| ACTION PLAN/WORK PROGRAMME FOR THE | ||||||||
| HARMONIZATION OF ASEAN COSMETIC REGULATIONS | ||||||||
| (as of 09 February 2001 reflecting current status) | ||||||||
| GOAL | STRATEGY | ACTIVITIES | EXPECTED OUPUT | TIME FRAME | TWG CHARGE/ | STATUS OF IMPLEMENTATION | ||
| POSSIBLE DIALOGUE PARTNER | ||||||||
| 1 | Technical information on existing cosmetic regulations made available to member countries. | 1.1 | Creation of forum and venue for exchange of information. | Creation of ACCSQ Ad Hoc Working Group (AHWG) on Harmonization of Cosmetic Regulations = Product Working Group on Cosmetics (PWGC) | Terms Of Reference | Mar. 1998 | ACCSQ | Done. Mar 98 |
| 1.2 | Adoption of Principles to guide exchange of information and other goals | First PWG Meeting to Create and Adopt ASEAN Harmonization Principles | Harmonization Principles | Jul. 1998 | CPWG | Done. July 98 | ||
| Approval of Harmonization Principles | Aug. 1998 | ACCSQ | Done. Aug 98 | |||||
| Endorsement of Harmonization Principles | Sept. 1998 | SEOM | Done. Sep 98 | |||||
| 1.3 | Development of authoritative document comparing ASEAN regulations and harmonized regulatory schemes in the world. | Conduct of Comparative Study of ASEAN regulations and identify infrastructure needs of the ASEAN countries to facilitate harmonization. | Comparative Study and list of infrastructure needs | Oct. 1998 | CPWG with esperts on regulations and harmonization Thailand/Vietnam | Done. Jan 99 | ||
| 2. | ASEAN Harmonized Cosmetic Regulatory Scheme developed. | 2.1 | Development of basic framework and design. | Design harmonization schemes | ASEAN Harmonized Cosmetic Regulatory Scheme | Jan-99 | CPWG Philippines/Indonesia | Done. Jan 99 |
| CPWG meeting to review/approve proposed Harmonization Scheme | Mar-99 | CPWG | Done. March 1999 | |||||
| 2.2 | Agreement on coverage of scheme. | Approval of Final Harmonization Scheme Coverage | Mar. 1999 | ACCSQ | Done.May 1999 | |||
| Drafting of proposed Harmonization Scheme documents | 16 March - 1 May 1999 | CPWG Philippines/Indonesia | Done. May 1999 | |||||
| 2.3 | Consultation of member countries | Circulation of the draft ; ASEAN members to comment on the draft; Consult respective capitals concerned | 1 May - 21 July 1999 | CPWG | Done. May 1999. | |||
| Rework of the Harmonization Scheme documents to include inputs/comments generated from the circulation | 21 July - 31 July 1999 | Done. August 1999. | ||||||
| Finalization/ Adoption of Harmonization Scheme Documents | Final ASEAN Harmonized Cosmetic Regulatory Scheme Documents Adopted by CPWG | Aug-Dec.2001 | CPWG | Ongoing. Draft in circulation for final concurrence of CPWG Members | ||||
| 2.4 | Identification and develop-ment of Technical documents. | a. Development and b. Finalization of Technical Documents : | Technical documents as Annexes to Scheme documents. | Sept 1999 - Feb 2001 | CPWG | a. Done. Sep 1999 | ||
| 1. Illustrative List by Categories of Cosmetic Products | Indonesia | b. Done. Feb 2001 | ||||||
| 2. Common Registration Requirements and Pre-Market Approval | Philippines | |||||||
| 3. Common Ingredient Listings | Thailand | |||||||
| 4. ASEAN Cosmetic GMP Guidelines | Malaysia | |||||||
| 5. Common Labeling Requirements & Claims | Malaysia | |||||||
| 6. Common Claims Guidelines | Singapore | |||||||
| 7. Import/Export License Requirements | ||||||||
| 2.5 | Approval of Technical Documents | Adoption of Technical Documents (1-5) | Feb-01 | CPWG | Done. Feb 2001 | |||
| 2.6 | Approval of ASEAN Harmonized Cosmetic Regulatory Scheme | Final presentation to ACCSQ of the Harmonized Cosmetic Regulatory Scheme together with the technical documents | Aug-Dec 2001 | CPWG | ||||
| Endorsement of the ASEAN Harmonized Cosmetic Regulatory Scheme together with the Technical Documents to SEOM for approval | Aug-Dec 2001 | SEOM | ||||||
| 2.7 | Signing of documents by Ministers/Secretaries | Signing of the ASEAN Harmonization Scheme Documents together with Technical Documents | Sep-Dec'01 or JFM'02 | Ministers /Secretaries | ||||
| 3 | Infrastructure needs are identified and programs developed to address needs. | 3.1 | Identification of infrastructure needs and programs to address needs. | Conduct Comparative Study to identify infrastructure needs of the ASEAN countries to facilitate harmonization | Comparative Study and list of infrastructure needs | Oct. 1998 | CPWG with experts on regulations and harmonization | Done. Jan 1999 |
| Thailand/Vietnam | ||||||||
| Design general program for identified infrastructure needs | General Harmonization Infrastructure Program for ASEAN | Feb-01 | Singapore | Done. Feb 2001 | ||||
| 3.2 | Develop programs for infrastructure needs. | Develop programs to address the specific technical infrastructure needs of ASEAN countries (Cosmetic GMP, Safety Evaluation/Post Marketing Surveillance, ASEAN Scientific Committee) | List of Programs and Schedule of training and workshops. | Jun - Dec 2001 | Malaysia, Singapore, Thailand | ongoing | ||
| 3.3 | Implementation of programs to address infrastructure needs | ASEAN Workshop / Training to address infrastructure needs of the ASEAN Member Countries | Malaysia | |||||
| Singapore | ||||||||
| Thailand | ||||||||
| 4 | ASEAN Harmonized Cosmetic Regulatory Scheme is implemented. | 4.1 | Implementation of Phase I | Start of Implementation of MRA (Mutual Recognition of Product Registration) | Target Jan. 2002 | BOH* | ||
| 4.2 | Develop Notification Procedure | Establish Notification Procedure (if necessary) | CPWG | |||||
| Adoption of Notification Procedure | Notification Procedure | CPWG | ||||||
| Philippines | ||||||||
| 4.3 | Approval of Notification | Approval of Notification Procedure | ACCSQ | |||||
| documents. | Philippines | |||||||
| Endorsement of Notification Procedure | SEOM | |||||||
| Philippines | ||||||||
| 5 | Implementation is monitored and results / learnings tracked. | 5.1 | Monitor Implementation of Phase I | Conduct monitoring of Phase I and determine readiness of ASEAN countries to move to Phase II. (Success criteria: ASEAN should be 80-100% ready). | Monitoring report and recommending to go to Phase II | On going after signing of MOU | CPWG ASEAN Secretariat |
|
| 5.2 | Implementation of Phase II. | Full Implementation of Phase II - The ASEAN Cosmetic Directive | Jan. 2006 | BOH | ||||
| BOH - Board of Health NSB - National Standards Body | ||||||||