Notification only can be made on-line through QUEST online . All applicants must register for an access to Quest 3+ online system. After having an access to this system, applicant should properly fill in the Notification Form (available for reference in Annex 1 part 3, Guidelines for Control of Cosmetic Products in Malaysia ) and to complete the process until payment submission. Notification number is to be generated within 1-3 working days after payment confirmation by NPRA to enable printing of the Notification Note by the applicant themselves. This Notification Note will serve as the authorization to market, import, manufacture and wholesale cosmetic products. A separate wholesale authorization is required for a wholesaler which do not directly notify, manufacturer or import the product.

As for imported product, it can be handled by more than one importer provided that they are authorized by the responsible company. Since that Notification Note can only be printed by the responsible company who notify their product with NPRA, it is under the total control of that particular company to issue a copy of the Notification Note to the interested party.

The processing fee is RM50.00 for each product and each variant (if any). Notification shall be valid for 2 years and renewal should be done no later than 1 month prior to expiry together with the processing fee.

It will depend on the types of changes involved, as indicated in the table below:

Types of Change	Product Notification
Brand name	New Application
Company change due to change of distribution rights	Amendment on USB Token
Product types	Type 1 Notification Changes
Product presentation(single product, palettes in a range, etc)	Type 1 Notification Changes
Product name	Type 2 Notification Changes
Formulation	Type 2 Notification Changes
Manufacturer and or assembler (name and/or address)	Type 2 Notification Changes
Name and/or address of company without change of distribution rights	Amendment on USB Token
Person representing company	Amendment on USB Token
Label	Type 1 Notification Changes

A primary assembler is a company which is engaged in a process of enclosing the product in a primary/intermediate container which is labeled or to be labeled before the product is sold or supplied in it. This activity is basically involved filling process of a final formulation into finish product container.

A secondary assembler is a company which is engaged only in a process of labeling the product container where the product is already enclosed in its primary container and/or packing the product which already enclosed its label primary container into a carton which is labeled or to be labeled, before the product is sold or supplied.

Both processes are conducted by other than the manufacturer. All measures to ensure product safety and quality have to be taken into consideration by the assemblers.

Note: If finish product is released and labeled by same manufacturer, applicant is reminded not to simply add-in/ fill-in the field for assembler in the Notification Form.

Products which not meant for local market are exempted from notification requirement as they will not impact the safety of local consumers. However, prior approvals from the DPS must be obtained for such activities. The company should maintain proper records and documents and all these records should be made available for the inspection by the regulatory authorities at any time when required.

Country specific requirements for manufacturers or importers of cosmetic products meant solely for export of re-export must be complied with.

Yes. The authority of each country where the product is going to be marketed has to be informed individually.

Yes. As from 1 January 2008, notification number is not to be printed on the product label.

Notification system emphasized more on the self-regulation to the industry. The company is fully responsible to for the safety and quality of cosmetic products placed in the market. The company should take all necessary steps to understand fully and comply with all the requirements as stated in the Guidelines for Control of Cosmetic Products in Malaysia . Thus, prior approval by the authority is no longer applicable when this new system is implemented. As such, local players should be aware of this new ruling. As for overseas market, a confirmation towards compliance to the cosmetic GMP guidelines will be considered to be given by NPRA for export purpose.

PIF or Product Information File consist of a set of document concerning technical and safety information as required in Article 8 of the ASEAN Cosmetic Directive. This information should be made readily accessible for inspection by the cosmetic regulatory authority. The recommended format for the PIF can be found in Annex 1, Part 5: Guidelines for Control of Cosmetic Products in Malaysia .

The company or person responsible for placing the cosmetic product in the market (the one who notify NPRA) shall keep the PIF readily accessible to the regulatory authority at the address specified on the label. This clearly refers to a company or person having an address in the local market and to the company or person responsible for bringing in the product into the market; whether this is an importer, a manufacturer or a distributor.

For a cosmetic product manufactured by multiple manufacturers, product is to be notified under one notification submission. However, please note that changes to a notified product may require new notification. Thus, additional, substitution or changes in manufacturers? details shall require new notification.

A whitening product is categorized by its intended use and formula. As part of the Post Market Surveillance (PMS) activity, the applicant is required to submit the Certificate of Analysis (COA) to NPRA in one month period after product being notified. This COA is to be handed manually to NPRA for assessment and compilation. Since that the authority did found quite a number of product being adulterated with unauthorized substance such as Hydroquinone, Tretinoin, etc. in skin whitening preparation, the test result given in that certificate will serve as an additional confirmation that the product does not contain such item and products already complies to the regulation as stipulated in local laws.

All cosmetic products must be notified with the NPRA before it can be marketed in Malaysia . A foreign company wishing to bring cosmetic products into Malaysia would first have to appoint a local agent (a company registered in Malaysia ) to be the holder. The appointed agent would then be responsible for all matters pertaining to the notification of the products.

The company or person responsible for placing the cosmetic product in the market shall report to the regulatory authority of the ASEAN Member State where the adverse event occurred, regardless of the source of the report (consumer, healthcare professional, etc.)

All serious adverse events should be reported. Non-serious adverse events are not required to be reported. Whenever there is reasonable suspicion that the cosmetic product might be cause of the reaction, reporting is necessary for all serious adverse events.

Existing cosmetic product is a product registered with NPRA before 1 January 2008 . This product is not to be notified as new until its registration validity period is expired. As for renewal, new notification is to be submitted one (1) month prior to registration expiry date.

Label of existing product carrying the registration number (e.g. MAL12345678K) is still allowed to be in the local market until end of 2010 (as in Article 12, no. 2 of the ASEAN Cosmetic Directive (ACD): Member states may, however, for a period of 36 months from effective of the Directive, authorize the marketing in their territory of cosmetic products, which do not conform to the requirements of the Directive).

To enable printing of the Notification Note, registration number (MAL no.) had been automatically change to notification number (NOT no.) by the system.