ASEAN SECTORAL INTEGRATION PROTOCOL FOR HEALTHCARE The Governments of Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People s Democratic Republic (hereinafter referred to as Lao PDR ), Malaysia, the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Viet Nam, Member States of the Association of South East Asian Nations (hereinafter collectively referred to as ASEAN or Member States or singularly as Member State ); RECALLING the Declaration of ASEAN Concord II (Bali Concord II) issued in Bali, Indonesia on 7 October 2003, pursuant to which ASEAN is committed to deepen and broaden its internal economic integration and linkages with the world economy to realise an ASEAN Economic Community; DESIRING that the ASEAN Economic Community will result in ASEAN becoming a single market and production base, turning the diversity that characterises the region into opportunities and business complementation to make ASEAN a more dynamic and stronger segment of the global supply chain; NOTING that as a first step towards the realisation of the ASEAN Economic Community, the Leaders have signed the ASEAN Framework Agreement for the Integration of Priority Sectors on 30th November 2004 in Vientiane, Lao PDR (hereinafter referred to as the Framework Agreement ); HAVING carried out an initial round of negotiations and concluded the roadmap for the full integration of the healthcare sector in ASEAN, HAVE AGREED AS FOLLOWS: ARTICLE 1 OBJECTIVE The objective of this Protocol is to spell out measures as in the Roadmap referred to in Article 2 to be taken by Member States on a priority basis so as to enable the progressive, expeditious and systematic integration of the healthcare sector. ARTICLE 2 MEASURES 1. The integration measures to be pursued are grouped into two broad categories, taking into account existing agreements or earlier relevant committed measures, namely: (a) Common measures which cut across all priority sectors; and (b) Specific measures that are of direct relevance to the healthcare sector. 2. All categories of measures shall be pursued in parallel. 3. SEOM may conduct additional negotiations, as and when necessary, to consider new integration measures for the sector. ARTICLE 3 EMERGENCY MEASURES 1. Article 6 of the Common Effective Preferential Tariff (CEPT) Agreement on Safeguard Measures shall be applied to this Protocol. 2. Where emergency measures are taken pursuant to this Article, immediate notice of such action shall be given to the Ministers responsible for ASEAN economic integration referred to in Article 19 of the Framework Agreement, and such action may be the subject of consultations pursuant to Article 22 of the Framework Agreement.
ARTICLE 4 APPENDICES 1. The Roadmap for Integration of Healthcare Sector shall be Appendix I to this Protocol and shall form an integral part of it. The negative list in relation to the healthcare sector shall be Appendix II to this Protocol. 2. Additional measures other than those identified in the Appendix I may be introduced, as and when deemed necessary through an amendment pursuant to paragraph 2 of Article 5 of this Protocol. ARTICLE 5 FINAL PROVISIONS 1. Member States shall undertake the appropriate measures to fulfill the agreed obligations arising from this Protocol. 2. The provisions of this Protocol may be modified through amendments mutually agreed upon in writing by all Member States. 3. This Protocol shall enter into force on 31 August 2005. Notwithstanding the specified date of entry into force, Member States undertake to carry out the obligations which arise prior to the date of entry into force of this Protocol in accordance with the timelines indicated in the Framework Agreement for the Integration of Priority Sectors and the Roadmap for Integration of Healthcare Sector attached to this Protocol. 4. This Protocol shall be deposited with the Secretary-General of ASEAN, who shall furnish a certified copy to each Member State. IN WITNESS WHEREOF, the undersigned, being duly authorised thereto by their respective Governments, have signed the ASEAN Sectoral Integration Protocol for Healthcare. DONE at Vientiane, Lao PDR on 29 November 2004, in a single copy in the English language. For the Government of Brunei Darussalam ABDUL RAHMAN TAIB Minister of Industry and Primary Resources For the Government of the Kingdom of Cambodia CHAM PRASIDH Senior Minister Minister of Commerce For the Government of the Republic of Indonesia MARI ELKA PANGESTU Minister of Trade For the Government of the Lao People s Democratic Republic SOULIVONG DARAVONG Minister of Commerce For the Government of Malaysia RAFIDAH AZIZ Minister of International Trade and Industry For the Government of the Union of Myanmar SOE THA Minister of National Planning and Economic Development
For the Government of the Republic of the Philippines CESAR V. PURISIMA Secretary of Trade and Industry For the Government of the Republic of Singapore LIM HNG KIANG Minister for Trade and Industry For the Government of the Kingdom of Thailand WATANA MUANGSOOK Minister of Commerce For the Government of the Socialist Republic of Vietnam TRUONG DINH TUYEN Minister of Trade I. OBJECTIVES APPENDIX I ROADMAP FOR INTEGRATION OF HEALTHCARE SECTOR The objectives of this initiative are to: - Strengthen regional integration through liberalisation and facilitation measures in the area of trade in goods, services and investments; and - Promote private sector participation. II. MEASURES The initiatives within incorporate recommendations in the Bali Concord II as well as those gathered from private and public sector representatives from all ASEAN countries. Full implementation of these recommendations is key for ASEAN to achieve our goal of integrating the healthcare sector by 2010. However they are not meant to be exhaustive, and ASEAN should continue to incorporate other necessary measures as and when appropriate. This roadmap includes issues specific to the Healthcare sector, as well as horizontal issues cutting across all sectors. III. COVERAGE The scope of product coverage for the healthcare sector appears as Attachment 1. NO. MEASURES IMPLEMENTING BODY TIMELINE I Tariff Elimination 1 Eliminate CEPT-AFTA tariffs on all identified products II Non-Tariff Measures (NTMs) COMMON ISSUES Coordinating Committee on the Implementation of the CEPT Scheme for AFTA (CCCA) ASEAN 6: 2007 CLMV: 2012 2 Establish the Database of ASEAN NTMs to ensure transparency 1 CCCA 30 June 2004 3 Establish clear criteria to identify 30 June 2005 1 The database on ASEAN NTMs has been completed and posted in the ASEAN Website.
