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Australian regulatory guidelines for sunscreens (ARGS)
6. Changes to sunscreens
This guideline is currently under review.
Details of the requirements and procedures for making changes to the ARTG record of listed therapeutic goods are provided in the ELF User Guide.
6.1 Changes to active ingredients
The addition to or deletion of an active ingredient to a product or a change to the quantity of such an ingredient creates a new therapeutic good requiring an application to be made for a new entry in the ARTG (see subsections 16(1) and 16(1A) of the Act and regulation 11 of the Regulations). If successful, a new AUST L or AUST R number will be assigned to the new product.
6.2 Changes to excipients
The identities of excipients in a sunscreen product and the quantities of 'restricted ingredients' are required to be included in the ARTG record for the product.
Deletion or addition of excipients in a therapeutic sunscreen (other than the permanent removal or addition of a fragrance or colouring agent) creates a new therapeutic good requiring an application to be made for listing or registration in the ARTG as a new product. If successful, a new AUST L or AUST R number will be assigned to the new product.
If the excipient to be added or removed is a fragrance or colouring then, notwithstanding that a new therapeutic good is created, the new product can retain the same AUST L or AUST R number under the Therapeutic Goods (Groups) Order No. 1 of 2001 (the Grouping Order) provided the new formulation is intended to replace the existing formulation. However, an electronic application must be submitted to change the formulation recorded in the ARTG
Quantities of excipients other than restricted excipients are not required to be included in the ARTG record for listed sunscreens.
Where a change is to be made to the quantity of a restricted excipient and grouping applies in accordance with the Grouping Order subsection 5.1(a)(i) and (ii) and (b) an electronic application must be lodged to change the formulation details recorded in the ARTG. When grouping does not apply, such a change will require a new product application and a new AUST L or AUST R number.
Sponsors should recognise that the SPF and other physical properties of a sunscreen are affected not only by the active ingredients, but also by the base. Therefore, qualitative or quantitative changes in the excipients may adversely affect the SPF. Testing of a changed formulation to confirm its SPF or stability may be required if the changes are likely to affect the emulsion properties or the adhesion of the product to the skin in a way that could alter its sun protection properties.
6.3 Other changes
Changes to the ARTG details of a sunscreen product must be approved by or notified to the TGA (using the ELF system in the case of a listed sunscreen). Whether or not grouping applies, a change to the product name requires approval.