Tool 1 · Route and file
Who files, what goes in, what NPRA checks.
Tick what you are sending to Malaysia. The file builds as you answer. Each line carries a tag for who acts (Brand, CNH, NPRA) and the paragraph it comes from. Print it for your importer.
Your Malaysia file
- ExemptExemptions need NPRA’s written approval.A locally registered company may make or import un-notified cosmetics for the purposes below, “subject to written approval by the DPS”. These goods may never be used for commercial sale. (§7)
- ExemptMarket sampling: one entry, not for sale.A one-time entry solely for test marketing or aesthetic studies, to see whether a potential group of consumers or manufacturers perceives the products well. Not for commercial sale. Application online through Quest. (§7.1; §7 application process (i))
- ExemptIn-house evaluation: pick, test or demonstrate.Samples from R&D or the production line, or actual products from the country of origin, evaluated by the company for product selection, in-house evaluation or demonstration. Not for commercial sale. Application online through Quest. (§7.2)
- ExemptExport-only or re-export: exempt, with records.Made locally solely for export (FEO), or imported only to be assembled, packed or labelled for re-export. Keep records ready for NPRA and meet the destination country’s rules. Apply by hard copy and e-mail: cover letter stating the purpose, product list (code, name, pack size, quantity, category) and, for FEO, the ingredient list (INCI, function, CAS, percentage). (§7.3)
- ExemptIn transit: no notification.Cosmetics brought into Malaysia by land, air or water, whether or not landed or transhipped, solely to be carried to another country, need no notification. The exemption application goes by hard copy and e-mail. (§7.4)
- ExemptFree-trade zone or international carriage: exempt, with records.Cosmetics imported for sale or supply in the free-trade zone, or on ships, aircraft or other international public transport entering or leaving Malaysia, are exempt. Keep records for inspection. Our reading: the day the goods go into the local market, the full route below applies. (§7.5)
- NPRANot a cosmetic: this route does not apply.A product meant to be ingested, injected or placed on the mucous membranes of the nose or internal genitalia cannot be a cosmetic. Nor can one presented as treating or preventing disease, or acting pharmacologically, immunologically or metabolically. Another regime applies, and this desk does not cover it. (Annex I part 8, decision steps 2, 4 and 5)
- CNHWho files: a Malaysian company, not the Korean brand.The Cosmetic Notification Holder (CNH) places the product on the market. It must be a locally incorporated company in the field of cosmetics, with a permanent address, registered with the Companies Commission of Malaysia (SSM), with a business scope related to health or cosmetic products in its memorandum and articles. It may or may not be the product owner. (Glossary; §2.1)
- CNHThe CNH needs a Quest membership first.Filing is online only, through NPRA’s Quest system, and NPRA approves or rejects each membership. The August 2022 price list sells a certificate and USB token: main user RM 260 for 1 year, RM 290 for 2 years. Ask your CNH for today’s price. (§2.3.1; Annex I part 3)
- CNHRM 50 a product, valid for 2 years.Processing fee RM 50 for each product (and variant, if any), not refundable once paid. A notification lasts 2 years; renew no later than 1 month before it expires, for another RM 50. A product not renewed in time needs a new notification and gets a new number. Count a range on the fees page. (§2.6, 2.7, 2.10)
- BrandThe facts the CNH will type into Quest.Product name, type, intended use and presentation; name and address of the manufacturer and any assembler; the CNH and its contact person; any importer; the full ingredient list; the label; the authorisation letter. (§3.1.1 to 3.1.8)
- BrandThe full formula, with percentages for restricted groups.INCI list of the finished product. The percentage of every substance that appears in Annexes III to VII (restricted substances, colourants, preservatives, UV filters) is mandatory in Quest. Annex II substances are banned, traces allowed only if technically unavoidable. NPRA’s annexes were re-issued in June 2026 (II, III, IV, VI) and December 2025 (VII); this desk does not screen ingredients. (§3.3; Annex I part 4 step 10)
- BrandThe Korean factory’s GMP certificate or equivalent.For a foreign manufacturer or primary assembler, Quest makes it mandatory to attach the GMP certificate or equivalent. The proof must be issued or endorsed by an authorised body in the country of manufacture. (Annex I part 4 step 7; §3.7)
- BrandA letter from the brand owner.If the CNH is not the owner, the owner issues a Letter of Authorisation listing the products or brands. If the CNH is the owner, it produces a Letter of Declaration of ownership of the brand, with the same list. (Glossary; Annex I part 4 section H)
- BrandMade by a contract factory: attach the contract letters.Contract appointment and acceptance letters between the product owner and the contract manufacturer, naming the products or brands and the role and responsibilities of each side. (Glossary; Annex I part 4 section H)
