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According to the National Pharmaceutical Regulatory Agency (NPRA), cosmetic products are substances that are intended to be placed in contact with various external areas of the human body (includes teeth and the mucous membranes of the human oral cavity). They are mainly used to clean, perfume, change the appearance, correct body odours, protect, or keeping these body parts in good condition.
TECOLAB assists customers with their Quest Membership Applications, Product Information File Preparation and Reliable Customer Product Registration Follow Ups.
Step 1: Quest membership Application
According to the National Pharmaceutical Regulatory Agency, Cosmetic Notification Holders (CNH) authorized by manufacturers shall first register for a Quest Membership through the NPRA Quest system.
TECOLAB readily guides and assist CNHs with their Quest Membership Application.
Note: A processing fee for cosmetic product notification of RM 50.00 will be imposed for each product.
Step 2: Product Information File (PIF) Preparation and Support
CNHs shall ensure the compliance to these elements of the cosmetic product intended for registration are readily available in a Product Information File (PIF) before notification submission:
- Administrative documents and product summary
- Quality data of raw materials
- Quality data of finished product
- Safety and efficacy data of product
TECOLAB readily assist customers in Product Information File Preparation.
Once your product has passed the compliance screening, a Notification Note will be generated by NPRA to allow the manufacturing, import, and/or marketing of your cosmetic product.
Step 3: Post-market surveillance by NPRA
Your cosmetic product will undergo a post-market surveillance (PMS) by the NPRA which will include:
- Screening of product formulation and information
- Product sample collection and testing by NPRA
- Product label compliance
- Cosmetic Good Manufacturing Practice (cGMP) Compliance
- Product complaints
- Monitoring product advertisements
- Monitoring product adverse reactions
- Product Information File (PIF) audit
- Risk communication
- Activities through ASEAN Post Marketing Alert System (PMAS)