MALAYSIA · COSMETICS

Malaysia Cosmetic CNH and Importer Arrangements: Authorisation, Distributor Changes and Renewals

In Malaysia, the Cosmetic Notification Holder (CNH) can be a different party from the product owner, importer and distributor. An overseas brand can authorise an eligible local CNH and work with designated import channels. Changing only the importer or distributor is not the same type of change as replacing the notifying company. The former is usually handled as a Type 1 amendment; replacing the company because of a change in distribution rights is a Type 2 change requiring a new notification. (Source: NPRA list of changes)

Who are the CNH, product owner, importer and distributor?

The CNH is the notification holder responsible for the product on the Malaysian market; it does not necessarily own the brand or product. NPRA states that the CNH may or may not be the product owner. (Source: NPRA Cosmetic Notification Process, 2024, p. 4)

One company can hold several roles, but a notification does not prove brand ownership and does not replace the commercial authorisations between the parties.

Can an overseas brand appoint a local CNH?

This arrangement can be assessed. NPRA requires the CNH to be a company or legal entity established in Malaysia, engaged in the cosmetics business, with a fixed address and SSM registration. The brand should check eligibility first and then define the scope of authorisation. (Source: NPRA: who may apply)

The QUEST manual explains that a letter of authorisation from the product owner can authorise the CNH to notify the listed products and brands and handle related notification matters. (Source: QUEST manual, p. 16)

Before signing, define the product scope, term of authorisation, document supply, confidentiality and termination handover. When discussing a CNH arrangement with MediPass, the responsible entity and service duties should also be set out in writing, so that regulatory maintenance and exclusive distribution rights are not bundled into one vague authorisation.

How can a CNH work with one or more designated importers?

The QUEST manual listed in NPRA’s current guideline index has separate importer and distributor fields on page 11, and states that the applicant should enter the details of one or more appointed importers. This provides an operational basis for a CNH and designated importers to be different parties — but it does not mean that any company outside the arrangement can import under the notification. (Source: QUEST manual, p. 11)

For each shipment, check three things: does the importer match the declared arrangement; do the product name, formula and label version match; and can the batch number, quantity and destination be reported back to the CNH? The manufacturer provides technical and batch documents, the importer provides arrival information, and the CNH coordinates the regulatory records. Customs and other applicable import conditions must be checked separately.

Does changing the importer or distributor require a new notification?

NPRA’s Type 1 list includes changes to the importer/distributor, authorisation documents and product label. Where only such changes occur, the existing notification can be amended and the original number kept — which is not the same as “no submission needed”. (Source: NPRA Annex I Part 5)

For example, if the CNH and product stay the same and only Importer A is replaced by Importer B, prepare an amendment reflecting the actual change. If the manufacturer, product name or formula also changes, all changes must be classified together. Before the business team fixes a switchover date, the regulatory team should receive the full list of changes.

Why does a change of CNH or distribution rights need separate assessment?

Replacing the notifying company because of a change in distribution rights is Type 2 and requires a new notification. Where the company name or address changes but distribution rights do not, the official list directs the company to contact the designated regulatory coordination unit; do not simply apply the channel-change route. (Source: NPRA list of changes and notes)

When changing CNH, plan the handover of old and new authorisations, PIF access, label responsibility details, existing stock and complaint records. NPRA also requires written notice when a CNH authorisation ends, and reasons when a notification is withdrawn. (Source: NPRA notification requirements, Section 2.2)

A brand that wants channel flexibility should therefore agree exit and handover terms in the first authorisation, rather than chasing technical documents and notification records when the relationship ends.

Who maintains the PIF, labels and ongoing compliance?

The CNH must ensure the Product Information File (PIF) is available to NPRA and keep product information up to date. NPRA’s PIF guideline requires access to be arranged at the address on the label; for confidential business information, the CNH and product owner can agree in advance that the owner will supply it directly to NPRA on request. (Source: NPRA PIF guideline, Sections 3 and 4.4)

A notification is valid for two years, and renewal should be completed no later than one month before expiry. Keep expiry dates, authorisation terms and channel contract periods in one maintenance calendar; the CNH must also keep distribution records and coordinate recalls and serious adverse event reporting. (Source: NPRA notification requirements, Sections 2.2 and 2.7)

Label information must be in Bahasa Malaysia and/or English, and product claims must be supported. When packaging or e-commerce copy changes, check the label, claims and file together — not just whether the notification number is still valid. (Source: NPRA regulatory requirements) For a document checklist, see How to Prepare an ASEAN Cosmetic PIF.