measures that are classified as barriers to trade 4 Establish a clear and definitive work programme for the removal of the barriers. 6 Adopt the WTO Agreement on Import Licensing Procedures and develop implementation guidelines appropriate for ASEAN. III Rules of Origin 6 Improve the CEPT Rules of Origin by: IV - making it more transparent, predictable, standardised and tradefacilitating, taking into account the need to encourage regional sourcing and the best practices of other Regional Trade Agreements including the rules of origin of the WTO; and - adopting substantial transformation as alternative criteria for conferring origin status Customs Procedures 7 Extend the application of the ASEAN Harmonised Tariff Nomenclature (AHTN) for extra-asean trade 8 Develop a simplified, improved and harmonised customs declaration form 9 Ensure full implementation of the Green Lane System for CEPT Products, or similar systems, at entry points of all Member States 10 Develop implementation guidelines, as appropriate, for Member States which are not members of the WTO to fulfil the obligations of the WTO Agreement on Customs Valuation 11 Adopt service commitment (client charter) by ASEAN customs authorities 12 Develop the Single Window approach, including the electronic processing of trade documents at national and regional levels V Standards and Conformance Task Force on CEPT Rules of Origin (ROO- TF) Expert Committee on Customs Matters (ECCM) Inter-Agency Task Force on Single Window 31 December 2005 31 December 2004 31 December 2004 31 December 2005 31 December 2004 31 December 2004 31 December 2004 31 December 2005 13 Accelerate the ASEAN Consultative beginning 1 January 2005
implementation/development of sectoral Mutual Recognition Arrangements (MRAs), as appropriate 14 Encourage domestic regulators to recognise test reports issued by testing laboratories which are already accredited by National Accreditation Bodies in ASEAN that are signatories to ILAC and APLAC MRA 15 Set clear targets and schedules for harmonisation of standards, wherever required; where international standards are not available, and when requested by industry, align national standards among Member States 16 Harmonise and/or develop, wherever appropriate, technical regulations for national application. 17 Ensure compliance with the requirements, rights and obligations of WTO Agreements on Technical Barriers to Trade and the Application of Sanitary and Phyto-Sanitary Measures 18 Explore development of ASEAN policy on standards and conformance to further facilitate the realisation of the ASEAN Economic Community. VI Logistics Services 19 Expedite the development of integrated transport logistics services within ASEAN through: - Promotion of efficient door-to-door cargo transport and cross-border transport facilitation through the expeditious implementation of the ASEAN Framework Agreement on the Facilitation of Goods in Transit, and the ASEAN Framework Agreement on Multimodal Transport; - Improvement of land transport network infrastructures and services to achieve better inter- connectivity, inter-operability and inter-modality with the national, regional and international maritime and air transport gateways; Committee on Standards and Quality (ACCSQ) Senior Transport Officials Meeting (STOM) 31 December 2005 31 December 2010 beginning 2005 beginning 2005
VII - Strengthening intra-asean maritime and shipping transport services; and - Establishment of enabling and conducive policy environment for increased private sector involvement and/or public-private partnerships in the development of transport infrastructure and the provision and operation of transport logistics facilities and services Outsourcing and Industrial Complementation 20 dentify and develop specialisation of production processes, research and development (R&D), and testing facilities based on comparative advantages of individual Member States 21 Develop guidelines to promote outsourcing arrangements among Member States, as applicable VIII ASEAN Integration System of Preferences 22 Endeavour to simplify the procedures and expand the coverage of the ASEAN Integration System of Preferences (AISP) Scheme by including products in the priority integration sectors IX Investments Working Group on Industrial Cooperation (WGIC), with inputs from the private sector CCCA 23 Accelerate the opening up of sectors Coordinating Committee currently in the Sensitive List (SL) by on Investment (CCI) transferring these sectors into the Temporary Exclusion List (TEL) under the Framework Agreement on the ASEAN Investment Area, using the ASEAN-X formula 24 Reduce restrictive investment measures in the SL 25 Complete the progressive elimination of restrictive investment measures in the TEL 26 Identify and implement programmes and activities to promote investments in ASEAN 27 Promote manufacturing processes beginning 2004 beginning 2004 2 31 December 2005 2 Timelines in accordance with AIA Agreement (ASEAN-6 = 2010; Vietnam = 2013; Cambodia, Laos and Myanmar = 2015)
