NPRA Cosmetic Notification in Malaysia: Steps, Fees, Timeline and Who Holds It

Every cosmetic sold in Malaysia must be notified to NPRA first. What notification is and is not, what it costs, how long it takes, and who should hold it when a factory makes your product.

Key takeaways

• Notification is mandatory; “approval” is the wrong word. No one may manufacture, sell, supply, import or possess an un-notified cosmetic.
• Government fees are small: RM50 per product and per variant, RM50 per renewal every two years, plus a Quest3+ membership from RM260.
• NPRA’s clock is short (1–3 working days after payment); documents and screening queries are what add weeks.
• The holder carries the legal duties, so decide early whether your company or the manufacturer holds the notification.
• Keep off the pack: the notification number, “Approved by MOH” and GMP or ISO 22716 logos.

What this guide covers

This guide is for brand owners launching skincare, makeup, hair, body-care and fragrance products in Malaysia, made locally or imported. It follows NPRA’s Guidelines for Control of Cosmetic Products in Malaysia (Second Edition, 2022) and NPRA’s FAQ, checked in October 2026. Products near the drug or device line follow other routes; see how Malaysia separates cosmetics, drugs and medical devices.

A cosmetic notification is a declaration to the Director of Pharmaceutical Services, made through NPRA, that a product complies with Malaysia’s cosmetic rules. The Cosmetic Notification Holder (CNH) is the Malaysian company responsible for placing the product on the market. A Product Information File (PIF) is the technical and safety dossier behind each notified product.

Do cosmetics need NPRA approval in Malaysia?

Cosmetics in Malaysia need NPRA notification, not approval. Since 1 January 2008, in line with the ASEAN Cosmetic Directive, Regulation 18A of the Control of Drugs and Cosmetics Regulations 1984 has required every cosmetic to be notified, and NPRA’s FAQ confirms that prior approval no longer applies. The holder declares compliance; the regulator checks.

It is not a formality. NPRA screens every submission and rejects products with prohibited substances, restricted ingredients above their limits, or claims beyond the cosmetic scope. After launch, a notification can be cancelled at any time for non-compliance, with recall and disposal. A new local manufacturer or production line must also pass an NPRA inspection before its products are notified.

Who can hold a cosmetic notification: the brand or the factory?

The CNH must be a locally incorporated company in the field of cosmetics, with a permanent address and an SSM-registered business scope covering health or cosmetic products. It may or may not be the product owner. Brands usually choose one of three set-ups:

One rule shapes the choice: NPRA’s FAQ says an added, substituted or changed manufacturer requires a new notification. A brand that may add a second factory is better served by holding its own notifications from the start.

How does NPRA cosmetic notification work, step by step?

1. Confirm it is a cosmetic using the five-step test in NPRA’s claims guideline (composition, site of application, main function, presentation, physiological effect).
2. Check ingredients against the Annexes: Annex II is prohibited, Annex III restricted, and colourants, preservatives and UV filters must come from Annexes IV, VI and VII.
3. Register for Quest3+ with a digital certificate on a USB token.
4. Prepare the particulars: product details and intended use, manufacturer, holder and importer details, the full ingredient list with restricted-ingredient percentages, authorisation letters and the label.
5. Submit one form per product and per variant, and pay RM50 each.
6. Answer screening queries in the system’s correspondence section; screening resumes only after you reply.
7. Print the Notification Note, which authorises manufacture, import and sale.
8. Keep it current: update the PIF, file changes and renew at least one month before the two-year expiry.

How much does NPRA cosmetic notification cost, and how long does it take?

NPRA’s fees are modest; most launch costs sit with laboratories, safety assessors and packaging. Official figures, checked in October 2026:

A product variant is an item in a range from the same manufacturer, similar in composition and for the same use, that differs only in colour, fragrance or flavour. Twelve lipstick shades are twelve RM50 variant fees; ranges with different bases are separate products. For export paperwork, see our guide to cosmetic export documents.

The 1–3 working days assume a complete, compliant file. The real calendar is set earlier: restricted-ingredient confirmations, the signed safety assessment, stability data for the shelf life, and artwork that passes the claims rules. Settle those before printing packaging.

What goes into the Product Information File (PIF)?

NPRA recommends a four-part PIF, in Bahasa Malaysia or English, kept at the address on the label and retained for at least three years after the product was last placed on the market.

The holder answers for the whole file even when most pages come from the factory, so agree in the manufacturing contract which documents the factory supplies and when. Stability and safety-related testing options are on our product testing page.

What does the holder have to do after launch?

• Keep every batch compliant and the PIF updated for each change of ingredient, supplier, manufacturer or process.
• Keep distribution records and recall stock when NPRA directs.
• Ensure the manufacturer complies with cosmetic Good Manufacturing Practice (GMP).
• Report serious adverse events and investigate complaints.

