-OEM Product Application Process & Compliance Tips
Key words:MOOYAM OEM; Australia ARTG Cosmetic Registration; OEM Product Application Process & Compliance Tips;
ARTG (Australian Register of Therapeutic Goods) registration, supervised by Australia’s TGA, is mandatory for skincare OEM products entering the Australian market. For OEMs, mastering its application process and compliance points is key to legal market access and product safety. This article outlines the core ARTG registration process and compliance tips for OEM products, guiding brands to enter the Australian market compliantly.
ARTG Cosmetic Registration Application Process for OEM Products
1. Pre-Application Preparation
Pre-application preparation includes product classification and document collation. TGA classifies skincare into general and therapeutic cosmetics (the latter for products with medical claims, requiring stricter registration). Key documents include product formula, safety assessment report, labeling samples, GMP certification, and laboratory test reports; imported OEM products also need free sale and origin certificates.
2. Application Submission and Review Process
ARTG applications are submitted online via the TGA portal in three stages: account registration and enterprise filing, material upload/submission with fees, and TGA review. General cosmetics take 4-6 weeks to review, therapeutic ones 3-6 months. Approved products get an ARTG number, which must be marked on packaging.
Compliance Tips for OEM ARTG Cosmetic Registration
Key compliance tips: 1. Ingredient compliance: All ingredients must be in AICS, with prohibited/restricted ingredients and heavy metals (mercury ≤1mg/kg, lead ≤10mg/kg) meeting TGA limits. 2. Labeling compliance: English labels must include ARTG number, ingredient list, manufacturer info, Australian sponsor details, and no false claims. 3. Post-registration compliance: Update product info timely and cooperate with TGA inspections. MOOYAM OEM offers one-stop services adhering to TGA, ISO 22716 and GMP standards to help brands complete ARTG registration efficiently.
