Household & Industrial Chemicals
Regulatory Affairs
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- 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) now known as the Australian Industrial Chemicals Introduction Scheme 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.
TGA Applications – Medicines, Ingredients, GMP Licenses, Disinfectants
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- Compilation and submission of applications for:
- Registrations for Therapeutic Goods onto the Australian Register of Therapeutic Goods (ARTG)
- Listings for Therapeutic Goods onto the ARTG via the Therapeutic Goods Administration’s (TGA’s) eBusiness Services (eBS) website
- New excipients to be added to the ARTG via the TGA’s eBS website
- Medicine/poisons scheduling to the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS)
- Product areas include OTC medicines, complementary medicines, nutritional supplements, traditional medicines, sunscreens and disinfectants.
- Confidential review and assistance with the following for Therapeutic Goods:
- Advice on claims for new or competitor products
- Ingredients
- Packaging and labels
- Potential safety or health risks
- Importing, exporting, manufacturing and marketing
- 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
- Technical assessment and assistance with respect to:
- Good Manufacturing Practice
- Self GMP audits
- Stability studies
- Finished product specifications
- Sponsor/ Manufacturer GMP contracts
- Quality Assurance documents
Foods
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- 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)
- Food, GMP, GHS, PIC/S Auditing, Labelling, ADG, GHS, SUSMP advice
The EHP team consists of four regulatory affairs directors as well as three regulatory affairs officers providing additional support and assistance to support our extensive client base. We have decades of regulatory and compliance experience between us and we can help you with all aspects of regulation and compliance involving Cosmetics, Household and Personal Care, Sunscreens, Disinfectants and Cleaning Products, Complementary Medicines, List & Registered Medicines, Medical Devices, Food & Food Supplements, PIC/S GMP Audit & Training.
When it come to industrial and household chemicals we can assist with all label requirements including SUSMP/Poisons Standard, GHS, ADG, Aerosols as well as drafting SDS for compliance with GHS requirements for both Australia and New Zealand.
All four Directors are on numerous industry committees working groups, and Standards bodies – this ensures that we are providing an industry perspective when it comes to consultations and standards setting process. It also means that we are across the constant regulatory reforms that are constantly taking place! Our fingers are always on the pulse! Please feel free to contact us for more information.