across different ASEAN countries to take advantage of their comparative strengths through: - the establishment of a network of ASEAN free trade zones to facilitate outsourcing activities - undertaking more efficient joint ASEAN facilitation and promotion measures to promote FDI 28 Promote and facilitate joint/cross border investments in manufacturing activities through: X - special incentives, where appropriate, to be given by CLMV for investments from ASEAN - special measures, where appropriate to be given by ASEAN 6 to promote and facilitate relocation of investment to CLMV countries especially for labour intensive manufacturing activities Trade and Investment Promotion 29 Intensify intra- and extra ASEAN joint promotion efforts regularly 30 Organise regular private sector initiatives to undertake: - more efficient joint ASEAN facilitation and promotion measures to promote FDI into ASEAN sellingbuying missions; and - promotional activities to assist CLMV countries 31 Undertake more effective joint ASEAN facilitation in promotion measures and develop new sources of inward foreign direct investments, particularly from potential countries such as the People s Republic of China, India and the Republic of Korea XI Intra-ASEAN Trade and Investment Statistics 32 Establish an effective system to monitor intra-asean trade and investment through: - provision of updates to the ASEAN CCI; ASEAN Chambers of Commerce and Industry (ASEAN- CCI); and relevant Industry Clubs/ Associations CCI; ASEAN Business Advisory Council (ASEAN-BAC); and ASEAN-CCI Working Group on Statistics; Working Group on Foreign Direct Investment Statistics; and CCCA beginning 2005 Ongoing beginning 2005
XII Secretariat of the latest trade (goods and services) and investment statistics - preparation of consolidated industry profile, by the respective associations, which among other matters, cover information such as production capacity and product range Intellectual Property Rights 33 Expand the scope of ASEAN intellectual property rights ASEAN Working Group on Intellectual Property cooperation beyond trademarks and Cooperation (AWGIPC) patents by including cooperation in copyrights information exchange and enforcement XIII Trade in Services 40 Member States shall accelerate the liberalisation of trade in services earlier than 2020. This could be achieved through: XIV - Setting clear targets and schedules of services liberalisation for each priority sector and each round towards achieving freer flow of trade in services by 2010; - Accelerating the development of Mutual Recognition Arrangements (MRAs); - The application of the ASEAN-X formula; and - Promotion of joint ventures and cooperation, including in third country markets. Coordinating Committee on Services (CCS) and CCI Movement of Business Persons, Experts, Skilled Labour, Talents and Professionals 35 Develop an ASEAN Agreement to facilitate the movement of business persons, including the adoption of an ASEAN Business Travel Card, taking into account Member States domestic laws and regulations 36 Develop an ASEAN Agreement to facilitate the movement of experts, professionals, skilled labor and talents, taking into account Member States' domestic laws and regulations Directors-General of Immigration Departments and Heads of Consular Affairs Division of the Ministries of Foreign Affairs (DGICM) 31 December 2004 before 2008 31 December 2005 CCS 31 December 2005
37 Accelerate completion of MRAs to facilitate free movement of experts, professionals, skilled labour and talents in ASEAN, taking into account Member States domestic laws and regulations XV Facilitation of Travel in ASEAN 38 Harmonise procedures for the issuance of visas to international travellers 39 Provide visa exemption for intra- ASEAN travel by ASEAN nationals XVI Human Resource Development 40 Develop and upgrade skills and capacity building through joint trainings and workshops XVII Investments 41 Allow higher share of ASEAN ownership / participation in selected healthcare establishments, subject to domestic laws and regulations of each ASEAN country, on an ASEAN-X basis 42 Set up "one-stop centre" in each ASEAN country responsible for facilitating investments, including healthcare projects XVIII Standards and Conformity Pharmaceutical Products 43 Study the feasibility of an ASEAN Mutual Recognition Arrangement (MRA) for pharmaceutical / medicinal products 44 Implement the ASEAN Common Technical Dossier 45 Harmonise the labelling standards for pharmaceutical/medicinal products 46 Explore the feasibility of adopting a harmonised placement system for pharmaceutical / medicinal products into the ASEAN markets 47 To facilitate the approval process, the ASEAN-X formula can be applied. The recognition of the approval proc- ess can only be 31 December 2008 DGICM 31 December 2004 Senior Labour Officials Meeting (SLOM) SPECIFIC ISSUES CCS and CCI 2005 CCI 31 December 2008 ACCSQ Pharmaceutical Product Working Group (PPWG) 30 December 2005 31 December 2008 31 December 2006 31 December 2009 after 31 December 2008
realised when Mem- ber States fully implement the ACTD 48 Explore the feasibility of implementing a flexible twinning system, where member states voluntarily pair with one or other member states to co- operate in enhancing mutual regulatory capacity and resource development 49 Formalise a post-marketing alert system for defective and unsafe pharmaceutical/medicinal products. Cosmetics 50 Accelerate implementation of the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS), and automatic listing for cosmetics products 51 Formalise a post-marketing alert system for defective or unsafe cosmetic products Medical Device and Equipment 52 Medical Device and Equipment Working Group to look into integration measures, which includes the following: - Developing a common submission dossier template for product approval in ASEAN - Exploring the feasibility of an abridged approval process for medical devices which regulators of benchmarked countries or recognised regional regulators have approved - Exploring the feasibility of adopting of a harmonised system of placement of medical devices into the ASEAN markets based on a common product approval process - Formalising of a post-marketing alert system for defective or unsafe medical devices or equipment - All ASEAN countries to consider joining the Asian Harmonisation Work Party (AHWP) and work in parallel with the Global Harmonisation Task Force (GHTF) on technical harmonisation efforts ACCSQ ASEAN Cosmetics Committee (ACC) ACCSQ Medical Device Product Working Group 31 December 2005 1 January 2008 31 December 2005 beginning 2005
