This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.

This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.
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Consultation: Business Process Improvements Supporting Complementary Medicines Assessment Pathways

The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines, to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation.

The consultation discusses:

A risk-based approach to […]

Updated Permissible Ingredients Determination

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017.

A total of 287 […]

October 13th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Pharmacovigilance Update

On 1st September 2017, the TGA published the revised edition (Version 2.0) of the ‘Pharmacovigilance responsibilities of medicine sponsors – Australian recommendations and requirements’.  This guidance sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register […]

September 26th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Listed Medicine Reforms – Permitted Indications and Application Fees

Permitted Indications

The closing date for proposing additional indications or evidence qualifiers to the TGA to be considered for the core list of permitted indications, is 31 October 2017. After this date, the list will be finalised and if sponsors […]

September 26th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Third Assessment Pathway for Listed Complementary Medicines

Intermediate Level – Listed Assessed Medicines

Reform recommendations for complementary medicines has seen the development of a three-tiered, risk-based framework for the regulation of CAM’s. The revised framework introduces a new (intermediate risk) assessment pathway sitting between the existing listed medicine […]

September 26th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Low THC Hemp Seeds Permitted as Foods

12 November 2017 will see the variation to Standard 1.4.4 – Prohibited and restricted plants and fungi to permit the sale of foods derived from the seeds of low THC varieties of C. sativa come into effect.

Maximum levels of THC […]

September 26th, 2017|Foods, FSANZ, Regulation|

Labelling Revised – Amendments to the Therapeutic Goods Order No. 92

The four-year transition period for the new labelling requirements (from TGO 69 to TGO 92), ends on 31 August 2020. During this time, you can choose to comply with the old labelling requirements under TGO 69 or the new labelling […]

Pharmacovigilance Inspection Program

As of 1 September 2017 the TGA’s Pharmacovigilance Inspection Program (PVIP) will be commencing.

Pharmacovigilance refers to the monitoring and prevention of the adverse effects of medicines, after they have been approved for use. All sponsors are legally responsible for meeting […]

Listed Medicine Reforms – Draft List of Permitted Indications

In September 2016, the Government announced that the TGA would introduce a list of permitted indications that must be used by listed medicine sponsors to enter their product indications in the ARTG. There will be no option when listing a […]

Updates to the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) on 15 July 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017.

This update to […]

July 27th, 2017|Complementary Medicines, Listed Medicines, TGA|