NPRA checks these duties through market sampling and testing, label and advertisement monitoring, GMP audits and PIF audits. A requested sample must be four unopened units from one batch, at least 40 g or 40 ml in total, with a year of shelf life left.

What should and should not appear on the label?

A cosmetic label must show, in Bahasa Malaysia and/or English: name and function, directions where needed, the full ingredient list in descending order, country of manufacture, the CNH’s name and address, net contents, batch number, and a manufacturing or expiry date (expiry is mandatory if the product lasts under 30 months), plus precautions and any animal-origin ingredients.

NPRA’s FAQ says the notification number is not to be printed on the label, and its claims guideline lists “Approved by Ministry of Health (MOH)” and GMP logos, including ISO 22716, as unacceptable. A Halal logo needs product certification by JAKIM or a JAKIM-recognised body. See what a cosmetic label can and cannot claim and our comparison of NPRA GMP and ISO 22716.

ORIZI perspective: what the register shows about who holds notifications

Dr Orizi (M) Sdn. Bhd., ORIZI Group’s cosmetics manufacturer, has held NPRA cosmetic GMP since 2024 and ISO 22716 since 2022, and hosted NPRA’s routine GMP surveillance audit in July 2026. Because every notification names its manufacturer, anyone can check in NPRA’s public product search which factory makes a notified product.

Our reading is practical. The holder controls renewals, new variants and any change of factory, so growing brands usually want that control in-house. The manufacturer’s job is to make holding easy by supplying INCI formulas, specifications, stability summaries, certificates of analysis and the GMP statement in a fileable form, and our regulatory affairs team supports submission for brands that want help. Limits: these figures cover one manufacturer’s active entries on one date; lapsed notifications drop off the register.

Common mistakes that delay or undo a notification

• Printing packaging before screening: claims such as “heals acne” or “stimulates hair growth” lead to rejection.
• Calling a notified product “KKM approved” on the pack or in adverts.
• Changing the formula or factory without filing the required change or new notification.
• Treating different formulas as variants; only colour, fragrance or flavour differences qualify.
• Missing the whitening rule: NPRA’s FAQ asks for a certificate of analysis within one month of notifying a whitening product.
• Assuming Malaysia covers ASEAN; each country needs its own notification.

FAQ

What is NPRA?

NPRA, the National Pharmaceutical Regulatory Agency, is the Ministry of Health agency that regulates medicines and health supplements and receives cosmetic notifications for the Director of Pharmaceutical Services. For cosmetics it screens notifications, inspects local manufacturers for GMP and runs post-market surveillance.

How long does NPRA cosmetic notification take?

NPRA states the notification number is generated within 1–3 working days after it confirms payment, for a complete submission. Screening queries add time until the holder replies, and document preparation usually takes longer than NPRA’s step.

How much does it cost to notify a cosmetic with NPRA?

RM50 for each product and each variant, and RM50 at every two-yearly renewal. The holder also needs a Quest3+ membership (RM260 for one year or RM290 for two for the main user). Testing and safety assessment are charged separately.

Can my manufacturer hold the notification for my brand?

Yes, with your Letter of Authorisation. Because a change of manufacturer requires a new notification, brands planning to scale usually hold notifications through their own Malaysian company.

How can I check whether a cosmetic is notified?

Use NPRA’s public Quest3+ product search by product name, notification number, holder or manufacturer. Notification numbers follow the format NOT, year and month, serial number, then K.

Should the notification number be printed on the label?

No. NPRA’s FAQ says that since 1 January 2008 the notification number is not printed on labels. The holder can give buyers a copy of the Notification Note as proof.

Sources & references

• NPRA — Guidelines for Control of Cosmetic Products in Malaysia (Second Edition) — Regulation 18A, CNH and variant definitions
• NPRA — Section 2: Cosmetic Notification — holder duties, fees, validity, changes, NOT format
• NPRA — Section 3: Regulatory Requirements — particulars, Annexes, Halal logo, GMP inspection, PIF
• NPRA — Section 4: Post-Market Surveillance — surveillance and sampling
• NPRA — Section 5: Regulatory Action — rejection, cancellation, recall
• NPRA — FAQs — 1–3 working days, no prior approval, NOT number off labels, manufacturer changes, whitening, ASEAN
• NPRA — Annex I, Part 3 — Quest membership charges
• NPRA — Annex I, Part 7 — label particulars, 30-month expiry rule
• NPRA — Annex I, Part 8 — five-step test, unacceptable claims
• NPRA — Annex I, Part 13 — PIF format and retention
• NPRA — Quest3+ product search — Dr Orizi manufacturer count, checked 12 October 2026

Update history: October 2026 — first published.

Planning a cosmetic launch in Malaysia? See how our regulatory affairs support works alongside cosmetic OEM manufacturing, or send us your product list and intended claims to plan the notifications.