ATTACHMENT

 

Details of the Therapeutic Goods Amendment (Listed Medicines) Regulation 2015

 

Section 1 - Name

This section provides for the Regulation to be referred to as the Therapeutic Goods Amendment (Listed Medicines) Regulation 2015.

 

Section 2 - Commencement

This section provides for the Regulation to commence on 1 January 2016.

 

Section 3 - Authority

This section provides that the Regulation is made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 - Schedule

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedule 1 - Amendments

 

Item 1 - At the end of regulation 3AA

Item 1 inserts an additional paragraph in regulation 3AA of the Therapeutic Goods Regulations 1990 (the Principal Regulations) which has the effect of excluding the following class of medicines from the requirement to include on the label advisory statements set out in a legislative instrument made under subsection 3(5A) of the Act - being medicines which:

(a)    only contain ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and

(b)   if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicines - none of the requirements have been contravened.

 

Thus, the required advisory statements for medicine labels set out in the legislative instrument made under subsection 3(5A) of the Act (RASML) will no longer apply to medicines that are or are required to be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods, and that are listed under section 26A of the Act.  Any such advisory statements, if applicable, will instead be included in the requirement applying to ingredients being contained in a medicine in a determination made by the Minister under paragraph 26BB(1)(b) of the Act (the section 26BB instrument).

 

Items 2 and 3 - Paragraph 10(b) and Part 1 of Schedule 3 (table item 1, paragraph (a))   

Items 2 and 3 omit the reference to "Part 1" in paragraph 10(b) of the Principal Regulations and also in table item 1, as Schedule 4 will no longer be divided into parts as a consequence of the amendments that would be made by Items 5 and 14. 

 

Item 4 - Part 1 of Schedule 3 (table item 2, paragraph (a))

Item 4 omits the reference to "items 3 to10 (inclusive) in Part 1" in item 1 of Part 1 of Schedule 3 to the Principal Regulations, and substitutes "item 3, 4A, 5 and 7". Items 4, 6, 8, 9 and 10 of Part 1 of Schedule 4 to the Principal Regulations are repealed as they will now be covered by item 3 of Schedule 4 to the Principal Regulations (refer to the amendments described in Items 7, 10 and 13 below). 

 

Item 5 - Part 1 of Schedule 4 (heading)

Item 5 repeals the heading "Part 1 of Schedule 4" as a consequential to amendments made by Item 14.

 

A medicine is considered "eligible for listing" if it is the type specified in regulations made under subsection 9A(4) or in a notice issued by the Minister under subsection 9A(5) of the Act, as therapeutic goods to be included in the part of the Register for listed goods. 

 

Regulation 10(b) of the Principal Regulations relevantly provides that for the purposes of paragraph 9A(4)(a) of the Act therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Part 1 of Schedule 4 that are included in the Register are to be included in the part of the Register for listed goods.

 

Currently, Part 1 of Schedule 4 to the Principal Regulations describes the classes of therapeutic goods that are "eligible for listing"; that is, those that are required to be included in the part of the Register for listed therapeutic goods.  In addition, Parts 2 -5 list the types of therapeutically active ingredients that preparations described in Part 1 of Schedule 4 may contain, as well as qualifications that apply to those ingredients. 

 

These amendments to the Principal Regulations omit the lists of therapeutically active ingredients and qualifications applying to these ingredients from Schedule 4.  The ingredients and qualification applying to those ingredients will instead be included in the section 26BB instrument. 

 

As a result, Schedule 4 will now only include a general list of therapeutic goods that are required to be included in the part of the Register for listed goods (whether listed under section 26 or under section 26A of the Act), subject to certain criteria being met.

 

Item 6 - Part 1 of Schedule 4 (table item 3)

Item 6 repeals the current table item 3 and substitutes it with a new item 3.  The current item 3 covers preparations containing as their therapeutically active ingredients vitamins, minerals, herbal substances, a substance mentioned in Part 2-5 of Schedule 4 to the Principal Regulations subject to the criteria described in paragraphs (a) to (g).  As these ingredients will now be covered in the section 26BB instrument, they are not included in the new item. 

 

New item 3 now covers any medicine that satisfies the following:

(a)    the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and

(b)   if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in a medicine, none of those requirements have been contravened; and

(c)    similar to existing item 3:

(i)           the ingredients in the medicine are not included in a Schedule to the Poisons Standard or Appendix C of that Standard, and are not of a kind required to be sterile; and

(ii)         the indications proposed by the sponsor of the medicine are not in relation to the treatment of a disease, condition or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code.

This item covers the majority of medicines that are "eligible for listing" on the Register under section 26A of the Act.

 

Item 7 - Part 1 of Schedule 4 (table item 4)

Item 7 repeals table item 4 of Part 1 of Schedule 4 as mother tinctures will now be included in the list of ingredients of a medicine in the proposed section 26BB instrument.

 

Item 8 - Part 1 of Schedule 4 (table item 4A)

Item 8 repeals table item 4A of Part 1 of Schedule 4 and substitutes a new item 4A which describes homeopathic preparations that consist of, or contain a dilution of mother tincture which is a 1,000 fold dilution or a lesser dilution of that mother tincture and the ingredients in the preparation meet the requirements of the proposed section 26BB instrument.

