THE MINISTRY OF HEALTH | THE SOCIALIST REPUBLIC OF VIETNAM |
No. 7866/QD-BYT | Hanoi, December 28, 2018 |
DECISION
ANNOUNCEMENT OF NEW ADMINISTRATIVE PROCESURES AND AMENDMENTS TO EXISTING ADMINISTRATIVE PROCEDURES RELATED TO COSMETICS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH
THE MINISTER OF HEALTH
Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Minister of Health;
Pursuant to the Government’s Decree No. 63/2010/ND-CP dated June 08, 2010 on administrative procedure control; Government’s Decree No. 48/2013/ND-CP dated May 14, 2013 on amendments to some Articles of Decrees related to administrative procedure control and Government’s Decree No. 92/2017/ND-CP dated August 07, 2017 on amendments to some Articles of Decrees related to administrative procedure control;
At the request of the Director of the Drug Administration of Vietnam - the Ministry of Health,
HEREBY DECIDES:
Article 1. 04 new administrative procedures and amendments to 02 existing administrative procedures in the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 which are related to cosmetics under the management of the Ministry of Health are announced together with this Decision.
Article 2. This Decision comes into force from the date on which it is signed.
Article 3. The Chief of the Ministry Office, Directors of General Departments and Departments, Ministry Inspectorate, Departments of Health of provinces and central-affiliated cities and heads of relevant units are responsible for the implementation of this Decision./.
| PP. THE MINISTER |
NEW ADMINISTRATIVE PROCEDURES AND AMENDMENTS TO EXISTING ADMINISTRATIVE PROCEDURES RELATED TO COSMETICS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH
(Enclosed with the Decision No. 7866/QD-BYT dated December 28, 2018 of the Minister of Health)
PART I.
LIST OF ADMINISTRATIVE PROCEDURES
A. List of new administrative procedures under the management of the Ministry of Health:
No. | Name of administrative procedure | Field | Authority in charge | |||
A1. Administrative procedures of central authorities | A1. Administrative procedures of central authorities | A1. Administrative procedures of central authorities | A1. Administrative procedures of central authorities | |||
1 | Issuance of receipt number of the notification of cosmetic product | Cosmetics | Drug Administration of Vietnam |
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2 | Issuance of Cosmetics Good Manufacturing Practice (CGMP-ASEAN) Certificate (hereinafter referred to as "the ASEAN CGMP Certificate") | Cosmetics | Drug Administration of Vietnam |
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3 | Approval for order for purchase of imported cosmetics for research and testing purposes | Cosmetics | Drug Administration of Vietnam |
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A2. Administrative procedures of provincial authorities | A2. Administrative procedures of provincial authorities | A2. Administrative procedures of provincial authorities | A2. Administrative procedures of provincial authorities | |||
4 | Issuance of receipt number of the notification of domestically manufactured cosmetic product | Cosmetics | Department of Health |
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B. List of amendments to existing administrative procedures under the management of the Ministry of Health:
No. | Administrative procedure documentation number | Name of existing administrative procedure | Name of legislative document providing for amendments | Field | Authority in charge | |||||
B1. Administrative procedures of provincial authorities | B1. Administrative procedures of provincial authorities | B1. Administrative procedures of provincial authorities | B1. Administrative procedures of provincial authorities | B1. Administrative procedures of provincial authorities | B1. Administrative procedures of provincial authorities | |||||
1 | B-BYT-286777-TT | Issuance of Certificates of eligibility for cosmetic manufacturing | Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as the “Decree No. 155/2018/ND-CP”) | Cosmetics | Department of Health |
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2 | B-BYT-286778-TT | Re-issuance of Certificates of eligibility for cosmetic manufacturing | Decree No. 155/2018/ND-CP | Cosmetics | Department of Health |
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PART II.
SPECIFIC CONTENTS OF EACH ADMINISTRATIVE PROCEDURE RELATED TO COSMETICS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH
A. List of new administrative procedures
A1. Administrative procedures of central authorities:
1. Procedure | Issuance of receipt number of the notification of cosmetic product | |
Sequence | Sequence | |
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Step 1: Before import,theorganization or individual responsible for placing the cosmetic product in the market shall submit an application for registration of the cosmetic product declaration to the Drug Administration of Vietnam National through the National Single-window Information Portal (at http://vnsw.gov.vn). Step 2: Within 01 working day from the receipt of the application, the Drug Administration of Vietnam shall examine it and issue a fee notice if the application is satisfactory. If the application is not satisfactory, issue a notice and specify necessary additional documents therein. Step 3: The application for registration of the cosmetic product declaration shall be processed as follows: a) Within 03 working days from the receipt of the satisfactory application and application fees, the Drug Administration of Vietnam shall issue the receipt number of the notification of cosmetic product. b) If the application is not satisfactory, within 05 working days from the receipt of the application, the Drug Administration of Vietnam shall issue an electronic notice and specify necessary additional documents therein. Additional documents include: - A written representation of amendments made by the applicant; - A notification of cosmetic product and/or other documents to which amendments are made; Within 05 working days from the receipt of the additional documents, the Drug Administration of Vietnam shall issue the receipt number of the notification of cosmetic product. If the additional documents are not satisfactory, within 05 working days from the receipt of the additional documents, the Drug Administration of Vietnam shall issue an electronic notice of failure to issue the receipt number of the notification of cosmetic product. c) Within 03 months from the date on which the abovementioned electronic notice is issued, if the Drug Administration of Vietnam does not receive any additional document, the application for registration of the cosmetic product declaration will be invalidated. In this case, the applicant that wishes to apply for registration of the cosmetic product declaration shall submit a new application and pay fees/charges as prescribed. |
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| Instructions1 | |
| Submit an application through the National Single-window Information Portal (at http://vnsw.gov.vn). |
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Composition of application and number of documents therein | Composition of application and number of documents therein | |
| - A notification of cosmetic product; - An authorization letter by the manufacturer or product owner that authorizes the organization or individual responsible for placing the cosmetic product in the market to distribute cosmetic products in Vietnam; - A Certificate of Free Sale (CFS). b. Number of documents: 01 set. |
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Time limit for processing application | Time limit for processing application | |
| - Within 03 working days from the receipt of the satisfactory application and application fees (if the receipt number has been issued); - Within 05 working days from the receipt of the application and application fees (if the receipt number has not yet been issued). |
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Entity following administrative procedures | Entity following administrative procedures | |
| An organization or individual |
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Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | |
| Drug Administration of Vietnam. |
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Result of handling of administrative procedures | Result of handling of administrative procedures | |
| Receipt number of the notification of cosmetic product. |
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Fees (if any) | Fees (if any) | |
| VND 500,000 (five hundred thousand dong). |
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Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | |
| Appendix I: Form of the notification of cosmetic product (Appendix No. 01-MP). |
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Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | |
| - The organization or individual responsible for placing the cosmetic product in the market must be licensed to trade in cosmetics in Vietnam. - Safety assessment of the cosmetic product shall be made according to ASEAN Guidelines for the Safety Assessment of a Cosmetic Product. |
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Legal bases | Legal bases | |
| - Decree No. 155/2018/ND-CP; - Decision No. 2659/QD-BYT dated June 17, 2016 of the Minister of Health; - Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of Finance; - Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health. |
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APPENDIX I
TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT
Appendix No. 01-MP
| PHẦN DÀNH CHO CƠ QUAN QUẢN LÝ (FOR OFFICIAL USE) Ngày cấp (Date acknowledged): Số công bố (Product Notification No.): Phiếu công bố có giá trị 05 năm kể từ ngày cấp. (This notification is valid for 05 years from the date of issue).