53 Exchange, review and analyse information on the existing regulatory framework/regime including standard definition, terminologies, and technical infrastructure in Member Countries Traditional Medicines & Health Supplements ACCSQ Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) 31 December 2006 54 Identify areas for possible harmonisation and MRAs 55 Study the existing regulatory frameworks/regime of selected countries and internationally accepted technical guidelines 56 Enhance the technical infrastructure including mutual confidence in testing and conformity assessment 57 Formalisation of a post-marketing alert system for unsafe traditional medicine or health supplements XIX Capacity Building 58 More established ASEAN countries to provide training, pool training materials and host attachment programmes for medical and healthrelated workers from less developed ASEAN member states. 59 Provide more exchanges and training for medical and healthrelated professionals from less developed member states. This is especially necessary for areas of key shortages like specialists and skilled operators of medical equipment MRI and CT scanners 60 To strengthen cooperation within ASEAN countries in the area of capacity building, i.e., exchange of experts, regulatory infrastructure and human resource development, within available resources 61 Member states to consider modelling their technical standards and regulations after ASEAN harmonised technical standards and regulations which is to be evolved from acceptable international or regional technical standards and regulations. This lowers the cost of setting up Relevant ASEAN Professional Associations, e.g., ASEAN Association of Radiologists ACCSQ 31 December 2009 31 December 2006 2004 onwards 31 December 2007
XX regulations and is a step towards harmonisation of regulations within ASEAN Movement of Patients 62 Minimise visa requirements for intra- ASEAN travel by ASEAN nationals to facilitate cross border movement of patients and accompanying persons CCS and DGICM 31 December 2005 Attachment I Coverage of the Healthcare Products Sector No AHTN Description 1 1211.10.10 - - Cut, crushed or powdered form 2 1211.10.90 - - Other 3 1211.20.10 - - Cut, crushed or powdered form 4 1211.20.90 - - Other 5 1211.30.10 - - Cut, crushed or powdered form 6 1211.30.90 - - Other 7 1211.90.11 - - - Cannabis, in cut, crushed or powdered form 8 1211.90.12 - - - Cannabis, other form 9 1211.90.13 - - - Other, in cut, crushed or powdered form 10 1211.90.19 - - - Other 11 1211.90.91 - - - Pyrethrum, in cut, crushed or powdered form 12 1211.90.92 - - - Pyrethrum, other form 13 1211.90.93 - - - Cannabis 14 1211.90.94 - - - Sandalwood 15 1211.90.95 - - - Gaharu wood chips 16 1211.90.99 - - - Other 17 2936.10.00 - Provitamins, unmixed 18 2936.21.00 - - Vitamins A and their derivatives 19 2936.22.00 - - Vitamin B1 and its derivatives 20 2936.23.00 - - Vitamin B2 and its derivatives 21 2936.24.00 - - D- or DL-Pantothenic acid (Vitamin B3 or Vitamin B5) and its derivatives 22 2936.25.00 - - Vitamin B6 and its derivatives 23 2936.26.00 - - Vitamin B12 and its derivatives 24 2936.27.00 - - Vitamin C and its derivatives 25 2936.28.00 - - Vitamin E and its derivatives
26 2936.29.00 - - Other vitamins and their derivatives 27 2936.90.00 - Other, including natural concentrates 28 2937.12.00 - - Insulin and its salts 29 2937.19.00 - - Other 30 2937.21.00 - - Cortisone, hydrocortisone, prednisone (dehydrocortisone) and prednisolone (dehydrohydrocortisone) 31 2937.22.00 - - Halogenated derivatives of corticosteroidal hormones 32 2937.23.00 - - Oestrogens and progestogens 33 2937.29.00 - - Other 34 2937.31.00 - - Epinephrine 35 2937.39.00 - - Other 36 2937.40.00 - Amino-acid derivatives 37 2937.50.00 - Prostaglandis, thromboxanes and leukotrienes, their derivatives and structural analogues 38 3001.10.00 - Glands and other organs, dried, whether or not powdered 39 3001.20.00 - Extracts of glands or other organs or of their secretions 40 3001.90.00 - Other 41 3002.10.10 - - Plasma protein solution 42 3002.10.20 - - Antisera and modified immunological products whether or not obtained by means of biotechnological processes 43 3002.10.90 - - Other 44 3002.20.10 - - Tetanus toxoid 45 3002.20.20 - - Pertusis, measles, meningitis A/C, and polio vaccine 46 3002.20.90 - - Other 47 3002.30.00 - Vaccines for veterinary medicine 48 3002.90.00 - Other 49 3003.10.10 - - Containing amoxicillin (INN) or its salts 50 3003.10.20 - - Containing ampicillin (INN) or its salts 51 3003.10.90 - - Other 52 3003.20.00 - Containing other antibiotics 53 3003.31.00 - - Containing insulin 54 3003.39.00 - - Other 55 3003.40.10 - - Antimalarial 56 3003.40.90 - - Other 57 3003.90.10 - - Containing vitamins 58 3003.90.20 - - Containing analgesics or antipyretics, whether or not containing antihistamines
59 3003.90.30 - - Other preparations for the treatment of coughs and colds, whether or not containing antihistamines 60 3003.90.40 - - Antimalarial 61 3003.90.90 - - Other 62 3004.10.11 - - - Containing penicillin G or its salts (excluding penicillin G benzathin) 63 3004.10.12 - - - Containing phenoxymethyl penicillin or its salts 64 3004.10.13 - - - Containing ampicillin or its salts, for taking orally 65 3004.10.14 - - - Containing amoxycillin or its salts, for taking orally 66 3004.10.19 - - - Other 67 3004.10.21 - - - Ointment 68 3004.10.29 - - - Other 69 3004.20.11 - - - For taking orally 70 3004.20.12 - - - Ointment 71 3004.20.19 - - - Other 72 3004.20.21 - - - For taking orally 73 3004.20.22 - - - Ointment 74 3004.20.29 - - - Other 75 3004.20.31 - - - For taking orally 76 3004.20.32 - - - Ointment 77 3004.20.39 - - - Other 78 3004.20.41 - - - Containing gentamycines or derivatives thereof, for injection 79 3004.20.42 - - - Containing lincomycins or derivatives thereof, for taking orally 80 3004.20.43 - - - Ointments 81 3004.20.49 - - - Other 82 3004.20.51 - - - For taking orally 83 3004.20.52 - - - Ointments 84 3004.20.59 - - - Other 85 3004.20.60 - - Containing isoniazide, pyrazinamide or derivatives thereof, for taking orally 86 3004.20.90 - - Other 87 3004.31.00 - - Containing insulin 88 3004.32.10 - - - Containing hydrocortisone sodium succinate 89 3004.32.20 - - - Containing dexamethasone or its derivatives 90 3004.32.30 - - - Containing fluocinolone acetonide 91 3004.32.90 - - - Other 92 3004.39.10 - - - Containing adrenaline 93 3004.39.90 - - - Other