 

As with current item 4A, the ingredients of the preparation must not be specified in Appendix C of the Poisons Standard (other than any ingredient that is more than a 1,000-fold dilution of mother tincture), and the preparation must not be required to be sterile.

 

Item 9 -Part 1 of Schedule 4 (table item 5)

Item 9 repeals table item 5 of Part 1 of Schedule 4 and substitutes a new item 5, which refers to homeopathic preparation which consists of mother tinctures where each dilution is more dilute than a 1,000 fold dilution. These preparations are more dilute than those specified under new table item 4A; that is, these preparations contain only mother tinctures that are 1,000 fold dilution or greater.  The homeopathic preparation needs to meet the requirements of the proposed section 26BB instrument.

 

As with current item 5, the preparation must also not be required to be sterile and the indications proposed by the sponsor can be for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Code.

 

Item 10 - Part 1 of Schedule 4 (table item 6)

Item 10 repeals table item 6 of Part 1 of Schedule 4 that relates to medicated throat lozenges.  The specified ingredients and requirements applying to those ingredients would now be included in the section 26BB instrument. Medicated throat lozenges will now be covered by new table item 3 of Schedule 4.

 

Item 12 - Part 1 of Schedule 4 (table item 7, paragraph (c))

Item 12 repeals paragraph (c) of table item 7 of Part 1 of Schedule 4 as the Standard AS/NZS 2604:2012 no longer applies to sunscreen preparations which have a sun protection factor of less than 4.  In effect, item 7 will now only apply to sunscreen preparations which have a sun protection factor of 4 or greater. A new paragraph (c) is inserted so that the ingredients in the sunscreen preparation will need to meet the requirements of the section 26BB instrument.

 

Item 13 - Part 1 of Schedule 4 (table items 8, 9, 10 and 10A)

Item 13 repeals table items 8, 9, 10 and 10A of Part 1 of Schedule 4.  The ingredients specified in items 8-10A will now be included in the list of ingredients for listed medicines in the section 26BB instrument, including the requirements applying to those medicines.  The medicines described in items 8-10A will now be covered by new table item 3 of Schedule 4.

 

Item 14 - Parts 2, 3, 4 and 5 of Schedule 4

Item 14 repeals Parts 2, 3, 4 and 5 of Schedule 4 as the ingredients and qualifications applying to specified ingredients will now be included in the section 26BB instrument.  Schedule 4 will now only include a list of medicines, preparations or other therapeutic goods that can be listed under section 26 or under section 26A of the Act described in a general way, without specifying what ingredients they can or must contain. 

 

Item 15- Part 2 of Schedule 9 (after table item 7B)

Item 15 prescribes the evaluation fee in relation to an ingredient (table item 7C) or an excipient (table item 7D) which is the subject of an application for variation, made under subsection 26BD(1) of the Act, of a section 26BB instrument.  The evaluation fee under item 7D applies irrespective of the number of excipients covered by an application for variation of a determination under subsection 26BD(1).  In deciding whether to make such a variation, the Minister must have regard to the quality and safety of the ingredient/s or excipient.

 

The level of these fees reflects the current level of fees charged in the evaluation of ingredients or new excipients under regulation 16GA of the Principal Regulations. 

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Therapeutic Goods Amendment (Listed Medicines) Regulation 2015

 

This Therapeutic Goods Amendment (Listed Medicines) Regulation 2015 (the Regulation) 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.

 

Overview of the Bill/Legislative Instrument

 

The Regulation is made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act), and amends the Therapeutic Goods Regulations 1990 (the Principal Regulations). 

 

Schedule 4 of the Principal Regulations lists ingredients permitted for use in medicines listed under section 26A of the Act.  These are lower risk medicines which are not evaluated for quality, safety or efficacy before they are entered in the Australian Register of Therapeutic Goods (the Register).  Instead, the sponsors of such medicines must certify as to a range of matters when applying for listing in the Register, such as that their medicine is safe for its intended purpose.  Ingredients may also be permitted for use in listed medicines under notices made by the Minister under subsection 9A(5) of the Act.  Further, requirements relating to the use of ingredients permitted for use in listed medicines (e.g. in relation to the amount of an ingredient that can be included in a daily dose of such a medicine) can be found in a number of different instruments, including in notices made by the Minister under subsection 9A(5) of the Act, in the medicines advisory statement specification made by the Minister under subsection 9(5A) of the Act, and in Schedule 4 itself.

 

Under section 26BB of the Act, the Minister may make a determination listing ingredients that are permitted for use in listed medicines, and associated requirements relating to the use of those ingredients in these products.  When made, this determination will provide a single source of information relating to ingredients that may be used in listed medicines, and any related restrictions or requirements.

 

The purpose of the Regulation is, principally, to make consequential changes to Schedule 4 of the Principal Regulations to allow the determination to be made, and to avoid duplication and confusion. The Regulation also specifies evaluation fees that will apply in relation to the evaluation of requests to add new ingredients to the section 26BB determination.

 

Human rights implications

 

This legislative instrument does not engage any of the applicable rights or freedoms.

 

Conclusion

 

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

 

 

Fiona Nash, Minister for Rural Health