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PHIẾU CÔNG BỐ SẢN PHẨM MỸ PHẨM
TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT
þ Đánh dấu vào ô thích hợp (Tick where applicable)
THÔNG TIN SẢN PHẨM
PARTICULARS OF PRODUCT
1. Tên nhãn hàng và tên sản phẩm (Name of brand & product):
1.1. Nhãn hàng (Brand)
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1.2. Tên sản phẩm (Product Name)
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1.3. Danh sách các dạng hoặc màu (List of Variants or Shade). Tên (Names)
_______________________________________________________________________
_______________________________________________
2. Dạng sản phẩm (Product type(s))
□ Kem, nhũ tương, sữa, gel hoặc dầu dùng trên da (tay, mặt, chân, ….)
Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc)
□ Mặt nạ (chỉ trừ sản phẩm làm bong da nguồn gốc hoá học)
Face masks (with the exception of chemical peeling products)
□ Chất phủ màu (lỏng, nhão, bột)
Tinted bases (liquids, pastes, powders)
□ Phấn trang điểm, phấn dùng sau khi tắm, bột vệ sinh,…
Make-up powders, after-bath powder, hygienic powders, etc.
□ Xà phòng tắm, xà phòng khử mùi,…
Toilet soaps, deodorant soaps, etc
□ Nước hoa, nước thơm dùng vệ sinh,….
Perfumes, toilet waters and eau de Cologne
□ Sản phẩm dùng để tắm hoặc gội (muối, xà phòng, dầu, gel,…)
Bath or shower preparations (salts, foams, oils. gels, etc)
□ Sản phẩm tẩy lông
Depilatories
□ Chất khử mùi và chống mùi.
Deodorants and anti-perspirants
□ Các sản phẩm chăm sóc tóc
Hair care products
- Nhuộm và tẩy tóc
Hair tints and bleaches
- Thuốc uốn tóc, duỗi tóc, giữ nếp tóc
Products for waving, straightening and fixing
- Các sản phẩm định dạng tóc
Setting products
- Các sản phẩm làm sạch (sữa, bột, dầu gội)
Cleansing products (lotions, powders, shampoos)
- Sản phẩm cung cấp chất dinh dưỡng cho tóc (sữa, kem, dầu)
Conditioning products (lotions, creams, oils)
- Các sản phẩm tạo kiểu tóc (sữa, keo xịt tóc, sáp)
Hairdressing products (lotions, lacquers, brilliantines)
□ Sản phẩm dùng cạo râu (kem, xà phòng, sữa,...)
Shaving product (creams, foams, lotions, etc)
□ Các sản phẩm trang điểm và tẩy trang dùng cho mặt và mắt
Products for making-up and removing make-up from the face and the eyes
□ Các sản phẩm dùng cho môi
Products intended for application to the lips
□ Các sản phẩm để chăm sóc răng và miệng
Products for care of the teeth and the mouth
□ Các sản phẩm dùng để chăm sóc và tô điểm cho móng tay, móng chân
Products for nail care and make-up
□ Các sản phẩm dùng để vệ sinh bên ngoài
Products for external intimate hygiene
□ Các sản phẩm chống nắng
Sunbathing products
□ Sản phẩm làm sạm da mà không cần tắm nắng
Products for tanning without sun
□ Sản phẩm làm trắng da
Skin whitening products
□ Sản phẩm chống nhăn da
Anti-wrinkle products
□ Sản phẩm khác (đề nghị ghi rõ)
Others (please specify)
3. Mục đích sử dụng (Intended use)
________________________________________________________________________
________________________________________________________________________
4. Dạng trình bày (Product presentation(s))
□ Dạng đơn lẻ (Single product)
□ Một nhóm các màu (Arange of colours)
□ Bảng các màu trong một dạng sản phẩm (Palette(s) in a range of one product type)
□ Các sản phẩm phối hợp trong một bộ sản phẩm (Combination products in a single kit)
□ Các dạng khác (đề nghị ghi rõ). Others (please specify)
THÔNG TIN VỀ NHÀ SẢN XUẤT/ ĐÓNG GÓI
(Đề nghị đính kèm danh sách riêng nếu như có nhiều hơn một công ty sản xuất/ đóng gói để tạo ra một sản phẩm hoàn chỉnh)
PARTICULARS OF MANUFACTURER(S)/ASSEMBLER(S)
(Please attach in a separate sheet if there are more than one manufacturer/assembler)
5. Tên nhà sản xuất (Name of manufacturer):
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Địa chỉ nhà sản xuất (Nước sản xuất) (Address of manufacturer (state country):
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C | o | u | n | t | r | y |
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6. Tên công ty đóng gói (Đề nghị đánh dấu vào mục thích hợp. Có thể đánh dấu nhiều hơn 1 ô (Name of assembler (Please tick accordingly. May tick more than one box)):
□ Đóng gói chính Primary assembler | □ Đóng gói thứ cấp Secondary assembler |
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Địa chỉ của công ty đóng gói (Address of assembler (state country)):
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C | o | u | n | t | r | y |
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THÔNG TIN VỀ TỔ CHỨC, CÁ NHÂN CHỊU TRÁCH NHIỆM ĐƯA SẢN PHẨM MỸ PHẨM RA THỊ TRƯỜNG
PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET
7. Tên công ty (Name of company):
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Địa chỉ công ty (Address of company):
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Số giấy phép kinh doanh/Số giấy phép hoạt động
Business Registration Number/License to Operate Number
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THÔNG TIN VỀ NGƯỜI ĐẠI DIỆN THEO PHÁP LUẬT CỦA CÔNG TY
PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY
8. Họ và tên (Name of person):
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Chức vụ ở công ty (Designation in the company):
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THÔNG TIN VỀ CÔNG TY NHẬP KHẨU
PARTICULARS OF IMPORTER
9. Tên công ty nhập khẩu/ Name of Importer:
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Địa chỉ công ty nhập khẩu/ Address of importer:
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DANH SÁCH THÀNH PHẦN
PRODUCT INGREDIENT LIST
10. Đề nghị kiểm tra ô sau đây (Please check the following boxes):
□ Tôi đã kiểm tra bản sửa đổi từ Phụ lục II đến Phụ lục VII của danh mục các thành phần mỹ phẩm ASEAN như được công bố trên bản sửa đổi gần đây nhất của Hiệp định mỹ phẩm ASEAN. Tôi xin xác nhận rằng sản phẩm được đề cập đến trong bản công bố này không chứa bất cứ một thành phần bị cấm nào và cũng tuân thủ với danh mục hạn chế và các điều kiện quy định trong các phụ lục.
