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Third-party retailers are required by law to comply with the TGA Advertising Code 2018 for therapeutic goods.
Our ‘Spectrumceuticals’ brand Company policy
As a practitioner brand, Spectrumceuticals state that third party retailers adhere to the policy that in order to purchase the product, the consumer must sign up to the website and be provided an individual login and password. Further, prior to being able to purchase the product, evidence of being prescribed the product by a healthcare practitioner, or a consultation via a healthcare practitioner through the third-party retailer is required. Under these circumstances, where it is evident on the product webpage that a general consumer cannot purchase the product without signing up and the product is only available if prescribed, compliance with the TGA Advertising Code is not required, providing that there is no information on the product webpage, other than the name of the product in text only, a generic image of a bottle with ‘For practitioner prescribing only’ or similar text on the image, and a purchase price. The price is optional information.
Advertising (including social media, blogs and online shopping carts)
In relation to Spectrumceuticals ‘For Practitioner Dispensing Only’ branded listed medicines, third-party retailers cannot advertise these formulations to the general public via online shopping carts, social media platforms or blogs. We do not endorse advertising in blogs or social media of our Spectrumceuticals brand to patients either.
Only product images supplied by Spectrumceuticals Pty Ltd may be used to display to your registered patients, these images must be current with the applicable ARTG listing and permitted claims. Current images can be obtained via https://spectrumceuticals.com/dropbox-product-images/ (you must be registered on our website as wholesaler to access).
Product descriptions, ingredients, directions for use and permitted indications (claims) can be obtained from each product in our ‘shop’ from the specific ‘TAB’ displayed. This information is always current and compiles with the ARTG listing. Please ensure that you cross reference this information with the Australian Register of Therapeutic Goods (ARTG) https://www.ebs.tga.gov.au/
Product long descriptions, ingredients or indications must not be viewable to the general public other than those on the approved images above. The Spectrumceuticals ‘For Practitioner Dispensing Only’ branded listed medicines may only be sold online if the patient is registered with the third-party retail online shop and can provide proof of a consultation with a practitioner.
Merchandising in physical retail outlet
Within a physical retail outlet, the brand must be positioned on a shelf so that the label cannot be read by the general public. In the case of a refrigerated probiotic formulation, a shelf talker must state that the product is ‘Practitioner Only Not for Retail Sale’ or words to that effect. The product must still be sold only after a consultation and script.
‘For Practitioner Dispensing Only’ products
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.
Responsibility for website information
If the third-party retailer does not maintain the Spectumceuticals range as per the current ARTG listings on their own website, according to the Advertising Code legislation, the retailer is responsible under the law for this content, and if found in breach, will be accountable to the TGA.
If a third-party retailer wishes to provide any further information about a Spectrumceuticals product to the general public other than the product name and supplied product images, they must adhere to the TGA Advertising Code by complying with points 1 to 10 outlined below.
Information if the retailer decides to advertise beyond the Spectrumceuticals Company Policy
Third-party retailers are required by law to comply with the TGA Advertising Code 2018 for therapeutic goods. The TGA document ‘Advertising to the public: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018 V1.2 October 2018 states that:
‘The Code applies to all advertising of therapeutic goods to the public. Advertisements directed exclusively to health professionals (within the meaning of s.42AA of the Act) are not subject to the requirements of the Code. In order for an advertisement to be considered to be directed exclusively to health professionals, the content must not be available to consumers at all.’
‘… the Code applies to any person who advertises, by any means, therapeutic goods; or causes the advertising, by any means, of therapeutic goods to the public. Examples of persons who might advertise, or cause the advertising of, therapeutic goods include the following:
• the sponsor of the goods — i.e. the person in relation to whom the goods are included in the ARTG
• any person in the supply chain for the therapeutic goods (for example manufacturers, wholesalers, retailers, franchisees, multi-level marketers) who advertises the good,’
where ‘the Code’ refers to the Therapeutic Goods Advertising Code 2018.
The TGA Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part A: General guidance on complementary medicine regulation in Australia, under the section ‘For practitioner dispensing only’ products’ states:
‘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.’
Statutory requirements referred to above include compliance to the Therapeutic Goods Advertising Code 2018; ARTG refers to the Australian Register of Therapeutic Goods.
An advertisement for a product that can be purchased directly by a consumer from a website through a ‘buy’ or ‘add to cart’ function or similar, must comply with Section 12 of the Therapeutic Goods Advertising Code 2018, and therefore the following is required on the product webpage:
- The name of the medicine as per the ARTG.
- The name of the dosage form of the medicine as per the ARTG.
- The quantity of the medicine.
- At least one of the indications for the medicine, as the indication appears on the product label (or in the case of practitioner only products that do not have any indications, as it appears on the ARTG).
- A list of ingredients (both as per the TGA Approved Australian Name, and common name if appropriate).
- A statement: ‘Follow the directions for use.’
- If symptoms are included as indications for the medicine – the statement ‘If symptoms persist, talk to your health professional’, or; ‘If symptoms worsen or change unexpectedly, talk to your health professional’, whichever is appropriate as per the TGA Permissible Indications legislation.
- If there are health warnings included in Schedule 1 of the Code, the statement ‘This product may not be right for you. Read the warnings before purchase’ followed by a statement about where the warnings can be found, or a hyperlink to the warnings on the product page.
- The health warnings as per Schedule 1 of the Code.
- If there are no health warnings included in Schedule 1 of the Code – the statement ‘Always read the label’.
Items 6, 7, 8 and 10 must be prominently displayed (as a general rule, this means bold font and located directly above the ‘buy’ or ‘add to cart’ button).
The public ARTG records can be downloaded at the TGA electronic business portal: https://www.ebs.tga.gov.au/
If you have any questions in relation to this communication, please contact us on 1300 852 775