Medicines, Poisons and Therapeutic Goods Amendment Regulation 2014 (No 1) (ACT)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2014 (No 1)

Subordinate Law SL2014-23

The Australian Capital Territory Executive makes the following regulation under the Medicines, Poisons and Therapeutic Goods Act 2008.

Dated 18 September 2014.

Katy Gallagher

Minister

Andrew Barr

Minister

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2014 (No 1)

Subordinate Law SL2014-23

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

Contents

Page

1            Name of regulation  1

2            Commencement  1

3            Legislation amended  1

4            Section 270 (a) (i)  1

5            Section 270 (a), note  1

6            Section 461 (b) (i)  1

7           Section 461 (b), note  2

8            Section 650, note  2

9            New section 863 (aa) and (ab)  2

10          Section 863, new notes  2

11          Schedule 3, part 3.2, new item 6  2

12          Dictionary, new definition of Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8  3

13          Dictionary, definition of Australian code of good wholesaling practice for therapeutic goods for human use  3

14          Dictionary, definition of medicines Australia code of conduct, note          3

15          Dictionary, definition of Optometry Endorsement Scheduled Medicines Registration Standard   4

1. Name of regulation

   This regulation is the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2014 (No 1).

2. Commencement

   (1)This regulation (other than section 11) commences on the day after this regulation’s  notification day.

   NoteThe naming and commencement provisions automatically commence on the notification day (see Legislation Act, s 75 (1)).

   (2)Section 11 commences on 1 October 2014.

3. Legislation amended

   This regulation amends the Medicines, Poisons and Therapeutic Goods Regulation 2008.

4. Section 270 (a) (i)

   substitute

   (i)the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8; and

5. Section 270 (a), note

   substitute

   NoteAustralian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 and medicines Australia code of conduct—see the dictionary.

6. Section 461 (b) (i)

   substitute

   (i)the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8; and

7. Section 461 (b), note

   substitute

   NoteAustralian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 and medicines Australia code of conduct—see the dictionary.

8. Section 650, note

   substitute

   NoteThe Price Information Code of Practice is accessible at >

   New section 863 (aa) and (ab)

   insert

   (aa)the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8;

   (ab)the medicines Australia code of conduct;

9. Section 863, new notes

   insert

   Note 3AThe Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 is accessible at 3BThe Medicines Australia Code of Conduct is accessible at >

   Schedule 3, part 3.2, new item 6

   before the note, insert

6 specialist practising in specialist area of neurology, paediatrics or sleep medicine sodium oxybate for human use

1. Dictionary, new definition of Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8

   insert

   Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 means the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 prepared by the National Coordinating Committee on Therapeutic Goods, as in force from time to time.

   NoteThe Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 is accessible at >

   Dictionary, definition of Australian code of good wholesaling practice for therapeutic goods for human use

   omit

2. Dictionary, definition of medicines Australia code of conduct, note

   substitute

   NoteThe Medicines Australia Code of Conduct is accessible at >

   Dictionary, definition of Optometry Endorsement Scheduled Medicines Registration Standard

   substitute

   Optometry endorsement scheduled medicines registration standard means the Optometry Endorsement Scheduled Medicines Registration Standard approved by the Ministerial Council under the Health Practitioner Regulation National Law (ACT), section 12, as in force from time to time.

   NoteThe Optometry Endorsement Scheduled Medicines Registration Standard is accessible at type="1">

   Notification

   Notified under the Legislation Act on 25 September 2014.

   Republications of amended laws

   For the latest republication of amended laws, see align="center">© Australian Capital Territory 2014