I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product in this notification does not contain any prohibited substances and is in compliance with the restrictions and conditions stipulated in the Annexes.
□ Tôi đảm nhận trách nhiệm trả lời và hợp tác toàn diện với cơ quan có thẩm quyền về bất kỳ hoạt động kiểm soát sau khi bán hàng khi có yêu cầu bởi cơ quan có thẩm quyền.
I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing activity initiated by the authority.
Danh sách thành phần đầy đủ (product full ingredient list)
(Yêu cầu ghi đầy đủ danh sách tất cả các thành phần và tỉ lệ % của những chất có giới hạn về nồng độ, hàm lượng sử dụng trong mỹ phẩm - To submit ingredient list with percentages of restricted ingredients)
No | Tên đầy đủ thành phần (tên danh pháp quốc tế hoặc sử dụng tên khoa học chuẩn đã được công nhận) Full Ingredient name (use INCI or approved nomenclature in standard references) | Tỉ lệ % của những chất có giới hạn về nồng độ, hàm lượng |
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CAM KẾT (DECLARATION)
1. Thay mặt cho công ty, tôi xin cam kết sản phẩm được đề cập trong Phiếu công bố này đạt được tất cả các yêu cầu của Hiệp định mỹ phẩm ASEAN và các phụ lục của nó.
I hereby declare on behalf of my company that the product in the notification meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices.
2. Tôi xin chịu trách nhiệm tuân thủ các điều khoản sau đây (I undertake to abide by the following conditions):
i. Đảm bảo có sẵn để cung cấp các thông tin kỹ thuật và tính an toàn khi cơ quan có thẩm quyền yêu cầu và có đầy đủ hồ sơ về các sản phẩm đã được phân phối để báo cáo trong trường hợp sản phẩm phải thu hồi.
Ensure that the product’s technical and safety information is made readily available to the regulatory authority concerned (“the Authority”) and to keep records of the distribution of the products for product recall purposes;
ii. Phải thông báo ngay cho cơ quan có thẩm quyền về các tác dụng phụ nghiêm trọng gây chết người hoặc đe doạ tính mạng của sản phẩm bằng điện thoại, fax, thư điện tử hoặc văn bản trước 7 ngày kể từ ngày biết thông tin.
iii. Phải hoàn thành báo cáo tác dụng phụ của sản phẩm (theo mẫu quy định) trong vòng 8 ngày làm việc kể từ ngày thông báo cho cơ quan có thẩm quyền về những tác dụng phụ nghiêm trọng như đã nêu trong mục 2 ii nói trên và cung cấp bất cứ thông tin nào theo yêu cầu của cơ quan có thẩm quyền.
iv. Thông báo ngay cho cơ quan có thẩm quyền về các phản ứng phụ nghiêm trọng nhưng không gây chết người hoặc đe doạ đến tính mạng của sản phẩm và trong bất cứ trường hợp nào, việc báo cáo (sử dụng mẫu báo cáo) về tác dụng phụ phải được tiến hành trước 15 ngày kể từ ngày biết về tác dụng phụ này.
Report to the Authority of all other serious adverse events that are not fatal or life threatening as soon as possible, and in any case, no later than 15 calendar days after first knowledge, using the Adverse Cosmetic Event Report Form;
v. Công bố với cơ quan có thẩm quyền khi có bất cứ sự thay đổi nào trong bản công bố này.
Notify the Authority of any change in the particulars submitted in this notification;
3. Tôi xin cam đoan rằng những thông tin được đưa ra trong bản công bố này là đúng sự thật. Tất cả các tài liệu, các thông tin liên quan đến nội dung công bố sẽ được cung cấp và các tài liệu đính kèm là bản hợp pháp hoặc sao y bản chính.
I declare that the particulars given in this notification are true, all data, and information of relevance in relation to the notification have been supplied and that the documents enclosed are authentic or true copies.
4. Tôi hiểu rằng tôi sẽ có trách nhiệm để đảm bảo tất cả các lô sản phẩm của chúng tôi đều đáp ứng các yêu cầu pháp luật, và tuân thủ tất cả tiêu chuẩn và chỉ tiêu sản phẩm đã được công bố với cơ quan có thẩm quyền.
I understand that I shall be responsible for ensuring that each consignment of my product continues to meet all the legal requirements, and conforms to all the standards and specifications of the product that I have declared to the Authority.
5. Tôi hiểu rằng trong trường hợp có tranh chấp pháp luật, tôi không được quyền sử dụng bản công bố sản phẩm mỹ phẩm đã được cơ quan có thẩm quyền chấp nhận nếu sản phẩm của chúng tôi không đạt được các yêu cầu về tiêu chuẩn, chỉ tiêu mà chúng tôi đã công bố.
I understand that I cannot place reliance on the acceptance of my product notification by the authority in any legal proceedings concerning my product, in the event that my product has failed to conform to any of the standards or specifications that I had previously declared to the Authority.
__________________________________________________________
Tên và chữ ký của người đại diện theo pháp luật của công ty
[Name and Signature of person representing the local company]
________________ Dấu của công ty [Company stamp] | _______________ Ngày [Date] |
2. Procedure | Issuance of Cosmetics Good Manufacturing Practice (CGMP-ASEAN) Certificate | |
Sequence | Sequence | |
| Step 1: The cosmetics manufacturer that wishes to apply for the ASEAN CGMP Certificate shall submit an application to the Drug Administration of Vietnam. Step 2: Within 01 working day from the receipt of the application, the Drug Administration of Vietnam shall examine it, append seals and issue an application number. The applicant shall pay fees for appraising standards and conditions for cosmetic manufacturing in accordance with applicable regulations. Step 3: The Drug Administration of Vietnam - The Ministry of Health shall consider the application, make a plan, issue a decision on inspectorate establishment, and notify the applicant at least 10 days prior to the inspection. Step 4: Carry out an inspection and process inspection results: - Carry out the inspection: + Composition of an inspectorate shall be decided by the Drug Administration of Vietnam. + The inspectorate shall inspect entire operation of the cosmetic manufacturer according to ASEAN CGMP standards and applicable specialized regulations. + The inspection record shall be made into 03 copies, 01 is kept by the applicant and 02 are kept by the Drug Administration of Vietnam. The record shall be signed by the applicant’s representative and chief of the inspectorate. The record shall specify deficiencies, propositions and proposed corrective actions upon the application of ASEAN CGMP (if any). If the applicant does not agree with comments of the inspectorate, the record shall specify all recorded comments of the applicant. - Process inspection results: + If the applicant complies with ASEAN CGMP, the Drug Administration of Vietnam shall issue the ASEAN CGMP Certificate. The certificate is valid for 03 years from the date on which it is signed. + If the applicant basically complies with ASEAN CGMP and some deficiencies have found but do not affect cosmetic quality and can be corrected for a short period of time, the inspectorate will request it to send a deficiency correction report. Within 02 months from the inspection, the applicant shall take corrective actions and submit a deficiency correction report to the Drug Administration of Vietnam. The inspectorate shall submit request the Director to consider issuing the ASEAN CGMP Certificate to the applicant. + If the applicant fails to comply with ASEAN CGMP, it shall correct deficiencies. After self-inspection of ASEAN CGMP compliance, the applicant shall submit an application for registration of inspection as if it applies for registration of inspection for the first time and enclose a deficiency correction report therewith. |
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Instructions | Instructions | |
| The application may be submitted by post or in person to the Drug Administration of Vietnam. |
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Composition of application and number of documents therein | Composition of application and number of documents therein | |
