Practitioner Definition

Rener Health Products stocks a range of products to supply a whole range of modalities, some of which are designated: PRACTITIONER ONLY. In order to be able to access supply of Practitioner Only products, or even 'advertising' such as manuals, product information, access to training seminars etc. you MUST have completed 'tertiary equivalent' training in an ORAL MODALITY (or ingestible modality) from a recognised educational institution.

Such qualifications as medical practitioner, chiropractor, naturopath, herbalist, TCM practitioner, homeopath, clinical nutritionist, osteopath, vet, dentist, registered nurse (midwife) etc, generally means access is available to such products. To be eligible to purchase Practitioner Only lines and information, you MUST be a current financial member of your professional association. Most associations will have provided you with a TGA Exemption Certificate - a copy of which should be forwarded to our office to have on file should we be audited (this should be updated yearly). If no such certificate is issued, then a copy of your qualification/academic record proving eligibility should be forwarded to our office, or a copy of your current membership certificate of your professional association (this latter option should be updated yearly).

As distributors we have an obligation to adhere to these requirements and can be penalised where a breach of the Act has occurred. It is in both our interests to ensure simple bureaucratic requirements are met - this should also be followed for all your suppliers of Practitioner Only products! You should also be aware that there are some restrictions to displaying, advertising, and dispensing Practitioner Only goods which are explained in the next section.


TGA Requirements for Practitioners

The THERAPEUTIC GOODS ACT (TGA) demands that we only provide information to practitioners who are exempted in Regulation 4 of the Therapeutic Goods Regulations. Information and advertising includes labels, catalogues, and other advertising material concerning products which are designated as Practitioner Only (this extends to seminars, manuals, and supply of product as we understand it).

PERSONS LISTED BELOW ARE EXEMPT FROM ADVERTISING RESTRICTIONS:

Herbalist, Homoeopaths, Naturopaths, Nutritionists, Practitioners of Traditional Chinese Medicine, Osteopaths registered under a law of State or Territory, Chiropractors, Medical Practitioners, Pharmacists, Dentists, Veterinary Surgeons, Nurses, Physiotherapists, Biomedical Engineers, Medical Scientists in accredited laboratories, Purchasing Officers in hospitals, or other health care professionals who are engaged in the business of purchasing wholesale therapeutic goods.

PERSONS WHO ARE MEMBERS OF AN AUSTRALIAN BRANCH OF ONE OF THE BODIES BELOW ARE ALSO EXEMPT FROM ADVERTISING RESTRICTIONS:

Acupuncture Association of Australia
Acupuncture Ethics & Standards Organisation
Assoc. of Traditional Health Practitioners Inc.
Aust-China Acupuncture & Chinese Medicine Assoc. Inc.
Australasian Federation of Natural Therapists Inc.
Australian Acupuncture Association Ltd
Australian Association of Ayurveda
Australian Association of Exercise & Sports Scientists
Australian Association of Professional Homoeopaths
Australian Committee of Natural Therapies Inc (SA)
Australian Federation of Homoeopaths
Australian Federation of Homoeopaths (Qld) Inc
Australian Federation of Homoeopaths (WA) Inc
Australian Natural Therapists Association Ltd
Australian Naturopathic Practitioners & Chiropractic Assoc.
Australian Society of Homoeopaths Inc
Australian Traditional Chinese Herbalists Association (Qld)
Australian Traditional Chinese Herbalists Association Inc
Australian Traditional Medicine Society
Chinese Medicine Association Pty Ltd
Chinese Medicine Association of Australia Inc
Complementary Medicine Association
Fed. of Chinese Medicine & Acupuncture Societies of Aust.
Homoeopathic Education & Research Association
International Association of Trichologists
International Christian Association of Natural Therapists Ltd
National Herbalists Association of Australia
Naturopathic Physicians Association of Australia Inc
Queensland Naturopathic Association Register of Acupuncture & Traditional Chinese Medicine
Society of Natural Therapists & Researchers Inc
Society of Classical Homoeopathy Ltd
Traditional Medicine of China Society Australia
Society of Chinese Medicine & Acupuncture (Vic) Inc
Naturopathic Practitioners Association Inc
The Acupuncture Assoc. of Australia, New Zealand & Asia
The Alumni Assoc. of Natural Medicine Practitioners Inc
The Australian Podiatry Association (NSW)
The New South Wales Research Association of Traditional Chinese Medicine

If in doubt, please contact your professional association or the TGA website: http://www.tga.health.gov.au/

We would appreciate that you keep us updated as to your professional status, particularly if there is a change that affects our ability to further supplies of Practitioner Only products or materials to you.