94 3004.40.10 - - Containing morphine or its derivatives, for injection 95 3004.40.20 - - Containing quinine hydrochloride or dihydrochloride, for injection 96 3004.40.30 - - Containing quinine sulphate or bisulphate, for taking orally 97 3004.40.40 - - Containing quinine or its salts and anti-malaria substances, other than goods of subheadings 3004.10 to 30 98 3004.40.50 - - Containing papaverine or berberine 99 3004.40.60 - - Containing theophylline 100 3004.40.70 - - Containing atropin sulphate 101 3004.40.90 - - Other 102 3004.50.10 - - Syrups and drops of vitamins, of a kind suitable for children 103 3004.50.20 - - Containing vitamins A, other than goods of subheading 3004.50.10 104 3004.50.30 - - Containing vitamins B1 or B2 or B6 or B12, other than goods of subheadings 3004.50.10 and 3004.50.20 105 3004.50.40 - - Containing vitamins C, other than goods of subheadings 3004.50.10, 3004.40.20 and 3004.50.30 106 3004.50.50 - - Containing vitamins PP, other than goods of subheadings 3004.50.10, 3004.50.20,3004.50.30 and 3004.50.40 107 3004.50.60 - - Containing other vitamins, other than goods of subheadings 3004.50.10, 3004.50.20, 3004.50.30, 3004.50.40 and 3004.50.50 108 3004.50.71 - - - Containing B complex vitamins 109 3004.50.79 - - - Other 110 3004.50.90 - - Other 111 3004.90.10 - - Specialised medicines for cancer, AIDS or other intractable diseases 112 3004.90.21 - - - Sodium chloride solution 113 3004.90.22 - - - 5% glucose solution 114 3004.90.23 - - - 30% glucose solution 115 3004.90.29 - - - Other 116 3004.90.30 - - Antiseptics 117 3004.90.41 - - - Containing procaine hydrochloride 118 3004.90.49 - - - Other 119 3004.90.51 - - - Containing acetylsalicylic acid, paracetamol or dipyrone (INN) 120 3004.90.52 - - - Containing chlorpheniramine maleate 121 3004.90.53 - - - Containing diclofenac 122 3004.90.54 - - - Analgesic balm oil, solid or liquid 123 3004.90.59 - - - Other 124 3004.90.61 - - - Containing artemisinin, artesunate or chloroquine (INN) 125 3004.90.62 - - - Containing primaquine 126 3004.90.69 - - - Other
127 3004.90.71 - - - Containing piperazine or mebendazole (INN) 128 3004.90.72 - - - Containing dichlorophen (INN) 129 3004.90.79 - - - Other 130 3004.90.80 - - Transdermal therapeutic systems (TTS) patches for cancer or heart diseases 131 3004.90.91 - - - Containing sulpiride (INN), cimetidine (INN), ranitidine (INN), aluminium hydroxide or magnesium hydroxide or orezol 132 3004.90.92 - - - Containing piroxicam (INN) or ibuprofen (INN) 133 3004.90.93 - - - Containing phenobarbital, diazepam, chlorpromazine 134 3004.90.94 - - - Containing salbutamol (INN) 135 3004.90.95 - - - Closed sterile water for inhalation, pharmaceutical grade 136 3004.90.96 - - - Containing o-methoxyphenyl glyceryl ether (Guaifenesin) 137 3004.90.97 - - - Nose-drop medicaments containing naphazoline, xylometazoline or oxymetazoline 138 3004.90.98 - - - Sorbitol 139 3004.90.99 - - - Other 140 3005.10.10 - - Covered or impregnated with pharmaceutical substances 141 3005.10.90 - - Other 142 3005.90.10 - - Bandages 143 3005.90.20 - - Gauze 144 3005.90.30 - - Gamgee 145 3005.90.90 - - Other 146 3006.10.00 - Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics 147 3006.20.00 - Blood-grouping reagents 148 3006.30.10 - - Barium sulfate (for taking orally) 149 3006.30.20 - - Reagents of microbial origin for veterinary biological diagnosis 150 3006.30.30 - - Other microbial diagnostic reagents 151 3006.30.90 - - Other 152 3006.40.10 - - Dental cements and other dental fillings 153 3006.40.20 - - Bone reconstruction cements 154 3006.50.00 - First-aid boxes and kits 155 3006.60.00 - Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides 156 3006.70.00 - Gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments
157 3006.80.00 - Waste pharmaceuticals 158 3303.00.00 Perfumes and toilet waters. 159 3304.10.00 - Lip make-up preparations 160 3304.20.00 - Eye make-up preparations 161 3304.30.00 - Manicure or pedicure preparations 162 3304.91.00 - - Powders, whether or not compressed 163 3304.99.10 - - - Face and skin creams and lotions 164 3304.99.20 - - - Anti-acne creams 165 3304.99.90 - - - Other 166 3305.10.10 - - Anti-mycosis shampoos 167 3305.10.90 - - Other 168 3305.20.00 - Preparations for permanent waving or straightening 169 3305.30.00 - Hair lacquers 170 3305.90.10 - - Brilliantines and other hair oils 171 3305.90.90 - - Other 172 3306.10.10 - - Prophylactic pastes and powders 173 3306.10.90 - - Other 174 3306.20.00 - Yarn used to clean between the teeth (dental floss) 175 3306.90.00 - Other 176 3307.10.00 - Pre-shave, shaving or after-shave preparations 177 3307.20.00 - Personal deodorants and antiperspirants 178 3307.30.00 - Perfumed bath salts and other bath preparations 179 3307.41.10 - - - Scented joss sticks 180 3307.41.90 - - - Other 181 3307.49.10 - - - Room perfuming preparations 182 3307.49.90 - - - Other 183 3307.90.10 - - Animal toilet preparations; other perfumery or cosmetics, including depilatories 184 3307.90.20 - - Contact lens solution 185 3307.90.30 - - Papers and tissues, impregnated or coated with perfume or cosmetics 186 3307.90.90 - - Other 187 3401.11.10 - - - Medicated products 188 3401.11.20 - - - Bath soap 189 3401.11.30 - - - Other, of felt or nonwovens, impregnated, coated or covered with soap or detergent 190 3401.11.90 - - - Other