| a. Composition1: - An application form; - A copy of the business registration certificate or investment license; - An organizational chart of the applicant; - Floor plans and design drawings of the factory (including layout drawing, a map showing workers’ pathway, flow charts of ingredients, packages, semi-finished products, and finished products; water treatment system diagram); - A list of existing equipment in the factory; - A record on self-inspection of ASEAN CGMP compliance. b. Number of documents: 01 set. |
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Time limit for processing application | Time limit for processing application | |
| Not specified. |
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Entities following administrative procedures | Entities following administrative procedures | |
| An organization (the cosmetic manufacturer that wishes to apply for registration of ASEAN CGMP inspection). |
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Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | |
| Drug Administration of Vietnam. |
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Result of handling of administrative procedures | Result of handling of administrative procedures | |
| ASEAN CGMP Certificate. |
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Fees (if any) | Fees (if any) | |
| VND 20,000,000 (Twenty million dong). |
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Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | |
| Appendix I: Template for application form for registration of ASEAN CGMP inspection (Appendix No. 13-MP). |
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Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | |
| - The cosmetic manufacturer shall be legally established (an enterprise ID number is required); - The cosmetic manufacturer shall comply with ASEAN CGMP standards or equivalent acknowledged by the ASEAN Cosmetic Committee. |
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Legal bases | Legal bases | |
| - Decree No. 155/2018/ND-CP; - Decision No. 24/2006/QD-BYT dated August 14, 2006 of the Minister of Health; - Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of Finance; - Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health. |
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APPENDIX I
TEMPLATE FOR APPLICATION FORM FOR REGISTRATION OF ASEAN CGMP INSPECTION
Appendix No. 13-MP
NAME OF THE APPLICANT | THE SOCIALIST REPUBLIC OF VIETNAM |
| ... , date (dd/mm/yyyy) …. |
APPLICATION FORM FOR REGISTRATION OF ASEAN CGMP INSPECTION
To: Drug Administration of Vietnam - Ministry of Health
138A Giang Vo Street, Ba Dinh District, Hanoi
1- Name of the applicant:
2- Address:
3- Telephone: Fax: E-Mail:
Implementing the Circular No. 06/2011/TT-BYT dated January 01, 2015 of the Ministry of Health on cosmetic management and after conducting self-inspection and self-assessment of compliance with ASEAN CGMP, we would like to apply for registration of ASEAN CGMP inspection by the Drug Administration of Vietnam.
The following relevant documents are enclosed with this application form:1
1. An organizational chart.
2. Floor plans and design drawings of the factory, including layout drawing; a map showing workers’ pathway; flow charts of ingredients, packages, semi-finished products, and finished products; diagram of water supply system serving manufacturing; water treatment system diagram);
3. A list of existing equipment.
4. A record on self-inspection of ASEAN CGMP compliance.
| DIRECTOR OF COSMETIC MANUFACTURER |
1 03 documents have been removed from the application: Copy of the business registration certificate or investment license; ASEAN CGMP training and training assessment program; List of products that are being manufactured or expected to be manufactured, according to Point b Clause 2 Article 12 of the Decree No. 155/2018/ND-CP.
3. Procedure | Approval for order for purchase of imported cosmetics for research and testing purposes | |
Sequence | Sequence | |
| Step 1: The unit that wishes to import domestics for research and testing purposes shall submit an application for approval for order for purchase of imported cosmetics for research and testing purposes to the Drug Administration of Vietnam. Step 2: Within 01 working day from the receipt of the application, the Drug Administration of Vietnam shall examine it, append seals and issue an application number. Step 3. Process the order for purchase of imported cosmetics for research and testing purposes: - After obtaining approval, 02 copies are kept by the Drug Administration of Vietnam and 01 is kept by the applicant. The copy kept by the applicant shall bear a seal that reads “Copy sent to the applicant” so that it is presented to the customs authority upon following customs clearance procedures. - If the application is rejected, the Drug Administration of Vietnam shall respond to the applicant and provide explanation in writing. |
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Instructions | Instructions | |
| The application may be submitted by post or in person to the Drug Administration of Vietnam. |
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Composition of application and number of documents therein | Composition of application and number of documents therein | |
| a. Composition: An order for purchase of imported cosmetics for research and testing purposes. b. Number of documents: 03 sets. |
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Time limit for processing application | Time limit for processing application | |
| Not specified. |
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Entities following administrative procedures | Entities following administrative procedures | |
| An organization |
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Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | |
| Drug Administration of Vietnam. |
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Result of handling of administrative procedures | Result of handling of administrative procedures | |
| Order for purchase of imported cosmetics for research and testing purposes. |
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Fees (if any) | Fees (if any) | |
| Not specified. |
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Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | |
| Appendix I: Template for the order for purchase of imported cosmetics for research and testing purposes (Appendix No. 14-MP). |
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Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | |
| - The applicant is legally established (an enterprise ID number is required); - The maximum number of sample of each product is 10. |
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Legal bases | Legal bases | |
| - Decree No. 155/2018/ND-CP; - Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health. |
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APPENDIX I
TEMPLATE FOR ORDER FOR PURCHASE OF IMPORTED COSMETICS FOR RESEARCH AND TESTING PURPOSES
Appendix No. 14-MP
NAME OF THE APPLICANT | THE SOCIALIST REPUBLIC OF VIETNAM |
No. … |
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ORDER FOR PURCHASE OF IMPORTED COSMETICS FOR RESEARCH AND TESTING PURPOSES
To: Drug Administration of Vietnam - Ministry of Health
138A Giang Vo Street, Ba Dinh District, Hanoi
(Name of the applicant) has the honour to request the Drug Administration of Vietnam to consider approving the order so that the following cosmetics used for quality testing purposes are received:
No. | Name of cosmetics, dosage form and packaging specification | Product type | Ingredient | Unit | Quantity | Name of manufacturer, country | Notes |
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Drug Administration of Vietnam hereby approves the order including … page(s) … Clause (s) enclosed with the Official Dispatch No. …/QLD-MP dated … (dated) … (month), … of the Drug Administration of Vietnam. Hanoi, date (dd/mm/yyyy) …. | (Place name), date (dd/mm/yyyy) …. |
