Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1--Variation of entries in Register                                                                                   2

Part 1--Registered complementary medicines and registered OTC medicines         2

Therapeutic Goods Regulations 1990                                                                                               2

Part 2--Prescription medicines                                                                                                           5

Therapeutic Goods Regulations 1990                                                                                               5

Schedule 2--Exemptions                                                                                                                            13

Therapeutic Goods (Medical Devices) Regulations 2002                                                           13

Therapeutic Goods Regulations 1990                                                                                             14

Schedule 3--Permissible ingredients                                                                                                  16

Therapeutic Goods Regulations 1990                                                                                             16

Schedule 4--Approval of medicines                                                                                                   17

Therapeutic Goods Regulations 1990                                                                                             17

Schedule 5--Record-keeping etc.                                                                                                         22

Therapeutic Goods Regulations 1990                                                                                             22

Schedule 6--Public notification and recalls                                                                                   23

Therapeutic Goods (Medical Devices) Regulations 2002                                                           23

Therapeutic Goods Regulations 1990                                                                                             23

Schedule 7--Orphan drugs                                                                                                                      24

Therapeutic Goods Regulations 1990                                                                                             24

Schedule 8--Miscellaneous amendments                                                                                         29

Therapeutic Goods (Medical Devices) Regulations 2002                                                           29

Therapeutic Goods Regulations 1990                                                                                             31

Schedule 9--Transitional provisions                                                                                                  32

Therapeutic Goods Regulations 1990                                                                                             32

 

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