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Listed medicines legislative requirements

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ARGCM Part B: Listed complementary medicines

29 October 2017

This guidance is provided for applicants and sponsors of listed medicines.

Requirements of section 26A of the Act

A medicine is listed on the ARTG on the basis of information provided by the applicant and a certification by the applicant that the goods (that are the subject of the application) meet the requirements of section 26A(2) (a)–(k) inclusive, and if applicable, subsection 26A(3) of the Act. The Act allows for cancellation of a product from the ARTG if the goods are ineligible for listing and a sponsor's certification is incorrect.

Clarification on the requirements of section 26A of the Act is provided below.

The medicine is eligible for listing

Schedule 4 provides conditions that must be met for medicines to be eligible for listing for example:

  • the medicine only contains ingredients and complies with the requirements specified in the Permissible Ingredients Determination
  • the proposed indications are not for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code; and
  • ingredients must not be subject to a Schedule of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) also known as the Poisons Standard.

The medicine is safe for the purposes for which it is to be used

Certain regulatory restrictions and/or controls may be imposed to ensure that the use of a listed medicine is consistent with low risk, for example: label advisory statements, restrictions on dosage and restrictions on route of administration.

You must ensure that you are fully aware of every condition or restriction affecting the use of ingredients in your products so that the product fully complies with all legislative requirements applicable in Australia.

The medicine presentation is acceptable

All aspects of the product are considered to comprise the 'presentation' including:

  • the name
  • indications
  • directions for use
  • warning and cautionary statements
  • packaging
  • dosage form
  • logos
  • symbols and pictures on a medicine label.

Section 3(5) of the Act and 3(A) of the Regulations state when the presentation of a good is considered unacceptable:

Section 3(5) of the Act

For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:

  1. if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or
  2. if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or
  3. if the label of the goods does not declare the presence of a therapeutically active ingredient; or (ca) if the therapeutic goods are medicine included in a class of medicine prescribed by the regulations for the purposes of this paragraph - if the medicine's label does not contain the advisory statements specified under subsection (5A) in relation to the medicine; or
  4. if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or
  5. in prescribed cases.

Regulation 3A of the Regulations: Unacceptable presentations

  1. For paragraph 3 (5) (e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.
  2. For paragraph 3 (5) (e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recovery.

The presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods. Examples of unacceptable presentations include, but are not limited to:

  • Therapeutically active ingredients are present in the formulation but not declared as such on the label (and/or misleadingly declared as 'excipients' in the application).
  • Statements are made attributing a therapeutic role to ingredients that have not been declared as active ingredients, that is: excipient ingredients.
  • Statements or pictures suggest that the product has uses or actions different from, or in addition to, the indications for use included on the ARTG.
  • Presentation of a product is in a form likely to result in its being confused with food, for example: in confectionery-like novelty shapes and packaging.
  • Product names are used that are likely to be misleading as to the composition of the medicine.
  • The appropriate dosage for all age-groups in the likely target population is not stated, for example: 'adults', 'children 6-12 years' etc., as appropriate.
  • The dosage form or directions are inappropriate for the target population, for example: a capsule dosage form is not appropriate for infants.
  • Warning or cautionary statements needed for proper usage of the product are omitted.
  • A reformulated product that does not have labelling adequately informing the consumer that it has different active ingredients from the product previously supplied under that name.
  • Claims are made that a formulation is 'hypo-allergenic' or 'non-irritant', unless the sponsor holds supportive evidence from clinical tests that can be produced on request.
  • Claims are made that a product is free from certain substances, for example: 'free from artificial colours' if not true.

The medicine conforms to every standard applicable

Therapeutic goods must comply with applicable standards before they can be entered on the ARTG. Criminal or civil penalties can be imposed on persons who import, export, manufacture or supply goods that do not comply with applicable standards (unless you have consent to supply such a good under section 14 of the Act - refer to Consent to supply goods not compliant with prescribed standards.

The medicine complies with manufacturing requirements

Australia has codes of good manufacturing practice (GMP) and quality system requirements for the manufacture of therapeutic goods, including complementary medicines. For more information - refer to Manufacturing principles for medicinal products.

In Australia the Act requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence. Where a product is imported, or if any steps in the manufacture of a listed medicine take place outside Australia, the international manufacturer must hold a TGA GMP license, or a license accepted by the TGA - refer to Manufacturing standards for overseas manufacturers.

