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In order to realise the objective of free flow of goods under the first pillar of the ASEAN Economic Community (AEC), it is necessary to remove/reduce barriers to intra ASEAN trade. Different technical requirements for the placement of health supplements in the markets in different ASEAN Member States is one such barrier to intra ASEAN trade of health supplements. After more than a decade’s of hard work undertaken by the ASEAN Traditional Medicines and Health Supplements Products Working Group (TMHS PWG) and its dedicated scientific committee/GMP taskforce, the following 10 ASEAN harmonised technical requirements and standards for health supplements have been finalized and will be presented as technical annexes to the ASEAN Agreement on Regulatory Framework for Health Supplements which, upon signing by the ASEAN economic ministers and ratification, will be set for transposition into the national regulations of each ASEAN Member State within a specified timeframe.

Annex I– ASEAN Guiding Principles for Inclusion Into or Exclusion From the Negative List of Substances for Health Supplements

Annex II– ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements

Annex III – ASEAN Guidelines on Limits of Contaminants for Health Supplements

Annex IV – ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements

Annex V – ASEAN Guidelines on Stability and Shelf-Life of Health Supplements

Annex VI – ASEAN Guiding Principles on Safety Substantiation of Health Supplements

Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for Health Supplements

Annex VIII – ASEAN Guideline on Good Manufacturing Practice for Health Supplements

Annex IX – ASEAN Guidelines on Labelling Requirements for Health Supplements

Annex X – ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements

Members who are keen to receive a copy of above Annexes, please email to

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