • The name and quantity of any restricted ingredients. The supplier is responsible for disclosing to the sponsor any restricted ingredients contained in the Active Herbal Extract.
  • Compliance with relevant Regulations or Therapeutic Goods Orders (TGOs). The requirements for public disclosure of excipient ingredients or active ingredients are contained in:
    • Schedule 1 of TGO 69, which lists 'Excipients required to be declared on the label of medicines'. This includes ingredients such as ethanol, hydroxybenzoic acid esters, peanut and peanut products and sodium salts.
    • Item 3(2)(b) of TGO 69 'Particulars to be included on a label', which states that the name(s) of all active ingredients in the goods must be stated on the label.

Section 46 of the Regulations 'Release of information', which states that the information which can be released to the public are the name and quantities of therapeutically active substances in the good, and/or the presence or absence of any specific excipient in the goods.

Specific instructions for completing the 'Notification of selective non-disclosure of Active Herbal Extract details' form

Questions 1-11 are to be completed by the supplier of the Active Herbal Extract, or an agent acting on their behalf. Where an agent is acting on behalf of a supplier, an agent sponsor relationship must exist on the TGA's Client database. Where the relationship has not been established, a completed 'Client details' form must be submitted with the notification.

A sponsor using the Active Herbal Extract in a finished product may submit a 'Notification of selective non-disclosure of Active Herbal Extract details' form on the supplier's behalf, provided a letter of authorisation from the supplier is enclosed with the notification.

Where an agent submits a notification on behalf of a company that is registered solely as a manufacturer on TGA's Client database, a letter of authorisation from the manufacturer should be enclosed with the notification, giving their permission for the TGA to communicate with the agent, on matters relating to the notification.

Part A - General details

1 Active Herbal Extract Supplier's Business name:

Provide the full name of the person or corporation that supplies the Active Herbal Extract. This must be identical to that supplied in the 'Client details' form. A completed 'Client details' form must be submitted with this notification unless one has already been submitted and there have been no changes to the information contained in that form (including authorised contacts for the organisation).

The name of the person or corporation supplying the Active Herbal Extract may include the trading name, but must include either:

  • the registered company name under the companies code, if the supplier is an Australian company, or
  • the equivalent company name registered under overseas legislation, if the supplier is an overseas company, or
  • the name of the person who conducts the business.

Provide the supplier's business name as follows:

  • for corporations: the registered company name—for example, Wonder Herbs Australia Pty Ltd
  • for individual traders: the full name of the person conducting the business—for example, John Canberra Smith
  • for partnerships: the full names of all partners—for example, John Canberra Smith and Mary Melbourne Brown, or
  • if trading under another business name: if appropriate, give any other trading name or abbreviated name in brackets after the above name—for example, John Canberra Smith (Wonder Herbs), or International Wonder Herbs (IWH).
2 Active Herbal Extract Supplier's Business address:

Provide the postal address of Active Herbal Extract supplier.

3 Active Herbal Extract Supplier's Client Identification (ID) number:

Provide the supplier's Client Identification (ID) number if known. If the supplier does not have an ID number, please leave this Item blank and complete and submit a 'Client details' form with this notification.

4 Active Herbal Extract Supplier's Contact officer:

Provide the name of the person who is acting on behalf of the supplier and to whom any correspondence should be referred. This person should be an authorised contact for the organisation, with details included on the TGA's Client ID database.

Contact details such as postal address, e-mail address (if available), phone number and/or facsimile number should be provided, except where Item 3 has been completed.

5 Have you attached a completed 'Client details' form for this information?

To obtain a 'Client details' form please contact the eBusiness Services by telephone on 02 6232 8888 or refer to Business services: getting started with TGA.

Additional information regarding client details:

The TGA requires accurate information regarding your postal and street addresses, e-mail addresses (if available), telephone and fax numbers and the persons to contact regarding the 'Notification of selective non-disclosure of Active Herbal Extract details' form that you have submitted. A separate 'Client details' form should be used to provide this information. You do not need to complete this form if the TGA already holds current information for your company and all authorised persons.

If your contact details change, please advise the TGA of such changes as soon as possible, by submitting a new 'Client details' form.

6 Active Herbal Extract Manufacturer's Client Identification (ID) number:

Provide the Manufacturer's Client ID number, if known.

If you have not been allocated a Client ID number, leave this question blank and either complete and submit a separate 'Client Details' form, or ensure Item 7 is completed in full.

If you do not know your 'Client ID' number, please contact the Active Herbal Extract Coordinator by phone on +61 2 6289 4627 for further information.

7 Active Herbal Extract Manufacturer's name and site ddress

Where Item 6 has not been completed, please provide the name and site address of the manufacturer. Please include all manufacturers if there is more than one manufacturer.

Part B—Product/ formulation details

8 Proposed Active Herbal Extract name:

The Active Herbal Extract name is the name (proprietary or trade name) of the Active Herbal Extract supplied in Australia. State the Active Herbal Extract name exactly as the supplier has stated or as the name appears on the product label or product specification sheet. The Active Herbal Extract name must also include the botanical name (Genus, species) of the active herbal ingredient—for example, Ginkgo biloba. This must be an Approved Herbal Name (AHN), as listed in the TGA approved terminology for medicines.

