2017 ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports of Generic Medicinal Products

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Additional Annexes	2017-MRA-on-Bioequivalence-Annex-B.pdf
Full Title	2017 ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports of Generic Medicinal Products
Short Title / Abbreviations	ASEAN MRA on Bioequivalence (BE)
CIL Subject Classification	ASEAN Documents ASEAN Economic Community ASEAN Free Trade Area ASEAN Socio-Cultural Community Health
Date of Adoption	02/11/2017
Place of Adoption	Manila, the Philippines
Issued/Adopted by	Economic Ministers of ASEAN
Dispute settlement provisions	“ARTICLE 15: SETTLEMENT OF DISPUTES 1. Member States shall at all times endeavour to agree on the interpretation or implementation of this Sectoral MRA and shall make any attempt through communication, dialogue, consultation and cooperation to arrive at a mutually satisfactory resolution of any matter that might affect the implementation of this Sectoral MRA. 2. The ASEAN Protocol on Enhanced Dispute Settlement Mechanism, signed on 29 November 2004 in Vientiane, Lao PDR and amendments thereto, shall apply to disputes concerning the interpretation or implementation of any of the provisions under this Sectoral MRA.” This Arrangement is one of the ‘Covered Agreements’ pursuant to Article 1.1 of the 2019 ASEAN Protocol on Enhanced Dispute Settlement Mechanism read together with its Appendix 1.
Depository	Secretary-General of ASEAN
Annexes	Annex A: Scope of Application of the Sectoral MRA Annex B: ASEAN Guidline for the Conduct of Bioequivalence Studies Appendix I: Dissolution testing and similarity of dissolution profiles Appendix II: Bioequivalence study requirements for different dosage form Appendix III: BCS-based Biowaver Appendix IV: ASEAN Bioequivalence Study Reporting Format
Entry Into Force Status	In Force
Date of Entry into Force	02/11/2017
Entry into Force / Termination Provisions	“ARTICLE 19: ENTRY INTO FORCE This Sectoral MRA shall enter into force on the date of its signature.”
Status
ASEAN States	(Source: ASEAN Legal Instruments as of 23/09/2022)
Brunei Darussalam	Signature 02/11/2017
Cambodia	Signature 02/11/2017
Indonesia	Signature 02/11/2017
Lao PDR	Signature 02/11/2017
Malaysia	Signature 02/11/2017
Myanmar	Signature 02/11/2017
Philippines	Signature 02/11/2017
Singapore	Signature 02/11/2017
Thailand	Signature 02/11/2017
Vietnam	Signature 02/11/2017
Related Instruments
Related Instruments	1998 ASEAN Framework Agreement on Mutual Recognition Arrangements 2004 ASEAN Framework Agreement for the Integration of Priority Sectors 2004 ASEAN Sectoral Integration Protocol for Healthcare 2007 ASEAN Economic Community Blueprint 2009 ASEAN Trade in Goods Agreement 2015 ASEAN Economic Community Blueprint 2025
External Links	ASEAN Secretariat accessed on 23/09/2022