You must ensure that all the manufacturers of your medicine are included in your product ARTG entry. Use of a manufacturer who is not nominated on the product ARTG entry constitutes an incorrect certification against paragraph 26A(2)(h) of the Act.

The medicine conforms to every requirement relating to advertising

You must ensure that all advertising for the medicine complies with any applicable requirements of Part 5-1 of the Act and the Therapeutic Goods Advertising Code.

The medicine label may not include any claim that is inconsistent with the information included in the ARTG for the medicine and must comply with applicable standards and advertising requirements - refer to Complementary medicine labels.

The medicine complies with all applicable prescribed quality or safety criteria

You, the sponsor, are responsible for the quality of your listed complementary medicine - refer to Quality of listed medicines. You must hold information or evidence to demonstrate that your medicine:

  • complies with all legislative requirements
  • meets all specifications for the shelf life of the medicine, the recommended storage conditions and the expiry date stated on the medicine label.

You are required to certify under paragraph 26A(2)(fc) of the Act at the time of listing that you hold this information. A Delegate of the Secretary can request information or documents about the quality of a listed medicine under paragraph 31(2) (ca) of the Act; and can cancel your listing if they determine that the quality of the medicine is unacceptable.

The sponsor holds evidence to support indications made for the medicine

At the time of listing, the applicant of a listed medicine legally certifies under paragraph 26A(2)(j) of the Act that you hold evidence to support any indication or claim that you make about your medicine. Subsection 28(6) of the Act provides, as a condition of listing, that you must provide this evidence to the TGA if requested to do so. After listing, your medicine may be subject to a compliance review of evidence held by you as part of the TGA's random and targeted post-market monitoring activities or in response to either product safety concerns, or as a result of a complaint about a product.

Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines assist you to determine the appropriate evidence to support therapeutic indications made in relation to your listed medicine.

The information included in the application is correct

You must ensure that the information contained in your application is correct. An incorrect certification against paragraph 26A(2)(k) of the Act could result in the product being cancelled from the ARTG under the provisions of paragraph 30(2)(ba) of the Act.

Conditions of listing

Statutory conditions of listing

Section 28 of the Act provides a number of statutory conditions of listing that automatically apply when your medicine is listed on the ARTG. Failure to comply with a condition of listing may result in the cancellation of the medicine from the ARTG.

General additional conditions of listing

Section 28 of the Act provides legislative powers for the Secretary to impose, vary or remove additional conditions on listed therapeutic goods at the time the medicine is listed, or any time thereafter. There are a number of general 'Additional Conditions of Listing' imposed by the delegate of the Secretary at the time a medicines is listed on the ARTG, which are notified to the sponsor in writing, including the following:

  • The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.
  • The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the TGA, upon request.
  • The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the ARTG.
  • All reports of serious adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the TGA, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the TGA is notified of the report or reports.[3]
  • The sponsor shall not supply the listed medicine after the expiry date of the goods.
  • Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager, TGA, immediately the action or information is known to the sponsor.
  • Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings used in medicines for topical and oral use' as amended from time to time.

Substance specific conditions of listing

Specific conditions of listing may be imposed on a medicine in relation to specific ingredients included in the medicine. These conditions are imposed when the product is listed on the ARTG and are notified to the sponsor in writing. For example, the following condition of listing is imposed on listed complementary medicines that contain preparations of the herbal material, Ginkgo biloba leaf extract:

'The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27). This condition does not apply to powdered or dried leaf'.

Imposition and changes to conditions of listing and sponsor's rights to appeal

Under subsections 28(2B) and 28(3) of the Act, while a medicine is listed on the ARTG, new conditions of listing may be imposed and/or existing conditions may be varied or removed, as determined by a Delegate of the Secretary. A sponsor may also request that a condition of listing be imposed or varied (an application fee may apply) - the Delegate of the Secretary will review the request and sponsors will be advised in writing of the decision.

The imposition or variation of a condition will take effect:

  • on the day on which the notice is given, if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury; or
  • in any other case, on the day specified in the notice, which will be a day not earlier than 28 days after the notice is given.

Sponsors are advised in writing of any conditions of listing and may appeal against a decision to impose, vary or remove a condition of listing. Rights of appeal will be advised in the letter from the TGA imposing the conditions - refer to Appeal mechanisms.


Footnote

  1. The timing of and the type of adverse reactions to be reported are outlined in Australian pharmacovigilance requirements and recommendations for medicine sponsors.