Written & researched by Aiman Zafran, Industry Writer · Reviewed by Marites Rabelo · Published by OEM2YOU · Last reviewed July 2026
Disclosure: This article is published by OEM2YOU, a cosmetics OEM/ODM manufacturer. It refers to our own manufacturing services and experience. External factual claims are supported by the cited sources.
Quick answer
Before any cosmetic can be sold in Malaysia it must be notified to the NPRA (National Pharmaceutical Regulatory Agency). Notification is an online declaration of the product, its ingredients and its responsible company — not a lengthy approval process — but the formula must comply with the ASEAN Cosmetic Directive’s ingredient rules, and the person or company notifying takes legal responsibility for the product. In an OEM project, the manufacturer normally prepares or supports the notification, so a first-time brand owner rarely files alone.
Key takeaways
- Notification is mandatory before sale — selling an un-notified cosmetic is an offence under the Control of Drugs and Cosmetics Regulations 1984.
- It is a declaration, not a product approval: responsibility for safety and claims stays with the notification holder.
- The formula must comply with ASEAN Cosmetic Directive ingredient annexes (banned and restricted substances).
- Keep the Product Information File (PIF) ready — NPRA can request it at any time.
Who must notify the product?
The notification is made by a company registered in Malaysia — usually either the brand owner’s company or the manufacturer on the brand’s behalf. Whoever holds the notification is the responsible party for the product in the Malaysian market. Discuss with your manufacturer which arrangement fits your brand; both are common in OEM projects.
What does the notification process involve?
- Confirm the product category — the product must genuinely be a cosmetic (applied externally for cleansing, beautifying or protecting). Products with therapeutic claims fall under different, stricter regimes.
- Screen the formula — every ingredient checked against the ASEAN Cosmetic Directive’s annexes of banned and restricted substances and permitted colourants, preservatives and UV filters.
- Prepare product details — product name, full ingredient list (INCI names), manufacturer details, responsible company.
- Submit online — through NPRA’s notification system, with the official fee per product.
- Receive the notification number — once acknowledged, the product may be marketed. Keep the number; retailers and marketplaces increasingly ask for it.
- Maintain the PIF — the Product Information File holds the formula, specifications, stability data, safety assessment and label artwork, ready for any NPRA request.
Current forms, fees and guidelines are published on the official NPRA website.
What can go wrong — and how to avoid it
- Non-compliant ingredients — usually from copying an overseas formula; ASEAN annexes differ from the EU or US. Screening before development avoids re-formulation later.
- Over-claiming — “treats eczema” or “removes scars” are therapeutic claims that a cosmetic cannot make. NPRA publishes claims guidance; match your marketing to it.
- Notification after launch — marketplaces can delist you and the regulator can act. Notify first, sell second.
- No PIF — the file is often forgotten until it is requested. A GMP manufacturer builds it as part of the project.
How OEM2YOU handles notification in a project
Regulatory screening happens at the formulation stage, not after: because each formula is developed for one brand only, the ingredient list is designed around your target markets from the start — Malaysia first, and any export markets you name in the brief. Notification support and the supporting documentation come with the project; see the full development flow in the complete OEM cosmetics guide or our R&D, testing & registration page.
Frequently asked questions
How long does NPRA notification take?
The online notification itself is fast once the dossier is complete; the real time sits in formula screening and document preparation. Plan it inside the development timeline, not after production.
Does notification expire?
Notifications have a validity period and must be renewed to keep the product on the market — check the current validity terms on the NPRA website.
Is one notification enough for all my products?
No — each product (and in some cases each variant) requires its own notification.
Can I sell on Shopee or TikTok Shop without a notification number?
Legally the product must be notified before sale anywhere in Malaysia, and major marketplaces increasingly verify notification numbers for cosmetics listings.
Sources & references
- National Pharmaceutical Regulatory Agency (NPRA) — cosmetic notification guidelines and fees.
- Control of Drugs and Cosmetics Regulations 1984, Malaysia.
- ASEAN Cosmetic Directive — ingredient annexes and labelling requirements.
Update history
July 2026 — First published.
Developing a product for the Malaysian market? Start with a brief in the quotation form — regulatory screening is built into our development process.