191 3401.19.10 - - - Of felt or nonwovens, impregnated, coated or covered with soap or detergent 192 3401.19.90 - - - Other 193 3401.20.10 - - For flotation de-inking of recycled paper 194 3401.20.20 - - Soap chips 195 3401.20.90 - - Other 196 3401.30.00 - Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap 197 4014.10.00 - Sheath contraceptives 198 4818.40.10 - - Napkins and napkin liners for babies and similar sanitary articles 199 4818.40.20 - - Sanitary towels, tampons and similar articles 200 4818.50.10 - - Surgical face masks 201 4818.50.90 - - Other 202 5208.21.10 - - - Absorbent fabric for surgical use 203 6307.90.20 - - Surgical face masks 204 6307.90.90 - - Other 205 8419.20.00 - Medical, surgical or laboratory sterilisers 206 8713.10.00 - Not mechanically propelled 207 8714.20.11 - - - Of a diameter (including tyres) exceeding 75 mm but not exceeding 100 mm provided that the width of the wheel or tyre fitted thereto is not less than 30mm 208 8714.20.12 - - - Of a diameter (including tyres) exceeding 100 mm but not exceeding 250 mm provided that the width of the wheel or tyre fitted thereto is not less than 30 mm 209 8714.20.19 - - - Other 210 8714.20.20 - - Spokes 211 8714.20.30 - - Nipples 212 8714.20.90 - - Other 213 9001.30.00 - Contact lenses 214 9018.11.00 - - Electro-cardiographs 215 9018.12.00 - - Ultrasonic scanning apparatus 216 9018.13.00 - - Magnetic resonance imaging apparatus 217 9018.14.00 - - Scintigraphic apparatus 218 9018.19.00 - - Other 219 9018.20.00 - Ultra-violet or infra-red ray apparatus 220 9018.31.10 - - - Disposable syringes 221 9018.31.90 - - - Other
222 9018.32.00 - - Tubular metal needles and needles for sutures 223 9018.39.10 - - - Catheters 224 9018.39.20 - - - Disposable tubes for intravenous fluids 225 9018.39.90 - - - Other 226 9019.10.10 - - Electronic 227 9019.10.90 - - Other 228 9019.20.10 - - Artificial respiration apparatus 229 9019.20.90 - - Other 230 9021.10.00 - Orthopaedic or fracture appliances 231 9021.29.00 - - Other 232 9021.31.00 - - Artificial joints 233 9021.39.00 - - Other 234 9021.40.00 - Hearing aids, excluding parts and accessories 235 9021.50.00 - Pacemakers for stimulating heart muscles, excluding parts and accessories 236 9021.90.00 - Other 237 9022.12.00 - - Computed tomography apparatus 238 9022.13.00 - - Other, for dental use 239 9022.14.00 - - Other, for medical, surgical, or veterinary uses 240 9022.19.10 - - - X-ray apparatus for the physical inspection of solder joints on PCB/PWB assemblies 241 9022.19.90 - - - Other 242 9022.21.00 - - For medical, surgical, dental or veterinary uses 243 9022.29.00 - - For other uses 244 9402.90.10 - - Furniture specially designed for medical, surgical or veterinary surgical purposes and parts thereof 245 9402.90.90 - - Other Appendix II Negative List of ASEAN Member Countries for Healthcare Products Sector Brunei Darussalam No AHTN Description 1 3304.10.00 - Lip make-up preparations 2 3304.20.00 - Eye make-up preparations 3 3304.30.00 - Manicure or pedicure preparations 4 3304.91.00 - - Powders, whether or not compressed 5 3304.99.10 - - - Face and skin creams and lotions 6 3304.99.20 - - - Anti-acne creams
7 3304.99.90 - - - Other 8 3305.10.10 - - Anti-mycosis shampoos 9 3305.10.90 - - Other 10 3305.20.00 - Preparations for permanent waving or straightening 11 3307.10.00 - Pre-shave, shaving or after-shave preparations 12 3307.20.00 - Personal deodorants and antiperspirants 13 3307.30.00 - Perfumed bath salts and other bath preparations 14 3307.49.10 - - - Room perfuming preparations 15 3401.11.10 - - - Medicated products 16 3401.11.20 - - - Bath soap 17 3401.11.90 - - - Other 18 3401.19.90 - - - Other 19 3401.20.10 - - For flotation de-inking of recycled paper 20 3401.20.90 - - Other 21 3401.30.00 - Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap Cambodia No AHTN Description 1 3304.10.00 - Lip make-up preparations 2 3304.91.00 - - Powders, whether or not compressed 3 3304.99.10 - - - Face and skin creams and lotions 4 3305.10.10 - - Anti-mycosis shampoos 5 3305.10.90 - - Other 6 3305.30.00 - Hair lacquers 7 3305.90.10 - - Brilliantines and other hair oils 8 3305.90.90 - - Other 9 3306.10.10 - - Prophylactic pastes and powders 10 3306.10.90 - - Other 11 3306.90.00 - Other 12 3307.10.00 - Pre-shave, shaving or after-shave preparations 13 3307.20.00 - Personal deodorants and antiperspirants 14 3307.41.10 - - - Scented joss sticks 15 3307.41.90 - - - Other 16 3307.49.10 - - - Room perfuming preparations 17 3307.49.90 - - - Other 18 3401.11.10 - - - Medicated products
19 3401.11.20 - - - Bath soap 20 3401.11.90 - - - Other 21 3401.19.10 - - - Of felt or nonwovens, impregnated, coated or covered with soap or detergent 22 3401.19.90 - - - Other 23 3401.20.90 - - Other 24 4818.50.90 - - Other 25 6307.90.90 - - Other 26 8419.20.00 - Medical, surgical or laboratory sterilisers 27 9019.10.90 - - Other 28 9402.90.10 - - Furniture specially designed for medical, surgical or veterinary surgical purposes and parts thereof 29 9402.90.90 - - Other Indonesia No AHTN Description 1 1211.30.10 - - Cut, crushed or powdered form 2 1211.30.90 - - Other 3 1211.90.11 - - - Cannabis, in cut, crushed or powdered form 4 1211.90.12 - - - Cannabis, other form 5 1211.90.93 - - - Cannabis Lao PDR No AHTN Description 1 3303.00.00 Perfumes and toilet waters. 2 3304.10.00 - Lip make-up preparations 3 3304.20.00 - Eye make-up preparations 4 3304.30.00 - Manicure or pedicure preparations 5 3304.91.00 - - Powders, whether or not compressed 6 3304.99.10 - - - Face and skin creams and lotions 7 3304.99.20 - - - Anti-acne creams 8 3304.99.90 - - - Other 9 3305.10.10 - - Anti-mycosis shampoos 10 3305.10.90 - - Other 11 3305.20.00 - Preparations for permanent waving or straightening 12 3305.30.00 - Hair lacquers 13 3305.90.10 - - Brilliantines and other hair oils 14 3305.90.90 - - Other 15 3307.49.10 - - - Room perfuming preparations
