EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2013 (NO. 2)
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2013 (No. 2) (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 ‘squid oil’ 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 containing ‘squid oil’ 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 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 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 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 substance.
Squid oil
‘Squid oil’ is obtained from trimmings of squid (order Teuthida, class Cephalopoda) used in food production. Like many other marine oils, ‘squid oil’ contains omega-3 fatty acids such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The oil is purified and deodorised with the possible addition of suitable antioxidants.
‘Squid oil’ is similar to a range of other permitted marine organism-derived oils, e.g., ‘Fish oil, rich in omega-3 acids’, and this compositional similarity means that the safety of squid oil as a therapeutically active ingredient in listed medicines (subject to the conditions set out in the Listing Notice) is considered to have been established.
To that end, the delegate of the Minister has determined that therapeutic goods containing ‘squid oil’ as a therapeutically active ingredient be included in the part of the Register for listed goods when:
- the preparations are for oral use only;
- the ‘squid oil’ is obtained from species of the order Teuthida of the class Cephalopoda;
- the squid oil is in combination with other ingredients;
- 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”.
As it has been established that the substance is of appropriate quality to allow its use in listed medicines, the TGA has finalised a draft Compositional Guideline in relation to ‘squid oil’. This will be available on the TGA’s website (www.tga.gov.au) for consultation for six weeks following the registration of the Listing Notice. The Compositional Guideline will then be published on the TGA’s website in its final form.
Compositional guidelines are intended to assist applicants for the listing of therapeutic goods in the Register that are goods of a kind described in a listing notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no monograph in the British Pharmacopoeia, United States Pharmacopoeia-National Formulary or European Pharmacopoeia in relation to the ingredient or substance in question.
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 ‘squid oil’ 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 (RIS) 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.