There are some computer limitations which should be considered in the naming of an Active Herbal Extract, such as:

  • the maximum length of a Active Herbal Extract name available in eBS is 150 characters
  • the use of certain punctuation symbols—for example, comma and full stop - is limited because the computer system cannot search on these symbols
  • words or symbols related to trademark or copyright are not to be included in the PI name
  • eBS will not accept duplicate names for an Active Herbal Extract. Therefore, if there is a change in the formulation of an Active Herbal Extract, a new number is required. As such, the name must be modified to allow the new formulation to be entered on the database.
9 Please supply the following information for the active ingredient:

The following information must be provided for the active ingredient in the Active Herbal Extract.

  • Botanical name:

    Please provide the botanical name (Genus, species) of the active herbal ingredient—for example, Ginkgo biloba. This must be an Approved Herbal Name (AHN), as listed in the TGA approved terminology for medicines. The herbal ingredient must be permitted for use in listed medicines.

  • Plant part used:

    The plant part nominated must use botanically correct terminology and must use an appropriate Australian Approved Name (AAN), as listed in the TGA approved terminology for medicines. Examples of plant-part AANs include 'leaf', 'stem bark' and 'whole plant'.

  • Type of preparation:

    Details of the plant preparation should accurately describe the preparation used. The preparation must be a Preparation AAN as listed in the TGA approved terminology for medicines—for example, 'extract dry concentrate'.

  • Equivalent weight of herb (specify fresh or dry):

    Where the substance is processed, the equivalent dry or fresh weight of the herbal material should be provided.

  • Standardised activity:

    If the active herbal ingredient has been standardised to a herbal component, either a single chemical entity or a component group, this must be nominated, using an approved Herbal Component Name (HCN) as listed in the TGA approved terminology for medicines - for example, 22% theanine. It may be necessary to apply for a HCN if one is not available.

    If the standardised quantity is expressed as a minimum—for example, 'not less than 20% theanine', this value will be entered.

    If the standardised quantity is expressed as a range, the midpoint of the range will be selected to express the quantity—for example, if the standardised component is 20-24% theanine, this will be expressed as 22% theanine. In some cases suppliers may not wish to use the midpoint value. If this is the case, please contact the Complementary Medicines Branch by phone on +61 2 6289 4627 for further information.

  • Equivalent amount of standard component (specify in mg/g):

    The quantity of the standardised active component(s) must be stated—for example, equivalent cascaroside A 240 mg/g.

  • Native plant/ Extract ratio:

    The native plant/ extract ratio is to be stated. This is the ratio of the weight of herbal material in a given amount of the final extract, to the weight of herbal material initially used to make that amount of extract (this is sometimes called the 'native extraction ratio').

  • Final plant/ Extract ratio:

    The final plant/ extract ratio is to be stated. This is the ratio of the weight of the final amount of extract used, to the weight of the dried herbal material used to make this amount of extract. This may be the same as the native plant/ extract ratio if there are no excipients included in the final extract.

  • Details of each extraction step used in the Active Herbal Extract (Please note that this should only include solvents that are used to obtain the extract, not those solvents used in other roles in the manufacturing process):

    The name and relative proportion of solvent(s) used in each extraction must be provided. The solvent must be in AAN format or an accepted abbreviation (but written at least once in full) and approved for use as a solvent in products on the ARTG. The relative solvent concentrations should be stated as percentages. If there is more than one solvent the percentage figure refers to the proportion of the first named solvent. For example, one solvent "in 100% Water", or two solvents "in 45% Ethanol:Water". For more information refer to 'The extraction Ratio—AAN and Solvent - AAN' in the TGA approved terminology for medicines.

    If there is more than one extraction step in the processing of the herbal material, the extraction ratios of the weight of the raw herbal material should be provided for each extraction step - for example:

    1. Extract (5:1) in 40% Ethanol:Water (E:W)
    2. Extract (10:1) in 100% glycerol.

    If the active ingredient has more than six extraction steps, please copy the relevant page and attach to the 'Notification of selective non-disclosure of Active Herbal Extract details' form as part of your application.

Please note that solvents that are used in the manufacturing process, but do not affect the final extraction ratio should not be included as an 'extraction step'. For example, some manufacturing processes involve use of an organic solvent to 'wash' the dried native extract; this solvent is then removed before addition of excipient ingredients and preparation of the final extract. In this instance, only the solvent used to obtain the native extract would be identified in the notification form.

10 Please list all the excipient(s) used in the formulation, including the quantity of each ingredient expressed as a percentage. Attach additional pages if required:

Each excipient ingredient must be listed and the amount must be nominated. All excipient ingredients must be in AAN format and permitted for use in listed medicines. State the quantities of each excipient ingredient as a percentage (w/w).

If the Active Herbal Extract contains more than ten excipient ingredients, please copy the relevant page and attach to the 'Notification of selective non-disclosure of Active Herbal Extract details' form as part of your application.

11 Total number of ingredients contained in the Active Herbal Extract formulation:

Include the total number of ingredients in the Active Herbal Extract formulation.

More information

For further assistance, please contact the Complementary Medicines Branch by telephone on +61 2 6289 4627.


Version history
Version Description of change Author Effective date
V1.0 Original Publication. Office of Complementary Medicines October 2010
V2.0

New title for the Application form. Changes to Part A, B and C of the form and in the guidance document resulting in a more streamlined process for processing notifications of Active Herbal Extracts (AHEs); the TGA will not assess AHEs for compliance with the definition of a 'herbal substance', but will use the information provided in the notification form to ensure that all ingredients are permitted for use in listed medicines.

Office of Complementary Medicines February 2013
V3.0

Commercially confidential updates

Table of contents updated

Hyperlinks updated

Updated Branch name

Principal Legal Advisor, Regulatory Operations Unit March 2015