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According to the National Pharmaceutical Regulatory Agency (NPRA), antiseptic and skin disinfectant products that are intended for external use on the human body are categorized as registrable products under ‘pharmaceutical products containing non-scheduled poisons’.
TECOLAB assists customers with their Quest Membership Applications, Product Classification, Product Quality Document Preparation and Reliable Customer Product Registration Follow Ups.
Step 1: Quest membership Application
According to the National Pharmaceutical Regulatory Agency, Product Notification Holders (PNH) authorized by manufacturers shall first register for a Quest Membership through the NPRA Quest system.
TECOLAB readily guides and assist PNHs with their Quest Membership Application.
Note: A Quest USB token fee of RM 260.00 (1 year validity) or RM 290.00 (2 years validity) will be imposed.
Step 2: Product Classification
Pharmaceutical products that are intended to be registered shall be correctly classified according to:
- New Drug Products (NDP)
- Biologicals
- Pharmaceutical products containing scheduled poison
- Pharmaceutical products containing non-scheduled poison (OTC)
- Health supplements and natural products
TECOLAB readily assist customers to classify their products into the respective categories.
Note: Antiseptic and skin disinfectant products are classified as pharmaceutical products containing non-scheduled poison (OTC).
Step 3: Application submission and screening by NPRA
PNH will encounter two divisions mandatory to be filled during the online application:
Part 1: Product Validation:
- Product name
- Dosage form
- Active ingredients
- Product excipient
- Presence of animal origin
- Manufacturer details
- Additional product information
Part 2: New Registration Application Form
TECOLAB assist customers in submitting their product application.
Note: The requirements in Part 2 vary according to product category and type of evaluation. Click here to learn more.
Step 4: Abridged evaluation of antiseptics and skin disinfectant
Antiseptic and skin disinfectant products undergo an abridged evaluation instead of a full evaluation.
The duration of an abridged evaluation for a product with:
- A single active ingredient: 116 working days*
- Two or more active ingredients: 136 working days*
*The duration of evaluation period may differ and shall only be taken as an approximation.
Note: A processing fee and analysis fee will be imposed according to product category. Click here to learn more.
Step 5: Post-registration process and license application
After passing the evaluation, the PNH must apply for a manufacturer, import, and/or wholesale license in order to sell registered products in the Malaysian market.
TECOLAB readily assist customers to apply required license.
Note: A registration fee for each type of license will be imposed.