2009 ASEAN Sectoral Mutual Recognition Agreement on Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products

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Full Title	2009 ASEAN Sectoral Mutual Recognition Agreement on Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products
Short Title / Abbreviations	ASEAN Sectoral MRA on GMP Inspection of Manufacturers of Medicinal Products
CIL Subject Classification	ASEAN Documents ASEAN Economic Community ASEAN Economic Ministers ASEAN Free Trade Area ASEAN Socio-Cultural Community Health
Date of Adoption	10/04/2009
Place of Adoption	Pattaya, Thailand, 15th ASEAN Summit
Issued/Adopted by	Economic Ministers of ASEAN
Dispute settlement provisions	Article 17 ‘Dispute Settlement’: “The ASEAN Protocol on Enhanced Dispute Settlement Mechanism done at Vientiane, Lao PDR on 29 November 2004, shall apply to dispute concerning the interpretation, implementation, and/or application of any of the provision under this Sectoral MRA.” Article 11.3 ‘Implementation’: “If a Party decides not to accept the inspection report of a Listed Inspection Service, it shall provide the necessary clarification of its reasons to the Party whose Inspection Service had furnished the inspection report. Any dispute arising from the non-acceptance of an inspection report by a Listed Inspection Service shall be brought by the aggrieved Party to the JSC for deliberation, whose decision shall bind the Parties to the dispute.” 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. The 2019 Protocol will only apply with respect to new requests for consultations made on or after its entry into force (20 June 2022).
Depository	Secretary-General of ASEAN
Entry Into Force Status	In Force
Source	ASEAN Secretariat
Date of Entry into Force	10/04/2009
Entry into Force / Termination Provisions	Article 19.4 ‘Final Provisions’: “This Sectoral MRA shall enter into force on the date of its signature.”
Status
ASEAN States	(Source: ASEAN Legal Instruments as of 29/09/2022)
Brunei Darussalam	Signature 10/04/2009
Cambodia	Signature 10/04/2009
Indonesia	Signature 10/04/2009
Lao PDR	Signature 10/04/2009
Malaysia	Signature 10/04/2009
Myanmar	Signature 10/04/2009
Philippines	Signature 10/04/2009
Singapore	Signature 10/04/2009
Thailand	Signature 10/04/2009
Vietnam	Signature 10/04/2009
Related Instruments
This instrument amends/supersedes	1998 ASEAN Framework Agreement on Mutual Recognition Arrangements
Related Instruments	2004 ASEAN Framework Agreement for the Integration of Priority Sectors 2004 ASEAN Sectoral Integration Protocol for Healthcare
External Links	ASEAN Secretariat accessed on 29/09/2022
Additional Information	Note Article 19.3 ‘Final Provisions’: “Member States shall make no reservations with respect to any of the provisions of this Sectoral MRA.” Note Article 16 ‘Rights and Obligations under Existing International Agreements or Conventions’: “This Sectoral MRA or any actions taken thereto shall not affect the rights and obligations of any Party under any existing international agreements or conventions to which it is also a signatory or a party.” Note Article 15 ‘Confidentiality’: “1. Parties shall maintain, to the extent permitted under their national laws and regulations the confidentiality of information exchanged under this Sectoral MRA. 2. Parties shall take all reasonable and necessary precautions to protect information exchanged under this Sectoral MRA from unauthorised disclosure. 3. An importing Party shall not require the designated Inspection Service of an exporting Party to disclose a manufacturer’s proprietary information, except to the extent necessary to demonstrate conformity with the importing Party’s mandatory requirements. 4. Parties agree that the provisions of this Article shall continue to be binding between the Parties notwithstanding the withdrawal or termination of a Listed Inspection Service in accordance to Article 12.”