Cosmetic Product Notification Services

Streamlined submission and compliance management for cosmetic products via the NPRA Quest3+ system. Fast, compliant market entry.

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Service Overview

In Malaysia, cosmetic products are regulated by the National Pharmaceutical Regulatory Agency (NPRA) under the Control of Drugs and Cosmetics Regulations 1984. Unlike drugs, cosmetics undergo a notification process rather than pre-market approval. However, post-market surveillance is rigorous.

ARCI assists manufacturers and importers in compiling the Product Information File (PIF), reviewing formulation safety, and submitting notifications through the Quest3+ system to ensure full compliance with the ASEAN Cosmetic Directive.

Who This Is For

  • International cosmetic brands entering Malaysia.
  • Local manufacturers of skincare and personal care products.
  • Distributors seeking to become the notification holder.

Regulatory Pathway & Process

1. Ingredient Review

Screening formulations against the NPRA Banned & Restricted List to ensure safety and compliance.

2. PIF Compilation

Preparation of the Product Information File (PIF) as required for post-market audits by the MOH.

3. Quest3+ Submission

Formal submission of the notification to the NPRA and management of any subsequent queries.

4. Post-Market Surveillance (PMS) Support

Advisory and operational support to Cosmetic Notification Holders (CNHs) in meeting post-market surveillance obligations, including:

  • Complaint Handling System Setup
  • Adverse Event Reporting Readiness
  • Regulatory Risk & Recall Preparedness

Cosmetic Notification FAQs

What is the validity period of a cosmetic notification? ▼
A cosmetic notification is valid for 2 years. Renewal must be done no later than 1 month before the expiry date via the Quest3+ system.
Is label review required before notification? ▼
While pre-market approval of labels is not required, your labels must strictly comply with the labelling requirements of the Guidelines for Control of Cosmetic Products in Malaysia. Our consultants ensure your post-market activities fully comply with regulations, safeguarding your cosmetic notification from suspension or cancellation.
Can I claim therapeutic benefits for my cosmetic product? ▼
No. Cosmetic products cannot make medicinal or therapeutic claims. If such claims are made, the product may be reclassified as a drug, requiring full registration.