16 3307.90.10 - - Animal toilet preparations; other perfumery or cosmetics, including depilatories Malaysia No AHTN Description 1 3304.91.00 - - Powders, whether or not compressed 2 3305.10.10 - - Anti-mycosis shampoos 3 3305.10.90 - - Other 4 3305.20.00 - Preparations for permanent waving or straightening 5 3305.30.00 - Hair lacquers 6 3305.90.10 - - Brilliantines and other hair oils 7 3305.90.90 - - Other 8 3306.10.90 - - Other 9 3306.20.00 - Yarn used to clean between the teeth (dental floss) 10 3307.49.90 - - - Other 11 3307.90.10 - - Animal toilet preparations; other perfumery or cosmetics, including depilatories 12 3307.90.20 - - Contact lens solution 13 3307.90.90 - - Other Myanmar No AHTN Description 1 1211.30.10 - - Cut, crushed or powdered form 2 1211.30.90 - - Other 3 1211.90.11 - - - Cannabis, in cut, crushed or powdered form 4 1211.90.12 - - - Cannabis, other form 5 1211.90.93 - - - Cannabis 6 1211.90.95 - - - Gaharu wood chips 7 3001.10.00 - Glands and other organs, dried, whether or not powdered 8 3001.90.00 - Other 9 3002.90.00 - Other 10 3003.40.90 - - Other 11 3003.90.90 - - Other 12 3004.10.21 - - - Ointment 13 3004.20.11 - - - For taking orally 14 3004.20.12 - - - Ointment 15 3004.20.21 - - - For taking orally 16 3004.20.22 - - - Ointment 17 3004.20.31 - - - For taking orally
18 3004.20.32 - - - Ointment 19 3004.20.42 - - - Containing lincomycins or derivatives thereof, for taking orally 20 3004.20.43 - - - Ointments 21 3004.20.51 - - - For taking orally 22 3004.20.52 - - - Ointments 23 3004.20.90 - - Other 24 3004.32.30 - - - Containing fluocinolone acetonide 25 3004.40.50 - - Containing papaverine or berberine 26 3004.40.90 - - Other 27 3004.50.50 - - Containing vitamins PP, other than goods of subheadings 3004.50.10, 3004.50.20,3004.50.30 and 3004.50.40 28 3004.50.60 - - Containing other vitamins, other than goods of subheadings 3004.50.10, 3004.50.20, 3004.50.30, 3004.50.40 and 3004.50.50 29 3004.50.90 - - Other 30 3004.90.23 - - - 30% glucose solution 31 3004.90.41 - - - Containing procaine hydrochloride 32 3004.90.54 - - - Analgesic balm oil, solid or liquid 33 3004.90.59 - - - Other 34 3004.90.71 - - - Containing piperazine or mebendazole (INN) 35 3004.90.72 - - - Containing dichlorophen (INN) 36 3004.90.80 - - Transdermal therapeutic systems (TTS) patches for cancer or heart diseases 37 3006.30.90 - - Other 38 3303.00.00 Perfumes and toilet waters. 39 3304.91.00 - - Powders, whether or not compressed 40 3304.99.10 - - - Face and skin creams and lotions 41 3305.10.10 - - Anti-mycosis shampoos 42 3305.90.10 - - Brilliantines and other hair oils 43 3306.10.10 - - Prophylactic pastes and powders 44 3306.10.90 - - Other 45 3307.10.00 - Pre-shave, shaving or after-shave preparations 46 3307.20.00 - Personal deodorants and antiperspirants 47 3307.41.10 - - - Scented joss sticks 48 3307.41.90 - - - Other 49 3401.11.10 - - - Medicated products 50 3401.11.20 - - - Bath soap 51 3401.11.30 - - - Other, of felt or nonwovens, impregnated, coated or covered with
soap or detergent 52 3401.11.90 - - - Other 53 6307.90.90 - - Other 54 9001.30.00 - Contact lenses 55 9018.31.10 - - - Disposable syringes 56 9018.31.90 - - - Other 57 9019.10.90 - - Other 58 9402.90.90 - - Other Philippines No AHTN Description 1 3401.11.10 - - - Medicated products 2 3401.11.20 - - - Bath soap 3 3401.11.30 - - - Other, of felt or nonwovens, impregnated, coated or covered with soap or detergent 4 3401.11.90 - - - Other 5 3401.19.10 - - - Of felt or nonwovens, impregnated, coated or covered with soap or detergent 6 3401.19.90 - - - Other 7 3401.20.20 - - Soap chips 8 3401.20.90 - - Other 9 3401.30.00 - Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap Thailand No AHTN Description 1 3004.10.19 - - - Other 2 3004.10.21 - - - Ointment 3 3004.10.29 - - - Other 4 3004.20.11 - - - For taking orally 5 3004.20.12 - - - Ointment 6 3004.20.21 - - - For taking orally 7 3004.20.22 - - - Ointment 8 3004.20.31 - - - For taking orally 9 3004.20.39 - - - Other 10 3004.20.41 - - - Containing gentamycines or derivatives thereof, for injection 11 3004.20.42 - - - Containing lincomycins or derivatives thereof, for taking orally 12 3004.20.43 - - - Ointments 13 3004.20.49 - - - Other
14 3004.20.51 - - - For taking orally 15 3004.20.52 - - - Ointments 16 3004.20.59 - - - Other 17 3004.20.60 - - Containing isoniazide, pyrazinamide or derivatives thereof, for taking orally 18 3004.20.90 - - Other 19 3004.32.10 - - - Containing hydrocortisone sodium succinate 20 3004.32.30 - - - Containing fluocinolone acetonide 21 3004.39.10 - - - Containing adrenaline 22 3004.39.90 - - - Other 23 3004.40.10 - - Containing morphine or its derivatives, for injection 24 3004.40.50 - - Containing papaverine or berberine 25 3004.40.90 - - Other 26 3004.50.79 - - - Other 27 3004.50.90 - - Other 28 3004.90.21 - - - Sodium chloride solution 29 3004.90.22 - - - 5% glucose solution 30 3004.90.23 - - - 30% glucose solution 31 3004.90.29 - - - Other 32 3004.90.49 - - - Other 33 3004.90.52 - - - Containing chlorpheniramine maleate 34 3004.90.53 - - - Containing diclofenac 35 3004.90.54 - - - Analgesic balm oil, solid or liquid 36 3004.90.59 - - - Other 37 3004.90.71 - - - Containing piperazine or mebendazole (INN) 38 3004.90.72 - - - Containing dichlorophen (INN) 39 3004.90.79 - - - Other 40 3004.90.91 - - - Containing sulpiride (INN), cimetidine (INN), ranitidine (INN), aluminium hydroxide or magnesium hydroxide or orezol 41 3004.90.92 - - - Containing piroxicam (INN) or ibuprofen (INN) 42 3004.90.93 - - - Containing phenobarbital, diazepam, chlorpromazine 43 3004.90.95 - - - Closed sterile water for inhalation, pharmaceutical grade 44 3004.90.96 - - - Containing o-methoxyphenyl glyceryl ether (Guaifenesin) 45 3004.90.97 - - - Nose-drop medicaments containing naphazoline, xylometazoline or oxymetazoline 46 3004.90.99 - - - Other 47 3303.00.00 Perfumes and toilet waters.
