April 21, 2019

Services Australia and New Zealand

Regulatory Affairs

Current regulatory awareness
Early warning of changes in relevant areas of regulation by regulatory authorities on industry
Confidential assessment of potential safety or health risks for products
Confidential review of advertising claims and their substantiation
Assistance with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Australian Inventory of Chemical Substances (AICS)
Co-ordination between industry and agencies with respect to technical, scientific or toxicological evidence
Technical assessments for acquisitions
Provision of information to marketing personnel as required
The review of products for compliance to the National Trade Measurement Act and Regulations.

Cosmetics

Confidential review of ingredients in cosmetic products to ensure they are on the AICS and are not restricted by entries in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
Confidential review of packaging to check country of origin, trade measurement and ingredient labelling compliance
Advice on cosmetic versus therapeutic claims
Advice on claims for new or competitor products
Advice on manufacturing, marketing, import or export of cosmetic products
Assistance with registration with NICNAS as a cosmetic or industrial chemical importer
Interaction with NICNAS to notify or exempt new ingredients not on AICS including writing notifications and permit applications
Advice on the safety or health risks of cosmetic or industrial chemical ingredients and products
Advice on the writing of Safety Data Sheets (SDSs) to the Australian approved format
Advice on compliance with NICNAS Cosmetic Guidelines and Cosmetic Standard
Compliance with Environmental Protection Authority (EPA) New Zealand Group Standards including the Cosmetic Group Standard.

Medicines, Sunscreens and Disinfectants

Compilation and review of published medical and scientific data for inclusion as supporting evidence in submissions and presentations to government authorities e.g. Therapeutic Goods Administration (TGA) Australia and the New Zealand Medicines and Medical Safety Authority (Medsafe):
- Submissions to TGA of APIs and Complementary Medicines Actives
- Submissions to TGA of data and excipients
- Personal representation to government health departments (state and federal)
- Related Product Notifications to Medsafe (NZ)
- Medsafe (NZ) registrations
Safety assessment and assistance with respect to:
- Pharmaceutical, herbal and sunscreen actives
- Finished products

Medical Devices

Compilation of inclusions for Therapeutic Devices onto the ARTG via the TGA’s eBS website
Confidential review and assistance with the following for Therapeutic Devices:
- Advice on claims for new or competitor products
- Ingredients
- Packaging and labels
- Device application audits
- Importing, exporting, manufacturing and advertising review
- Notification of Therapeutic Devices to Medsafe (NZ) via Web Assisted Notification of Devices (WAND).

Foods

Review of formulations for conformity to the Food Standards Australia New Zealand (FSANZ) Food Standards Code
Advice on food laws and fair trading laws
Advice on Food Safety Standards and hygiene regulations
Confidential review and assistance with the following for foods:
- Advice on claims for new or competitor products
- Ingredients
- Packaging and labels
- Potential safety or health risks
- Generating supportive data for claims
- Importing, exporting, manufacturing and marketing
Personal representation to government authorities
Technical assessment and assistance with respect to Good Manufacturing Practice (and internal auditing).