Earth Angel, i was intrigued by your post regarding...

Earth Angel, i was intrigued by your post regarding complementary products:

Complementary medicines are non-prescription medicines available from health food shops, supermarkets and pharmacies. Most of these medicines are available for purchase on the shelf for consumers to select, unlike prescription medicines (prescribed by a doctor) and some OTC medicines (selected by a pharmacist).

Complementary medicines should not replace medical treatments recommended by healthcare professionals.Some examples of complementary medicines include:

• traditional herbal medicines
• some nutritional supplements
• vitamins and minerals
• homeopathic (diluted) preparations
• aromatherapy preparations including essential oils
• traditional Chinese medicines
• Ayurvedic (traditional Indian) medicines.

Most complementary medicines must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be sold in Australia.There are three types of complementary medicines:

• listed complementary medicines, which have an AUST L number on the label
• assessed listed complementary medicines, which have an AUST L(A) number on the label
• registered complementary medicines, which will have an AUST R number on the label.

Listed medicines and assessed listed medicines are usually chosen by the consumer, rather than prescribed or recommended by a doctor or pharmacist. Almost all complementary medicines are listed.

Registered medicines are higher risk, and while some are able to be chosen by the consumer, some are only available through a health professional.Listed complementary medicinesListed complementary medicines are lower risk, so are not assessed for efficacy before going on sale.

When a sponsoring company lists a medicine on the ARTG, they must declare that the medicine:contains only pre-approved low risk ingredientsmakes only pre-approved low risk health claimsis supported by evidence that the sponsor of the medicine holdsis manufactured at a licensed Australian site, or at an approved overseas facilitycomplies with all other regulation, such as the Therapeutic Goods Advertising Code

I have highlighted the interesting take-aways from the TGA extract above. It would seem that there is an alternative pathway to the market for Nasodine. FRE cannot go down the assessed route yet as assessed listed medicines undergo an efficacy assessment before going on sale.

This would enable FRE to initially go to market with Nasodine as a "Listed Complimentary Medicine" bringing in revenue and allow them to pursue the "Assessed Listed Complimentary Medicine" approvals at a later date.