A2. Administrative procedures of provincial authorities:
4. Procedure | Issuance of receipt number of the notification of domestically manufactured cosmetic product | |
Sequence | Sequence | |
| Step 1: Before manufacturing, the organization/individual responsible for placing the cosmetic product in the market shall submit an application for registration of the cosmetic product declaration to the Department of Health of the area where the cosmetic manufacturer’s factory is located (the cosmetic products that are manufactured and packaged from imported semi-finished products are treated as domestically manufactured cosmetic products). Step 2: Within 01 working day from the receipt of the application, the Department of Health shall examine it and issue a fee notice if the application is satisfactory. Step 3: The application for registration of the cosmetic product declaration shall be processed as follows: a) Within 03 working days from the receipt of the satisfactory application and application fees, the Department of Health shall issue the receipt number of the notification of cosmetic product. b) If the application is not satisfactory, within 05 working days from the receipt of the application, the Department of Health shall issue an electronic notice and specify necessary additional documents therein. Additional documents include: - A written representation of amendments made by the applicant; - A notification of cosmetic product and/or other documents to which amendments are made; Within 05 working days from the receipt of the additional documents, the Department of Health shall issue the receipt number of the notification of cosmetic product. If the additional documents are not satisfactory, within 05 working days from the receipt of the additional documents, the Department of Health shall issue an electronic notice of failure to issue the receipt number of the notification of cosmetic product. c) Within 03 months from the date on which the abovementioned electronic notice is issued, if the Department of Health does not receive any additional document, the application for registration of the cosmetic product declaration will be invalidated. In this case, the applicant that wishes to apply for registration of the cosmetic product declaration shall submit a new application and pay fees/charges as prescribed. |
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| Instructions1 | |
| The application may be submitted by post or in person to the Department of Health. |
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Composition of application and number of documents therein | Composition of application and number of documents therein | |
| a. Composition:1 - A notification of cosmetic product; - An authorization letter by the manufacturer or product owner that authorizes the organization/individual responsible for placing the cosmetic product in the market to distribute cosmetic products in Vietnam (applicable to domestically manufactured cosmetic product that is not manufactured by the organization/individual responsible for placing the cosmetic product in the market). b. Number of documents: 01 set. |
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Time limit for processing application | Time limit for processing application | |
| - Within 03 working days from the receipt of the satisfactory application and application fees (if the receipt number has been issued); - Within 05 working days from the receipt of the application and application fees (if the receipt number has not yet been issued). |
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Entities following administrative procedures | Entities following administrative procedures | |
| An organization or individual |
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Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | |
| Department of Health. |
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Result of handling of administrative procedures | Result of handling of administrative procedures | |
| Receipt number of the notification of cosmetic product. |
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Fees (if any) | Fees (if any) | |
| VND 500,000 (five hundred thousand dong). |
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Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | |
| Appendix I: Template for notification of cosmetic product (Appendix No. 01-MP). |
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Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | |
| - The organization or individual responsible for placing the cosmetic product in the market must be licensed to trade in cosmetics in Vietnam. - Safety assessment of the cosmetic product shall be made according to ASEAN Guidelines for the Safety Assessment of a Cosmetic Product. - The cosmetic manufacturer shall obtain the certificate of eligibility for cosmetic manufacturing issued by the Department of Health of the area where its factory is located. |
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Legal bases | Legal bases | |
| - Decree No. 155/2018/ND-CP; - Government’s Decree No. 93/2016/ND-CP dated July 01, 2016; - Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of Finance; - Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health. |
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1 01 document has been removed from the application: the business registration certificate of the organization or individual responsible for placing the cosmetic product in the market, according to Point a Clause 1 Article 12 of the Decree No. 155/2018/ND-CP.
APPENDIX I
TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT
Appendix No. 01-MP
PHẦN DÀNH CHO CƠ QUAN QUẢN LÝ (FOR OFFICIAL USE) Ngày cấp (Date acknowledged): Số công bố (Product Notification No.): Phiếu công bố có giá trị 05 năm kể từ ngày cấp. (This notification is valid for 05 years from the date of issue)
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PHIẾU CÔNG BỐ SẢN PHẨM MỸ PHẨM
TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT
þ Đánh dấu vào ô thích hợp (Tick where applicable)
THÔNG TIN SẢN PHẨM
PARTICULARS OF PRODUCT
1. Tên nhãn hàng và tên sản phẩm (Name of brand & product):
1.1. Nhãn hàng (Brand)
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1.2. Tên sản phẩm (Product Name)
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1.3. Danh sách các dạng hoặc màu (List of Variants or Shade). Tên (Names)
_____________________________________________________________________________
_______________________________________________
2. Dạng sản phẩm (Product type(s))
□ Kem, nhũ tương, sữa, gel hoặc dầu dùng trên da (tay, mặt, chân, ….)
Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc)
□ Mặt nạ (chỉ trừ sản phẩm làm bong da nguồn gốc hoá học)
Face masks (with the exception of chemical peeling products)
□ Chất phủ màu (lỏng, nhão, bột)
Tinted bases (liquids, pastes, powders)
□ Các phấn trang điểm, phấn dùng sau khi tắm, bột vệ sinh,…
Make-up powders, after-bath powder, hygienic powders, etc.
□ Xà phòng tắm, xà phòng khử mùi,…
Toilet soaps, deodorant soaps, etc
□ Nước hoa, nước thơm dùng vệ sinh,….
Perfumes, toilet waters and eau de Cologne
□ Các sản phẩm dùng để tắm hoặc gội (muối, xà phòng, dầu, gel,…)
Bath or shower preparations (salts, foams, oils. gels, etc)
□ Sản phẩm tẩy lông
Depilatories
□ Chất khử mùi và chống mùi
Deodorants and anti-perspirants
□ Các sản phẩm chăm sóc tóc
Hair care products
- Nhuộm và tẩy tóc
Hair tints and bleaches
- Thuốc uốn tóc, duỗi tóc, giữ nếp tóc
Products for waving, straightening and fixing
- Các sản phẩm định dạng tóc
Setting products
- Các sản phẩm làm sạch (sữa, bột, dầu gội)
Cleansing products (lotions, powders, shampoos)
- Sản phẩm cung cấp chất dinh dưỡng cho tóc (sữa, kem, dầu)
Conditioning products (lotions, creams, oils)
- Các sản phẩm tạo kiểu tóc (sữa, keo xịt tóc, sáp)
Hairdressing products (lotions, lacquers, brilliantines)
□ Sản phẩm dùng cạo râu (kem, xà phòng, sữa,...)
