The Permissible Indications Determination requires certain label statements, depending on the potential risk associated with the use of a specific indication. Label statements are being brought into line with the language being used in the new advertising code moving from […]
Permitted indications for Pregnancy Supplements
Recent communication from the TGA has confirmed the guidelines around the use of permitted indications in Pregnancy and foetal development. These guidelines differ significantly to what has been acceptable in the past. Due to the vulnerability […]
Are population qualifiers mandatory?
An indication must be qualified on medicine labels (or other advertising), either explicitly or by implication, if it is qualified in the ARTG entry. There is no need to add a qualifier on a medicine label (or […]
Are you clear on what FSANZ’s role is in food regulation?
If not take 2 minutes to view this simple explanation
TGO 92 impacts on product name presentation
The new labelling legislation states that, as per TGO 92, ‘The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by additional […]
The TGA will no longer be assessing Herbal Component Names (HCN’s) as part of pre-market evaluations, effective immediately. Effective 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in […]
TGA Clearance applications for overseas manufacturers are now required to be submitted along with a GMP Agreement detailing arrangements between the sponsor and manufacturer. The TGA has indicated that in addition to the normal scope of GMP Agreements, specific areas […]
Effective March 8th 2018 Permitted indications are now available through eBS for listed medicines.
The TGA has implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act).
The list of permitted indications […]
The Therapeutic Goods Amendment Bill No.1. of 2017 received royal ascent on Monday 5th March, as such the proposed reforms have now begun to be implemented.
As of midday yesterday (6th March 2018), the TGA have temporarily closed the application section […]
The Uniform Recall Procedure for Therapeutic Goods (URPTG) is a guidance document, which provides a standardised systematic procedure, to assist sponsors to conduct both recall and non-recall actions of therapeutic goods which are supplied, imported into or exported from Australia.