artg listing and ce mark

I just had a bit of quick research into what the latest announcement really means to HepaFat:

Introduction
The Therapeutic Goods Administration (TGA) is a division of the Australian Department of Health and Ageing. Its principal role is as the national regulator of therapeutic goods - a collective term covering medicines, medical devices and some related products. the TGA administers the Therapeutic Goods Act 1989, the objects of which include 'a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia, whether produced in Australia or elsewhere, or exported from Australia'. These activities are fully funded by fees charged for assessments, annual registrations and inspections.

Australian Register of Therapeutic Goods
The lawful supply of any therapeutic good in Australia requires that the product is included on the Australian Register of Therapeutic Goods (ARTG). There are two types of entry on the ARTG. Some products are 'registered' and have an AUST R number on their label. Other products are 'listed' and have an AUST L number. the TGA decides if products are suitable for listing or require registration. Manufacturers are not permitted to suggest or imply in their advertisements that inclusion in the ARTG is a recommendation or endorsement by the TGA.


What is CE Marking (CE Mark)?

CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.

"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.

1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
*Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).

2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.

3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and

4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.


So basically, what I gather from the quick look around that I had, it seems like RHT WASN'T NOT trying hard enough to market HepaFat in the last 6 months, but the fact is, they couldn't do it until we got this ARTG listing and CE marking. "The listing on the ARTG enables Resonance Health to supply HepaFat Scan in Australia and to apply the CE mark, enabling the product to be sold in Europe".

We ready for that snowball that I spoke of? :)