Understanding TGA GMP Clearance
Understanding TGA Good Manufacturing Practice (GMP) requirements for Australian Regulatory Submissions Good Manufacturing Practice (GMP) is vital in ensuring the quality, safety, and efficacy of the therapeutic goods for human use (including sunscreens). In Australia, the Therapeutic Goods Administration (TGA) oversees the implementation and enforcement of GMP standards to uphold the integrity of the pharmaceutical…
EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?
The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the most significant change to the landscape in decades. Despite the postponement of the EU Medical Devices Regulation’s implementation to May 2021 appearing to offer
Consumer Insecurity / Vanity Targeted by TGA – Massive Fines
The appearance of misleading terms and claims on websites and social media has attracted the attention of the TGA. The Therapeutic Goods Administration in Australia (TGA) has advised that fines were imposed via the Federal Court for misleading advertising by Peptide Clinics Australia (Peptide Clinics Pty Ltd), to the tune of $10 million (for breaches…
Australian Employment Regulations
Today, we are pleased to introduce one of our affiliates and guest blogger, Anna Pannuzzo from WorkPlacePLUS. In this post, Anna discusses some key workplace health, safety and other legal aspects of setting up or maintaining a sales office in Australia. Expanding your business can be an exciting time, but setting up abroad comes with…
Advertising Therapeutic Goods in Australia
If you’re advertizing therapeutic goods in Australia in 2019, there’s new legislation that is critical to your successful campaign/s. We’ve been keeping up to date over the break to ensure we’re ready to assist our clients with all of their commercialization needs around the globe.