Shaving product (creams, foams, lotions, etc)
□ Các sản phẩm trang điểm và tẩy trang dùng cho mặt và mắt
Products for making-up and removing make-up from the face and the eyes
□ Các sản phẩm dùng cho môi
Products intended for application to the lips
□ Các sản phẩm để chăm sóc răng và miệng
Products for care of the teeth and the mouth
□ Các sản phẩm dùng để chăm sóc và tô điểm cho móng tay, móng chân
Products for nail care and make-up
□ Các sản phẩm dùng để vệ sinh bên ngoài
Products for external intimate hygiene
□ Các sản phẩm chống nắng
Sunbathing products
□ Sản phẩm làm sạm da mà không cần tắm nắng
Products for tanning without sun
□ Sản phẩm làm trắng da
Skin whitening products
□ Sản phẩm chống nhăn da
Anti-wrinkle products
□ Sản phẩm khác (đề nghị ghi rõ)
Others (please specify)
3. Mục đích sử dụng (Intended use)
________________________________________________________________________
________________________________________________________________________
4. Dạng trình bày (Product presentation(s))
□ Dạng đơn lẻ (Single product)
□ Một nhóm các màu (Arange of colours)
□ Bảng các màu trong một dạng sản phẩm (Palette(s) in a range of one product type)
□ Các sản phẩm phối hợp trong một bộ sản phẩm (Combination products in a single kit)
□ Các dạng khác (đề nghị ghi rõ). Others (please specify)
THÔNG TIN VỀ NHÀ SẢN XUẤT/ ĐÓNG GÓI
(Đề nghị đính kèm danh sách riêng nếu như có nhiều hơn một công ty tham gia sản xuất/ đóng gói để tạo ra một sản phẩm hoàn chỉnh)
PARTICULARS OF MANUFACTURER(S)/ASSEMBLER(S)
(Please attach in a separate sheet if there are more than one manufacturer/assembler)
5. Tên nhà sản xuất (Name of manufacturer):
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Địa chỉ nhà sản xuất (Nước sản xuất) (Address of manufacturer (state country):
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C | o | u | n | t | r | y |
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6. Tên công ty đóng gói (Đề nghị đánh dấu vào mục thích hợp. Có thể đánh dấu nhiều hơn 1 ô (Name of assembler (Please tick accordingly. May tick more than one box)):
o Đóng gói chính Primary assembler | o Đóng gói thứ cấp Secondary assembler |
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Địa chỉ của công ty đóng gói (Address of assembler (state country)):
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C | o | u | n | t | r | y |
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THÔNG TIN VỀ TỔ CHỨC, CÁ NHÂN CHỊU TRÁCH NHIỆM ĐƯA SẢN PHẨM MỸ PHẨM RA THỊ TRƯỜNG
PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET
7. Tên công ty (Name of company):
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Địa chỉ công ty (Address of company):
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Số giấy phép kinh doanh/Số giấy phép hoạt động
Business Registration Number/License to Operate Number
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THÔNG TIN VỀ NGƯỜI ĐẠI DIỆN THEO PHÁP LUẬT CỦA CÔNG TY
PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY
8. Họ và tên (Name of person):
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Chức vụ ở công ty (Designation in the company):
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THÔNG TIN VỀ CÔNG TY NHẬP KHẨU
PARTICULARS OF IMPORTER
9. Tên công ty nhập khẩu/ Name of Importer:
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Địa chỉ công ty nhập khẩu/ Address of importer:
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DANH SÁCH THÀNH PHẦN
PRODUCT INGREDIENT LIST
10. Đề nghị kiểm tra ô sau đây (Please check the following boxes)
□ Tôi đã kiểm tra bản sửa đổi từ Phụ lục II đến Phụ lục VII của danh mục các thành phần mỹ phẩm ASEAN như được công bố trên bản sửa đổi gần đây nhất của Hiệp định mỹ phẩm ASEAN. Tôi xin xác nhận rằng sản phẩm được đề cập đến trong bản công bố này không chứa bất cứ một thành phần bị cấm nào và cũng tuân thủ với danh mục hạn chế và các điều kiện quy định trong các phụ lục.
I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product in this notification does not contain any prohibited substances and is in compliance with the restrictions and conditions stipulated in the Annexes.
□ Tôi đảm nhận trách nhiệm trả lời và hợp tác toàn diện với cơ quan có thẩm quyền về bất kỳ hoạt động kiểm soát sau khi bán hàng khi có yêu cầu bởi cơ quan có thẩm quyền.
I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing activity initiated by the authority.
Danh sách thành phần đầy đủ (product full ingredient list)
(Yêu cầu ghi đầy đủ danh sách tất cả các thành phần và tỉ lệ % của những chất có giới hạn về nồng độ, hàm lượng sử dụng trong mỹ phẩm - To submit ingredient list with percentages of restricted ingredients)
No | Tên đầy đủ thành phần (tên danh pháp quốc tế hoặc sử dụng tên khoa học chuẩn đã được công nhận) Full Ingredient name (use INCI or approved nomenclature in standard references) | Tỉ lệ % của những chất có giới hạn về nồng độ, hàm lượng |
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CAM KẾT (DECLARATION)
1. Thay mặt cho công ty, tôi xin cam kết sản phẩm được đề cập trong Phiếu công bố này đạt được tất cả các yêu cầu của Hiệp định mỹ phẩm ASEAN và các phụ lục của nó.
I hereby declare on behalf of my company that the product in the notification meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices.
2. Tôi xin chịu trách nhiệm tuân thủ các điều khoản sau đây (I undertake to abide by the following conditions):
i. Đảm bảo có sẵn để cung cấp các thông tin kỹ thuật và tính an toàn khi cơ quan có thẩm quyền yêu cầu và có đầy đủ hồ sơ về các sản phẩm đã được phân phối để báo cáo trong trường hợp sản phẩm phải thu hồi.
Ensure that the product’s technical and safety information is made readily available to the regulatory authority concerned (“the Authority”) and to keep records of the distribution of the products for product recall purposes;
ii. Phải thông báo ngay cho cơ quan có thẩm quyền về các tác dụng phụ nghiêm trọng gây chết người hoặc đe doạ tính mạng của sản phẩm bằng điện thoại, fax, thư điện tử hoặc văn bản trước 7 ngày kể từ ngày biết thông tin.
Notify the Authority of fatal or life threatening serious adverse event3 as soon as possible by telephone, facsimile transmission, email or in writing, and in any case, no later than 7 calendar days after first knowledge;
iii. Phải hoàn thành báo cáo tác dụng phụ của sản phẩm (theo mẫu quy định) trong vòng 8 ngày làm việc kể từ ngày thông báo cho cơ quan có thẩm quyền về những tác dụng phụ nghiêm trọng như đã nêu trong mục 2 ii nói trên và cung cấp bất cứ thông tin nào theo yêu cầu của cơ quan có thẩm quyền.
Complete the Adverse Cosmetic Event Report Form4 within 8 calendar days from the date of my notification to the Authority in para 2 ii. above, and to provide any other information as may be requested by the Authority;
iv. Thông báo ngay cho cơ quan có thẩm quyền về các phản ứng phụ nghiêm trọng nhưng không gây chết người hoặc đe dọa đến tính mạng của sản phẩm và trong bất cứ trường hợp nào, việc báo cáo (sử dụng mẫu báo cáo) về tác dụng phụ phải được tiến hành trước 15 ngày kể từ ngày biết về tác dụng phụ này.
Report to the Authority of all other serious adverse events that are not fatal or life threatening as soon as possible, and in any case, no later than 15 calendar days after first knowledge, using the Adverse Cosmetic Event Report Form;
v. Công bố với cơ quan có thẩm quyền khi có bất cứ sự thay đổi nào trong bản công bố này.
Notify the Authority of any change in the particulars submitted in this notification;
3. Tôi xin cam đoan rằng những thông tin được đưa ra trong bản công bố này là đúng sự thật. Tất cả các tài liệu, các thông tin liên quan đến nội dung công bố sẽ được cung cấp và các tài liệu đính kèm là bản hợp pháp hoặc sao y bản chính.
