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Complementary medicine practitioner medicines and exemptions
ARGCM Part A: General guidance on complementary medicine regulation in Australia
The TGA does not regulate health practitioners, we regulate therapeutic products. The Australian Health Practitioner Regulation Agency (AHPRA) is responsible for the implementation of the National Registration and Accreditation Scheme across Australia. Currently, only Chinese medicine practitioners are registered with the AHPRA.
In April 2015, Health Ministers agreed to the terms of the first National Code of Conduct for health care workers detailed in the COAG Health Council's Final Report: A National Code of Conduct for health care workers. The National Code, once implemented, will set minimum standards of conduct and practice for all unregistered health care workers. It will also set national standards against which disciplinary action can be taken including the issuing of a prohibition order.
There are a number of specific provisions in the Act which provide exemptions from the operation of certain parts of the Act, for example: the requirement for specific therapeutic goods to be included on the ARTG; the requirements for specific therapeutic goods to be manufactured under GMP; and advertising exemptions.
Exemptions for extemporaneously compounded and dispensed complementary medicines
Schedule 5, Item 6 of the Regulations provides exemption from inclusion on the ARTG for medicines that are dispensed or extemporaneously compounded by practitioners.
Schedule 8(4) of the Regulations provides an exemption for specified complementary medicine practitioners from the operation of Part 3-3 of the Act (Manufacturing of therapeutic goods) and therefore the requirement to manufacture certain medicines under GMP:
where the preparation is for use in the course of his or her business and:
- the preparations are manufactured on premises that the person carrying on the business occupies and that he or she is able to close so as to exclude the public; and
- the person carrying on the business:
- supplies the preparation for administration to a particular person after consulting with that person; and
- uses his or her judgement as to the treatment required.
The exemptions relating to extemporaneous compounding and dispensing apply where a health practitioner prepares a medicine for an individual patient either following consultation with that particular patient, or to fill a prescription for that particular patient. This allows health practitioners such as pharmacists, herbalists, naturopaths, nutritionists and homoeopaths, to prepare medicines for individual patients that do not need to be assessed or evaluated by the TGA for quality, safety or efficacy. The exemption recognises the one-off nature of such medicines and the professional training of the health practitioner to prepare a medicine for the specific needs of an individual patient.
Most herbal ingredients may be used for preparing medicines that are dispensed or extemporaneously compounded. However, access to some medicinal ingredients is restricted by State and Territory drug and poisons legislation. Depending on the level of access control, some ingredients are not available for dispensing or extemporaneous compounding by health practitioners, such as: ingredients included in Schedule 4 of the Poisons Standard which are available only on prescription from a practitioner registered under a law of a State or Territory.
Pre-packaged (manufactured) medicines made by practitioners
The exemption for extemporaneously compounded medicines does not cover situations where a health practitioner makes up medicines in advance, in anticipation of patients who may come onto the premises and ask for that medicine.
Ingredients that are either pre-packaged for other therapeutic purposes or formulated as a dosage form are subject to assessment for quality, safety and efficacy as appropriate, and are to be included on the ARTG. Unless exempt, medicines included on the ARTG need to be prepared by a person in accordance with Good Manufacturing Practice.
'For practitioner dispensing only' products
Sponsors may choose to supply their products in a dispensing pack solely to healthcare practitioners with the words 'for practitioner dispensing only', or words to that effect, included on the label. These medicines must meet the same statutory requirements relating to entry on the ARTG. This includes that labelling (apart from indications) must meet the requirements of the Therapeutic Goods labelling Order and the Therapeutic Goods Advertising Code (unless the appropriate exemption or approval to do otherwise has been granted).
Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) commenced on 31 August 2016 and has a 4 year transition period. During this time, complementary (non-prescription) medicines must comply with either TGO 92 or Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69). Sponsors must specify which order they are compliant with. On and from 1 September 2020, these medicines must comply with TGO 92.
The only difference between 'for practitioner dispensing only' products and other listed or registered complementary medicines is that the former do not need to include a statement of their purpose/ therapeutic indication on the label [refer to TGO 69 Section 3(2) subsection (m) or TGO 92 Section 8(1)(n)]. These medicines should only be supplied to an individual after consultation with a healthcare practitioner, at which time, the healthcare practitioner attaches a label to the medicine providing instructions for use for that individual.
Exemptions for advertising directed to health professionals
Section 42AA of the Act provides for sponsors to advertise directly and exclusively to health professionals advertising material that is exempt from complying with the advertising requirements in the Act and the Regulations. Section 42AA of the Act also exempts those health professionals from the advertising rules when they give advice to their patients.
Some health professional associations provide their members with 'Therapeutic Goods Advertising exemption certificates', advising the member they may receive advertising material from sponsors that are exempt from complying with usual advertising requirements. Note that such certificates are not issued by the TGA.
Advertisements for therapeutic goods directed exclusively to healthcare professionals are governed by industry codes of practice and are not subject to the Therapeutic Goods Advertising Code. For more information, please refer to the CMA Codes of Practices on the Complementary Medicines Australia website and the Australian Self Medication Industry (ASMI) Code of Practice.