- BrandLabel artwork in Bahasa Malaysia and/or English.The label is uploaded in Quest. Information on the label must be in Bahasa Malaysia and/or English. Documents sent to NPRA follow the same rule, and translations from other languages must be endorsed or authorised. See the label sheet. (§2.4, 3.4; Annex I part 7 §5)
- BrandA safety assessment for each product.The CNH must ensure a safety assessment has been done for each product. In the Product Information File it is a signed report of the safety of the finished product, its ingredients, their chemical structure and level of exposure, with the assessor’s CV. Its format is in Annex I part 6, which this desk has not read. (§3.2; Annex I part 13)
- BrandA Product Information File at the address on the label.Four parts: administrative documents and product summary; quality data of raw materials; quality data of the finished product; safety and efficacy data. In Bahasa Malaysia or English, kept updated, readily accessible to NPRA at the address specified on the label. The CNH keeps it, but most of the content comes from you and your factory. (§3.8; Annex I part 13)
- NPRANPRA screens before it issues.Every submission is screened. Products with prohibited substances, restricted ones above the limit, or presented beyond the cosmetic scope are denied. NPRA’s market screening also looks at the product name and its claimed benefits. Run your wording through the word screen first. (§4.1.1, 5.1)
- CNHThe Notification Note is the licence to sell.When NPRA confirms payment and the requirements are met, the CNH prints the Notification Note from Quest. It authorises manufacture, import and sale; the number reads NOT, year, month, serial, K. This guideline describes no separate import permit; customs and other agencies are outside this desk. (§2.8, 2.10)
- NPRAAdverts follow the same claims rules.Advertising includes labels, leaflets and electronic media, in any form. It must not carry medicinal claims or claims beyond the cosmetic scope, must be capable of substantiation, and must not give an impression of professional endorsement (doctors, white coats, hospital settings) or exploit fear, superstition or religion. (Annex I part 10 §1.2, 3, 4.1, 4.3, 4.4)
- NPRAAfter launch: samples, label checks, PIF audits.NPRA may take a sample from the market or ask the CNH for one: same batch, unopened, in its marketed pack, at least 4 units and 40 g or ml in total, expiry not less than one year from delivery. Its test limits: mercury 1, lead 20, arsenic 5, cadmium 5 ppm; total viable count 1,000 cfu per g (500 for children under 3, the eye area and mucous membranes); no P. aeruginosa, S. aureus or C. albicans in 0.1 g. (§4.1, 4.2; Annex I part 14)
- NPRAA note can be cancelled, and recalls are ordered.The Director of Pharmaceutical Services may cancel a Notification Note at any time if the product fails the rules, and the CNH must recall and report as directed. Breaches are offences under Section 30(1) of the Control of Drugs and Cosmetics Regulations 1984. (§5.2 to 5.4)
- CNHChanges: label and importer are free, formula and name are not.Type 1 (amend the notification, no fee, same number): presentation, representative, importer or distributor, authorisation letters, labels. Type 2 (new notification, RM 50, new number): brand name, distribution-rights company, product type, intended use, product name, formulation, manufacturer or assembler. (§2.9; Annex I part 5)
- AlsoSunscreen: a separate guideline applies as well.Annex I part 9(i), “Guideline for Sunscreen Product”, which this desk has not read in full. Part 8 already rejects “sunblock”, “waterproof” and SPF above 50, and accepts SPF 50+. (§3.5)
- AlsoHand sanitiser and antibacterial wash: own guidelines.Annex I parts 9(ii) and 9(iii). Not covered by this desk. (§3.5)
- CheckHalal logo on the label: only with certification.The halal logo is voluntary, for local and export markets, provided JAKIM or an Islamic body recognised by JAKIM has certified and approved the product. No certificate, no logo. Check JAKIM’s current list of recognised foreign bodies. (§3.4)
- CheckAnimal-origin ingredients: say so on the label.A statement, in any format, must signal the presence of ingredients of animal origin. For bovine (cow) or porcine (pig) origin the exact animal must be declared. Think collagen, elastin, gelatin, placenta extract, snail mucin, lanolin. (Annex I part 7 §3.1(i))
- CheckAn ingredient word in the product name.A name may not use an ingredient as part of the product name if the product does not contain it. A name based on a characteristic of an ingredient is allowed. Use the word screen. (Annex I part 2)
- CheckAmpoule or vial: print “for external use only”.Products packaged in a vial or ampoule must be labelled “for external use only”. (Annex I part 7 §3.1(i))
- CheckUnder 30 months of durability: an expiry date is mandatory.An expiry date is mandatory for minimum durability under 30 months, preceded by “expiry date” or “best before”. The date is month and year, or day, month and year “in that order”. Our reading: a Korean year-month-day print does not fit that order. (Annex I part 7 §3.1(h))
- CheckA range with shades or scents: variants.Variants are items from the same manufacturer, similar in composition and for the same use, differing in colour, fragrance or flavour. “Palettes in a range” is a listed product presentation, so a range can sit under one notification. The fee wording says “each product (and variant, if any)”; see the fees page. (Glossary; §2.6; Annex I part 5)