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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 on theme: "First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta 13-15 November 2007 CHOO CHEOK HANG DEPARTMENT OF PHARMACEUTICAL SERVICES."— Presentation transcript:

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

2 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

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

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

5 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

6 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

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

8 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

9 Thank You! Terima Kasih!


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