I declare that the particulars given in this notification are true, all data, and information of relevance in relation to the notification have been supplied and that the documents enclosed are authentic or true copies.
4. Tôi hiểu rằng tôi sẽ có trách nhiệm để đảm bảo tất cả các lô sản phẩm của chúng tôi đều đáp ứng các yêu cầu pháp luật, và tuân thủ tất cả tiêu chuẩn và chỉ tiêu sản phẩm đã được công bố với cơ quan có thẩm quyền.
I understand that I shall be responsible for ensuring that each consignment of my product continues to meet all the legal requirements, and conforms to all the standards and specifications of the product that I have declared to the Authority.
5. Tôi hiểu rằng trong trường hợp có tranh chấp pháp luật, tôi không được quyền sử dụng bản công bố sản phẩm mỹ phẩm đã được cơ quan có thẩm quyền chấp nhận nếu sản phẩm của chúng tôi không đạt được các yêu cầu về tiêu chuẩn, chỉ tiêu mà chúng tôi đã công bố.
I understand that I cannot place reliance on the acceptance of my product notification by the authority in any legal proceedings concerning my product, in the event that my product has failed to conform to any of the standards or specifications that I had previously declared to the Authority.
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Tên và chữ ký của người đại diện theo pháp luật của công ty
[Name and Signature of person representing the local company]
_______________ Dấu của công ty [Company stamp] | ______________ Ngày [Date] |
3 Như đã được định nghĩa rõ ràng trong tài liệu hướng dẫn cho các công ty về báo cáo tác dụng phụ của sản phẩm mỹ phẩm. As defined in the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products.
4 Trình bày trong phụ lục I trong tài liệu hướng dẫn cho các công ty về báo cáo tác dụng phụ của sản phẩm mỹ phẩm. Set out in Appendex I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products.
B. List of amendments to existing administrative procedures
B1. Administrative procedures of provincial authorities
1- Procedure | Issuance of Certificate of eligibility for cosmetic manufacturing | Issuance of Certificate of eligibility for cosmetic manufacturing | ||
Sequence | Sequence | Sequence | ||
| Step 1: Before manufacturing, the cosmetic manufacturer shall submit an application for issuance of the certificate of eligibility for cosmetic manufacturing to the Department of Health. Step 2: Within 02 working days from the receipt of the application, the Department of Health shall examine it and issue an application receipt notice according to the Form No. 05 in the Appendix enclosed with the Government’s Decree No. 93/2016/ND-CP if the application is satisfactory. If the application is unsatisfactory, issue a notice and specify necessary additional documents therein. Step 3: Within 30 days from the receipt of the satisfactory application and application fees, the Department of Health shall inspect the manufacturer and issue the certificate of eligibility for cosmetic manufacturing. If the application is rejected or the manufacturer is requested to take corrective actions, the Department of Health shall respond and explain in writing. - If the cosmetic manufacturer is requested to take corrective actions: + The cosmetic manufacturer shall take corrective actions and submit a correction report to the Department of Health. + The Department of Health shall consider the report, re-inspect the application or the manufacturer (if necessary) and provide inspection results in writing within 15 days from the receipt of the correction report. - If the cosmetic manufacturer is eligible to be issued with the ASEAN CGMP Certificate by the Ministry of Health: + The Ministry of Health shall send an Official Dispatch to the Department of Health of the area where the cosmetic manufacturer's factory is located with respect to the issuance of the certificate of eligibility for cosmetic manufacturing. + The Department of Health shall issue the certificate of eligibility for cosmetic manufacturing to such cosmetic manufacturer. | Step 1: Before manufacturing, the cosmetic manufacturer shall submit an application for issuance of the certificate of eligibility for cosmetic manufacturing to the Department of Health. Step 2: Within 02 working days from the receipt of the application, the Department of Health shall examine it and issue an application receipt notice according to the Form No. 05 in the Appendix enclosed with the Government’s Decree No. 93/2016/ND-CP if the application is satisfactory. If the application is unsatisfactory, issue a notice and specify necessary additional documents therein. Step 3: Within 30 days from the receipt of the satisfactory application and application fees, the Department of Health shall inspect the manufacturer and issue the certificate of eligibility for cosmetic manufacturing. If the application is rejected or the manufacturer is requested to take corrective actions, the Department of Health shall respond and explain in writing. - If the cosmetic manufacturer is requested to take corrective actions: + The cosmetic manufacturer shall take corrective actions and submit a correction report to the Department of Health. + The Department of Health shall consider the report, re-inspect the application or the manufacturer (if necessary) and provide inspection results in writing within 15 days from the receipt of the correction report. - If the cosmetic manufacturer is eligible to be issued with the ASEAN CGMP Certificate by the Ministry of Health: + The Ministry of Health shall send an Official Dispatch to the Department of Health of the area where the cosmetic manufacturer's factory is located with respect to the issuance of the certificate of eligibility for cosmetic manufacturing. + The Department of Health shall issue the certificate of eligibility for cosmetic manufacturing to such cosmetic manufacturer. |
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Instructions | Instructions | Instructions | ||
| The application may be submitted by post or in person to the Department of Health. | The application may be submitted by post or in person to the Department of Health. |
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Composition of application and number of documents therein | Composition of application and number of documents therein | Composition of application and number of documents therein | ||
| - An application form, which is made using the Form No. 02 in the Appendix enclosed with the Government’s Decree No. 93/2016/ND-CP. - Floor plans and design drawings of the manufacturer; - A list of manufacturer’s existing equipment. b. Number of documents: 01 set. | a. Composition:1 - An application form, which is made using the Form No. 02 in the Appendix enclosed with the Government’s Decree No. 93/2016/ND-CP. - Floor plans and design drawings of the manufacturer; - A list of manufacturer’s existing equipment. b. Number of documents: 01 set. |
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Time limit for processing application | Time limit for processing application | Time limit for processing application | ||
| Within 30 working days from the receipt of the satisfactory application. | Within 30 working days from the receipt of the satisfactory application. |
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Entities following administrative procedures | Entities following administrative procedures | Entities following administrative procedures | ||
| An organization (the cosmetic manufacturer). | An organization (the cosmetic manufacturer). |
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Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | ||
| Department of Health. | Department of Health. |
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Result of handling of administrative procedures | Result of handling of administrative procedures | Result of handling of administrative procedures | ||
| Certificate of eligibility for cosmetic manufacturing | Certificate of eligibility for cosmetic manufacturing |
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Fees (if any) | Fees (if any) | Fees (if any) | ||
| VND 6,000,000 (Six million dong). | VND 6,000,000 (Six million dong). |
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Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | ||
| - Appendix I: Application form for issuance of Certificate of eligibility for cosmetic manufacturing (Form No. 02); - Appendix II: Application receipt notice (Form No. 05). | - Appendix I: Application form for issuance of Certificate of eligibility for cosmetic manufacturing (Form No. 02); - Appendix II: Application receipt notice (Form No. 05). |
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Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | ||
