Brunei Cosmetics Regulation

In Brunei Darussalam (one of the ASEAN member states), cosmetic products are regulated by the Medicines (Cosmetic Products) Regulations, 2007 (the Regulations), which is in line with the ASEAN Cosmetic Directive (ACD). The Brunei Darussalam Medicines Control Authority (BDMCA) through the Director of Pharmaceutical Services is the Authority for the implementation of the Regulations in Brunei Darussalam. On 3 June 2008, with the commencement of the Regulations, all importers or manufacturers must notify the Authority before placing the cosmetic product in the local market. All cosmetic products must comply with the Regulations by 1 January 2011.

Prior to notifying the authority, the importer and manufacturer must meet relevant requirements. The importer, if he is an individual, must be registered under the Business Names Act and must hold a Brunei Darussalam Identity Card and be based in Brunei Darussalam, possesses adequate knowledge and complies with all regulations specified by the Authority. If he appoints a representative, the representative must meet the above criteria. The importer who is a company must be incorporated and registered under the Companies Act. As for the manufacturer, he must comply with the ASEAN Guidelines on Good Manufacturing Practice (GMP) for cosmetics.

The importer or manufacturer of the cosmetic products must notify the Authority before placing the cosmetic product in the local market using the prescribed Cosmetic Product Notification Form. The cosmetic product can only be marketed after receiving the notification acknowledgement letter from the Authority.

In addition, the importer or manufacturer must:

  • keep the product’s technical and safety information i.e. Product Information File (PIF) readily accessible to the Authority for auditing purposes;
  • keep records of importation, distribution and sale of the cosmetic products ready for auditing purposes;
  • have proper complaints management procedures and reporting of defects and adverse events to the Authority;
  • ensure that their cosmetic product complies with the safety and quality requirements;
  • ensure that each consignment of the product meets the requirements of the Authority and will not cause damage to human health under normal or reasonably foreseeable conditions of use.

A cosmetic product may be withheld from sale and supply and withdrawn from the market by the Authority if the product is suspected or found to cause damage to human health when applied under normal or reasonably foreseeable conditions of use. The Authority also has the right to suspend or cancel any Cosmetic Product Notification if the cosmetic product is suspected and / or found to cause damage to human health.

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