1. What is cosmetic product notification?
The company or person responsible for placing a cosmetic product in the local market must notify the Director of Pharmaceutical Services (DPS) through the National Pharmaceutical Control Bureau (NPCB) prior to market, manufacture or import a cosmetic product. This notification process will allow the NPCB to gather adequate information on the cosmetic products that are placed in the local market.
It is an offence for anyone to manufacture or import a cosmetic product without prior notification to the DPS.
2. Who should notify the authority?
The company or person responsible for placing a cosmetic product in the market is responsible for notifying the Director DPS prior to manufacture, import, supply by wholesale or sale of the products. A letter of authorization from the product owner is required if the company or person notifying does not own the product. The company must be registered with Syarikat Suruhanjaya Malaysia (SSM) or Malaysian Registrar of Business (ROB).
3. How to notify my product and how long does it take before product is allowed to be marketed? What is the document given to prove that my product has been notified with NPCB?
Notification only can be made on-line through NPCB website www.bpfk.gov.my/Quest2 . All applicants must register for an access to Quest2 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 days after payment confirmation by NPCB 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 NPCB, it is under the total control of that particular company to issue a copy of the Notification Note to the interested party.
4. How much is the processing fee and how long does the notification given is consider valid?
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.
5. If there are any changes in the information submitted in a product notification, do I have to file a new product notification?
It will depend on the types of changes involved, as indicated in the table below:
|Types of Change||Product Notification|
|Company change due to change of distribution rights||New|
|Product presentation(single product, palettes in a range, etc)|
|Manufacturer and or assembler (name and/or address)||New|
|Name and/or address of company without change of distribution rights||Amendment|
|valign="top"Person representing company||Amendment|
|Pack sizes, packaging materials, labels.||Amendment, but not applicable if the information need not be submitted in Product Notification Form.|
6. What are primary assembler and secondary assembler? What is the different for both assemblers?
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.
7. If we want to produce product for export only or import product solely for re-export, do we need to notify with NPCB?
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.
8. If the product already notified in Malaysia , do we need to notify again in other ASEAN countries?
Yes. The authority of each country where the product is going to be marketed has to be informed individually.
9. With the implementation of notification procedure, notification number will be issued instead of registration number. However, the labeling requirements do not include notification number. Does it mean that notification number is not required to be printed on the label?
Yes. As from 1 January 2008, notification number is not to be printed on the product label.
10. Manufacturing license is no longer issued by NPCB for cosmetic product. What can I do to convince both my local and overseas client that our manufacturing premise already comply to ASEAN GMP Guidelines for Cosmetic Products?
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 NPCB for export purpose.
11. What is Product Information File (PIF)?
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 .
12. Who should prepare and keep the PIF?
The company or person responsible for placing the cosmetic product in the market (the one who notify NPCB) 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.
13. If we have more than one manufacturer, do we need to submit under one application or separate form?
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.
14. What are the criteria for the whitening product? Is there any extra measures that applicant has to be aware of?
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 NPCB in one month period after product being notified. This COA is to be handed manually to NPCB 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.
15. How can an overseas company notify and distribute cosmetic products in Malaysia?
All cosmetic products must be notified with the NPCB 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.
16. Who should report the Adverse Events and what should be reported?
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.
17. What is existing cosmetic product?
Existing cosmetic product is a product registered with NPCB 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.