The rules and regulations that govern your requirements in dispensing, storing, and accessing Practitioner Only lines are a complex mixture of Therapeutic Goods Act (TGA) Regulations, Professional Indemnity insurance requirements, your Professional Association's requirements, and marketing policy of the 'sponsor' company (the company that manufactures the product and owns the brand).

The reasons Practitioner Only products are licensed as just that are equally many and varied. Some companies are just primarily 'professional focussed' and produce formulae aimed at fulfilling a clinicians requirements - these may well be uneconomic to promote via retail channels. Sometimes particular ingredients or formulae are made at such strength or include such ingredients that to place them in the hands of the unskilled would simply be 'dangerous'. Whatever the reason, there are certain 'rules of engagement' that need to be clearly understood.

To make things comprehensible and to keep 'rules' fairly simply and general, we suggest you follow the following guidelines at all times:

  • Practitioner Only products are to be kept AWAY FROM PUBLIC ACCESS at all times. For a Practitioner this means having a dispensary excluded from public access or keeping goods inside the consulting room, preferably in a lockable cabinet or where the door can be secured. In more open areas or where access is harder to control, we suggest keeping goods behind a counter or reception desk that is manned at all times during trading hours.
    Practitioner Only products should ONLY be dispensed where a professional consultation (or prescription) has been acquired and displayed to whoever 'fills the script'.
  • Certain 'retail' establishments are entitled to receive Practitioner Only products provided that a suitable person prescribes the goods (a TGA Exempt Practitioner) and conducts 'consultations'. We suggest you contact both your professional association and your professional indemnity insurer to clarify these issues as they differ from one to another. An example where this is feasible would be a pharmacy being a 'pick up point' for a consulting medical practitioner, naturopath, or other health professional.
  • Full patient records should be kept by the prescriber of the Practitioner Only product and, where possible, records of 'repeat supply' should be noted. Such 'individual mixes' as herbal or homoeopathic blends should be kept in a register with appropriate details - again consultation with your professional association and insurer should clarify your requirements.
  • If goods are kept in a 'public access environment' (such as retail store acting as pick up point, conducting consultations at expos etc., or employing Health Professionals in retail stores to conduct health consultations) , they must ALWAYS be kept out of public reach - we suggest behind a 'manned' counter or in a consultation room.
  • Ethically speaking (and this is a definitive requirement of some professional associations) consultations should be as 'complete' as possible and should be conducted in an environment where privacy and patient confidentiality may be maintained - this requires purpose built consulting rooms and waiting room be made available.
  • A sound knowledge of products and ingredients means more successful patient outcomes and less likelihood of negative reactions. Attending seminars, furthering education, having complete patient history, a complete knowledge of patient's current 'drug-taking' (inc. recreational, prescribed allopathic medication, and other nutritionals/herbals) are all required to minimise negative legal exposure and maximise potential therapeutic effect.

None of the above information replaces your own legal and ethical requirements. Please consult your professional association (representative body) or your professional indemnity insurer to clarify any issues you don't understand. The above is only meant as a guideline and is based on our own understanding of the law both as a supplier and as clinical manager. The rules and guidelines change from profession to profession and association to insurer but, with litigation in our industry on the rise, it would be wise to remain as informed as possible - seek professional advice.

Please also note that similar restrictions are placed on Practitioner Only goods' advertising. If you plan to put an ad or 'product shot' in a newspaper etc., you need to obtain prior approval - the following excerpt from an email rec’d explains it: TGA requires all advertisements or advertorials for products used on or in the body to have a CHC number or an ASMI number to show they have been cleared by the Complimentary Health Care Council or Australian Self Medication Industry. Advertisements for Therapeutic Goods must not appear without one of these numbers. If in doubt, consult a professional.