Articles

The TGA Prescription Medicines Streamlined Submissions Process Newsletter [formerly the Prescription medicine BPR update (BPR update)] reports on progress of the streamlined submission process.

The Therapeutic Goods Administration (TGA) has received reports of haemodialysis catheters becoming dislodged at the Luer lock connection point. In some cases, the dislodgment was not detected, as the catheter and all connections were out of sight.

The Prescription medicine BPR update (BPR update) reports on progress of the streamlined submission process. Each quarter, an update is provided on the PI/CMI project and the AusPAR project.

The TGA's Incident Reporting and Investigation Scheme receives reports about the safety and performance of medical devices as part of its ongoing monitoring of products supplied in Australia. As part of this process the TGA has recently reviewed several reports associated with repaired endoscopes. These reports relate to the quality of the repair and the use of unsuitable parts.

Therapeutic Goods Order No. 1 of 2010.

This Order may be cited as the Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2004.

Listing notice - fungal enzymes

Listing notice - curcumin

Listing notice - iron phosphate

Listing notice - Terminalia ferdinandiana (Kakadu plum)

Listing notice - sodium sulfate

Listing notice - cold-pressed neem (Azadirachta indica) seed oil

Listing notice - Trametes versicolor hyphae aqueous extract - powder

Listing notice - boric acid, borax, sodium perborate, borax pentahydrate, molybdenum trioxide, magnesium phosphate dibasic trihydrate

Listing notice - emu oil

Listing notice - zeaxanthin

Listing notice - lutein

Listing notice - activated charcoal

Listing notice - bovine colostrum powder

Listing notice - bovine colostrum powder

Listing notice - demineralised fish proteoglycan extract

Listing notice - black boned chicken powder, conifer phytosterol complex

Listing notice - (S)-S-Adenosylmethionine & ademetionine in the form of sulfate, tosylate or mixed sulfate/tosylate salts

Listing notice - Streptococcus thermophilus, Morinda citrifolia fruit juice, Pseudowintera colorata leaf

Listing notice - lycopene, thiamine phosphoric acid ester chloride, sugar cane wax alcohols