EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2013 (NO. 1)
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2013 (No. 1) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of requiring that therapeutic goods that contain ‘Concentrated omega-3-triglycerides - squid’ as a therapeutically active ingredient, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act refer). Medicines are either registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed goods. Part 1 of Schedule 4 does not currently include goods that are oral presentations containing ‘Concentrated omega-3-triglycerides - squid’ as a therapeutically active ingredient.
Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.
If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).
A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5). The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality. The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.
Concentrated omega-3-triglycerides – squid
‘Concentrated omega-3-triglycerides - squid’ is a substance manufactured from body oil obtained from species of squid that are animals of the order Teuthida from class Cephalopoda. This manufacturing process involves the omega-3-acids in the oil being modified in the presence of glycerol, a process known as ‘esterification’, which results in the creation of omega-3-triglycerides.
‘Concentrated omega-3-triglycerides - squid’ is similar in composition to the already permitted ingredient ‘Concentrated omega-3-triglycerides - fish’ and this compositional similarity means the safety of this substance has been established.
In relation to the quality of ‘Concentrated omega-3-triglycerides - squid’, sponsors of goods containing this substance as a therapeutically active ingredient will (unless the Secretary consents otherwise) be required to comply with the monograph in the British Pharmacopeia for ‘Omega-3-Marine Triglycerides’. This monograph has been recently revised to include ‘animals of class Cephalopoda’ as an additional source of omega-3-acids. Previously, the monograph restricted the source of omega-3-acids to fish.
To that end, the delegate of the Minister has determined that therapeutic goods containing ‘Concentrated omega-3-triglycerides - squid’ as a therapeutically active ingredient be included in the part of the Register for listed goods when:
- such goods are for oral use only;
- the ‘Concentrated omega-3-triglycerides - squid’ is obtained from species of the order Teuthida from class Cephalopoda;
- ‘Concentrated omega-3-triglycerides - squid’ is in combination with other ingredients and the preparations are presented in a therapeutic dosage form for therapeutic use; and
- the container, and any other packaging for the goods, is labelled with the warning:
“DERIVED FROM SEAFOOD”.
CONSULTATION
Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry.
The effect of this Listing Notice is that sponsors wishing to use ‘Concentrated omega-3-triglycerides – squid’ in the formulation of a medicine can list the medicine on the Register rather than registering that medicine. Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices (OBPR ref. 14416).
In relation to compatibility with human rights, it is considered that the Listing Notice is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached as Supporting material.