Permissible ingredients
THE Therapeutic Goods Administration (TGA) has made a total of 88 changes in the updated Permissible Ingredients Determination labelled No. 2 of 2018.
The listing provides transitional arrangements for medicines that are currently listed in the Register to comply with new requirements included in the previous determination.
These include requirements such as new concentration limits or safety information required on product labels.
The listing contains nine new ingredients and makes changes to 75 existing ingredient entries.
These latter are designed to make requirements either less restrictive such as broadening the administration options, or more restrictive such as requiring warning statements and transitional provisions.
Some changes reflect existing requirements from the Poisons Standard while some make minor changes to ensure greater clarity with entries.
Four ingredients were identified as not to be suitable for inclusion in listed medicines or were synonymous with other existing ingredients to avoid duplication. These were lovage extract, meadowsweet herb powder, mentha x piperita nothosubsp. citrata and raisin.
Visit tga.gov.au for the complete listing of changed ingredients. MEANWHILE the TGA has announced a revised fees and charges model for domestic manufacturers to take effect 01 Jul.
The revision is based on the proposal to change the current Good Manufacturing Process fees and charges public consultation carried out earlier this year.
See tga.gov.au for details.