48 3304.10.00 - Lip make-up preparations 49 3304.20.00 - Eye make-up preparations 50 3304.30.00 - Manicure or pedicure preparations 51 3304.91.00 - - Powders, whether or not compressed 52 3304.99.10 - - - Face and skin creams and lotions 53 3304.99.20 - - - Anti-acne creams 54 3304.99.90 - - - Other 55 3305.10.10 - - Anti-mycosis shampoos 56 3305.10.90 - - Other 57 3305.20.00 - Preparations for permanent waving or straightening 58 3305.30.00 - Hair lacquers 59 3305.90.10 - - Brilliantines and other hair oils 60 3305.90.90 - - Other 61 3306.10.10 - - Prophylactic pastes and powders 62 3306.10.90 - - Other 63 3306.90.00 - Other 64 3307.10.00 - Pre-shave, shaving or after-shave preparations 65 3307.20.00 - Personal deodorants and antiperspirants 66 3307.30.00 - Perfumed bath salts and other bath preparations 67 3307.41.10 - - - Scented joss sticks 68 3307.41.90 - - - Other 69 3307.49.10 - - - Room perfuming preparations 70 3307.49.90 - - - Other 71 3307.90.10 - - Animal toilet preparations; other perfumery or cosmetics, including depilatories 72 3307.90.20 - - Contact lens solution 73 3307.90.30 - - Papers and tissues, impregnated or coated with perfume or cosmetics 74 3307.90.90 - - Other 75 3401.11.10 - - - Medicated products 76 3401.11.20 - - - Bath soap 77 3401.11.30 - - - Other, of felt or nonwovens, impregnated, coated or covered with soap or detergent 78 3401.11.90 - - - Other 79 3401.19.10 - - - Of felt or nonwovens, impregnated, coated or covered with soap or detergent 80 3401.19.90 - - - Other
81 3401.20.10 - - For flotation de-inking of recycled paper 82 3401.20.20 - - Soap chips 83 3401.20.90 - - Other 84 3401.30.00 - Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap 85 4818.40.10 - - Napkins and napkin liners for babies and similar sanitary articles 86 4818.40.20 - - Sanitary towels, tampons and similar articles 87 4818.50.10 - - Surgical face masks 88 4818.50.90 - - Other 89 9402.90.10 - - Furniture specially designed for medical, surgical or veterinary surgical purposes and parts thereof 90 9402.90.90 - - Other Viet Nam No AHTN Description 1 3003.10.10 - - Containing amoxicillin (INN) or its salts 2 3003.10.20 - - Containing ampicillin (INN) or its salts 3 3004.10.11 - - - Containing penicillin G or its salts (excluding penicillin G benzathin) 4 3004.10.12 - - - Containing phenoxymethyl penicillin or its salts 5 3004.10.13 - - - Containing ampicillin or its salts, for taking orally 6 3004.10.14 - - - Containing amoxycillin or its salts, for taking orally 7 3004.20.11 - - - For taking orally 8 3004.20.12 - - - Ointment 9 3004.20.21 - - - For taking orally 10 3004.20.22 - - - Ointment 11 3004.20.31 - - - For taking orally 12 3004.20.32 - - - Ointment 13 3004.20.41 - - - Containing gentamycines or derivatives thereof, for injection 14 3004.20.42 - - - Containing lincomycins or derivatives thereof, for taking orally 15 3004.20.43 - - - Ointments 16 3004.20.51 - - - For taking orally 17 3004.20.52 - - - Ointments 18 3004.20.60 - - Containing isoniazide, pyrazinamide or derivatives thereof, for taking orally 19 3004.32.30 - - - Containing fluocinolone acetonide 20 3004.50.20 - - Containing vitamins A, other than goods of subheading 3004.50.10 21 3004.50.30 - - Containing vitamins B1 or B2 or B6 or B12, other than goods of subheadings 3004.50.10 and 3004.50.20
22 3004.50.40 - - Containing vitamins C, other than goods of subheadings 3004.50.10, 23 3004.50.79 - - - Other 3004.40.20 and 3004.50.30 24 3004.90.21 - - - Sodium chloride solution 25 3004.90.22 - - - 5% glucose solution 26 3004.90.23 - - - 30% glucose solution 27 3004.90.51 - - - Containing acetylsalicylic acid, paracetamol or dipyrone (INN) 28 3004.90.52 - - - Containing chlorpheniramine maleate 29 3004.90.53 - - - Containing diclofenac 30 3004.90.54 - - - Analgesic balm oil, solid or liquid 31 3004.90.62 - - - Containing primaquine 32 3004.90.71 - - - Containing piperazine or mebendazole (INN) 33 3004.90.91 - - - Containing sulpiride (INN), cimetidine (INN), ranitidine (INN), aluminium hydroxide or magnesium hydroxide or orezol 34 3004.90.92 - - - Containing piroxicam (INN) or ibuprofen (INN) 35 3004.90.97 - - - Nose-drop medicaments containing naphazoline, xylometazoline or oxymetazoline 36 3005.10.10 - - Covered or impregnated with pharmaceutical substances 37 3005.90.10 - - Bandages 38 3005.90.20 - - Gauze 39 3005.90.30 - - Gamgee 40 3005.90.90 - - Other 41 5208.21.10 - - - Absorbent fabric for surgical use