GUIDING PRINCIPLES FOR THE LIST OF STATES

Transcription

1 Association of South East Asian Nations (ASEAN) GUIDING PRINCIPLES FOR THE LIST OF ACTIVE SUBSTANCES, THE USE OF WHICH IN TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS IS SUBJECT TO RESTRICTION IN AT LEAST ONE OF THE ASEAN MEMBER STATES Version 1.0

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3 DOCUMENT INFORMATION This version is adopted at XXth ASEAN TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS SCIENTIFIC COMMITTEE MEETING (ATSC) [Date, City, Country] and endorsed at the XXth ACCSQ TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS PRODUCT WORKING GROUP (TMHSPWG) MEETING [Date, City, Country] 1 of 5 Version 1.0-6/17/2013

4 CONTENTS Purpose...3 Guiding principles...3 Appendix...7 Appendix 1 LIST of Restricted Active Substances, the use of which in Traditional Medicines and Health Supplements is of 5 Version 1.0-6/17/2013

5 GUIDING PRINCIPLES FOR THE LIST OF ACTIVE SUBSTANCES, THE USE OF WHICH IN TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS IS SUBJECT TO RESTRICTION IN AT LEAST ONE OF THE ASEAN MEMBER STATES PURPOSE The ASEAN List for Traditional Medicines and Health Supplements (TMHS) contains active substances which are subject to specific restrictions for use in at least one of the ASEAN Member. The List serves as a reference document for regulatory authorities and TMHS industry. It has no legal or regulatory force in ASEAN Member and does not supersede the National regulations of respective Member. The List is prepared from the following guiding principles established to govern the changes to the List. GUIDING PRINCIPLES 1. This List should include: 1.1 Substances which, when administered beyond a certain limit, or when used outside the stipulated conditions, have been demonstrated / documented to be capable of causing harm to human health or having public health impact. 1.2 Substances which have restriction for use in at least one ASEAN Member State 3 of 5 Version 1.0-6/17/2013

6 2. A substance that qualifies for inclusion into the list should carry the following details but not limited to: 2.1. Identity of the substance Taxonomy classification e.g. scientific name by genus and species Common name/ traditional name 2.2. Source of the substance (e.g. natural / certain part or whole plant /animal) 2.3. Name of harmful compound(s), if known 2.4. Rationale for inclusion (e.g. harmful effects) 2.5. Supporting References for 2.3 and Restriction/Prohibition Status in ASEAN Member 2.7. Remarks (e.g. conditions of restricted use) 3. This List should not include: 3.1. Substances in the ASEAN List of Restricted Additives and Excipients for TMHS Nutrients with established ASEAN maximum limits (e.g. vitamins and minerals) Naturally occurring toxic contaminants that are within established limits (e.g. lead) stated in the ASEAN Limits of Contaminants Substances which are prohibited under existing wildlife protection laws of all member states Synthetic chemical substances. 4. The List is a living document subject to regular review. A Member State who has made changes to the use of an active substance, or to the condition of its restricted use in their country should notify the appointed scientific body so that the List could be updated accordingly. 4 of 5 Version 1.0-6/17/2013

7 5. Please refer Appendix 1 for the List of Active Substances, the use of which in Traditional Medicines and Health Supplements is subject to restriction in at least one of the ASEAN Member. 5 of 5 Version 1.0-6/17/2013

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9 which in traditional medicines and health supplements is APPENDIX Appendix 1 LIST OF RESTRICTED ACTIVE SUBSTANCES, THE USE OF WHICH IN TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS IS SUBJECT TO RESTRICTION IN AT LEAST ONE OF THE ASEAN MEMBER STATES 7 of 5 Version 1.0-6/17/2013