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We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

TCMs sold in Australia are carefully regulated to ensure safety and quality.

If your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.

We know that paracetamol is safe and effective for most people when taken at the recommended dose.

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices.

The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.

‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).

From 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG).

To help sponsors and manufacturers transition to new manufacturer evidence.

Want to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.

Transition period for accepting ISO 13485 ends 26 May 2023.

Delays in processing timeframes of applications to extend GMP Clearances.

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

The TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.