First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta 13-15 November 2007 CHOO CHEOK HANG DEPARTMENT OF PHARMACEUTICAL SERVICES.

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Presentation transcript:

First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta November 2007 CHOO CHEOK HANG DEPARTMENT OF PHARMACEUTICAL SERVICES MINISTRY OF HEALTH BRUNEI DARUSSALAM

LEGISLATIVE INFRASTRUCTURE LAWS RELATING TO COUNTERFEIT GOODS - Emergency (Copyright) Order Emergency (Patent) Order Trademarks Act (Cap. 98) - Merchandise Marks Act (Cap.96) First ASEAN-China Conference on Combating Counterfeit Medical Products

LEGISLATIVE INFRASTRUCTURE REGULATIONS OF COUNTERFEIT MEDICINES - Trademark Act (Cap. 98) - Merchandise Marks Act (Cap. 96) First ASEAN-China Conference on Combating Counterfeit Medical Products

NATIONAL PLAN ON DRUG CONTROL - Medicines Order (Draft) - Drug Registration - Counterfeit Medicines First ASEAN-China Conference on Combating Counterfeit Medical Products

Definition: Counterfeit Medicines WHO definition: A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Brunei Darussalam: Counterfeit medicine means a medicine that is deliberately and fraudulently mislabelled with respect to its identity or source or both, whether it is a branded or a generic product; and may include products with correct ingredients or with incorrect ingredients, without active ingredients, with insufficient active ingredients or with false packaging. First ASEAN-China Conference on Combating Counterfeit Medical Products

NATIONAL COORDINATION CONTROL OF COUNTERFEIT MEDICINES - Co-operation with other Stake Holders - Co-operation with other Govt Agencies - RAPID ALERT SYSTEM & IMPACT First ASEAN-China Conference on Combating Counterfeit Medical Products

Complaints: Counterfeit Medicines - Panadol Tablets - Teh Orang Kampung - Zambuk Ointment First ASEAN-China Conference on Combating Counterfeit Medical Products

CONTROL OF COUNTERFEIT MEDICINES Legislation – Medicines Order Enforcement Pre-marketing quality assessment: (registration, licensing, marketing authorization) Post-marketing surveillance: (ensuring quality of medicines) Co-operation among other agencies: (Ministry of Health, Police & Customs) First ASEAN-China Conference on Combating Counterfeit Medical Products

Thank You! Terima Kasih!