| The cosmetic manufacturer shall satisfy the following requirements: - Personnel requirement: the production manager must have professional knowledge about one of the following disciplines: Chemistry, Biology, Pharmacy or other relevant disciplines in order to meet job requirements. - Infrastructure requirement: + Its location, area, workshop and equipment must meet requirements on the production line and types of cosmetic products which will be produced by that manufacturer as described in the application for Certificate of eligibility for cosmetic manufacturing; + Raw materials, packaging materials and finished products stores must ensure the separation between raw materials, and packaging materials, and finished products, and have separate areas for storing flammable and explosive matters, highly toxic substances, discharged, recalled and returned materials or products. + The water used in the manufacturing of cosmetic products must comply with the national technical regulation on drinking water quality promulgated by Minister of Health; + The production process must be available for each type of cosmetic products; + The quality of raw materials, semi-finished products, bulk products and finished products must be monitored by quality control divisions. | The cosmetic manufacturer shall satisfy the following requirements: - Personnel requirement: the production manager must have professional knowledge about one of the following disciplines: Chemistry, Biology, Pharmacy or other relevant disciplines in order to meet job requirements. - Infrastructure requirement: + Its location, area, workshop and equipment must meet requirements on the production line and types of cosmetic products which will be produced by that manufacturer as described in the application for Certificate of eligibility for cosmetic manufacturing; + Raw materials, packaging materials and finished products stores must ensure the separation between raw materials, and packaging materials, and finished products, and have separate areas for storing flammable and explosive matters, highly toxic substances, discharged, recalled and returned materials or products. - Its quality management system must satisfy the following requirements:2 + Raw materials, auxiliary materials and semi-finished products used to manufacture cosmetic products must meet quality standards adopted by the manufacturer;3 + The water used in the manufacturing of cosmetic products must comply with the national technical regulation on drinking water quality promulgated by Minister of Health; + The production process must be available for each type of cosmetic products; + The quality of raw materials, semi-finished products, bulk products and finished products must be monitored by quality control divisions. |
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Legal bases | Legal bases | Legal bases | ||
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| - Law on Investment 2014; - Government’s Decree No. 93/2016/ND-CP dated July 01, 2016; - Decree No. 155/2018/ND-CP; - Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of Finance. |
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APPENDIX I
TEMPLATE FOR APPLICATION FORM FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING
Form No. 02
NAME OF THE APPLICANT | THE SOCIALIST REPUBLIC OF VIETNAM |
| (Place name), date (dd/mm/yyyy) …. |
APPLICATION FORM FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING
To: ……..
Name of the applicant:
Address:
Business registration certificate number, date of issue, place of issue
Telephone: ……………………………….Fax: ……………. E-mail: …………………
Pursuant to the Government’s Decree No. …….dated ………..(month) ………(date) ……….(year) providing for conditions for cosmetic manufacturing, (name of the applicant) ... has the honour to request the Department of Health of … to issue the Certificate of eligibility for cosmetic manufacturing (our production lines consist of: ..(*)), this application includes the following documents:
1. The site plans and design drawings of the factory;
2. A list of existing equipment in the factory;
(Name of the applicant) …………hereby declare that all contents stated herein are true and authentic and bear responsibility for such contents.
| DIRECTOR OF COSMETIC MANUFACTURER |
(*) Names of production lines must be specified, consisting of: Product packaging line; production line for producing semi-finished products in dry form; production line for producing semi-finished products in wet form; production line for producing finished products in dry or wet or other form.
APPENDIX II
TEMPLATE FOR APPLICATION RECEIPT NOTICE
Form No. 05
PEOPLE’S COMMITTEE OF ……PROVINCE | THE SOCIALIST REPUBLIC OF VIETNAM |
No. /PTN- | (Place name), date (dd/mm/yyyy) …. |
APPLICATION RECEIPT NOTICE
Full name of receiver: ………………………………………………………………………………….
Position, working place: ………………………………………………………………………………
Has received the application (*)……..submitted by the cosmetic manufacturer: .........................................................
The application consists of the following documents:
1..................................................
2..................................................
3..................................................
| RECEIVER |
(*) The application for issuance, or re-issuance, or amendment of Certificate of eligibility for cosmetic manufacturing must be specified.
2-Procedure | Re-issuance of Certificate of eligibility for cosmetic manufacturing | |
Sequence | Sequence | |
| Step 1: The cosmetic manufacturer shall submit an application for re-issuance of the certificate of eligibility for cosmetic manufacturing to the Department of Health. Step 2: Within 02 working days from the receipt of the application, the Department of Health shall examine it and issue an application receipt notice according to the Form No. 05 in the Appendix enclosed with the Government’s Decree No. 93/2016/ND-CP if the application is satisfactory. If the application is unsatisfactory, issue a notice and specify necessary additional documents therein. Step 3: Within 05 working days from the receipt of the satisfactory application, the Department of Health shall re-issue the certificate of eligibility for cosmetic manufacturing. |
|
Instructions | Instructions | |
| The application may be submitted by post or in person to the Department of Health. |
|
Composition of application and number of documents therein | Composition of application and number of documents therein | |
| An application form, which is made using the Form No. 03 in the Appendix enclosed with the Government’s Decree No. 93/2016/ND-CP. b. Number of documents: 01 set. |
|
Time limit for processing application | Time limit for processing application | |
| Within 05 working days from the receipt of the satisfactory application. |
|
Entities following administrative procedures | Entities following administrative procedures | |
| An organization (the cosmetic manufacturer). |
|
Authority in charge of handling administrative procedures | Authority in charge of handling administrative procedures | |
| Department of Health. |
|
Result of handling of administrative procedures | Result of handling of administrative procedures | |
| Certificate of eligibility for cosmetic manufacturing |
|
Fees (if any) | Fees (if any) | |
| Not specified. |
|
Name of template (Enclosed with this procedure) | Name of template (Enclosed with this procedure) | |
| - Appendix I: Application form for re-issuance of the Certificate of eligibility for cosmetic manufacturing (Form No. 03); - Appendix II: An application receipt notice (Form No. 05). |
|
Conditions for following administrative procedures (if any) | Conditions for following administrative procedures (if any) | |
| Not available |
|
Legal bases | Legal bases | |
| - Law on Investment 2014; - Government’s Decree No. 93/2016/ND-CP dated July 01, 2016; - Decree No. 155/2018/ND-CP. |
|
APPENDIX I
TEMPLATE FOR APPLICATION FORM FOR RE-ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING
Form No. 03
NAME OF THE APPLICANT | THE SOCIALIST REPUBLIC OF VIETNAM |
| (Place name), date (dd/mm/yyyy) …. |
APPLICATION FORM FOR RE-ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING
To: ……..
Name of the applicant:
Address:
Business registration certificate number, date of issue, place of issue.
Telephone: …………………… Fax: ……………….E-mail: ………………………
Pursuant to the Government’s Decree No. …….dated ………..(month) ………(date) ……….(year) providing for conditions for cosmetic manufacturing, (name of the applicant) ... has the honour to request the Department of Health of … to re-issue the Certificate of eligibility for cosmetic manufacturing on the basis of the issued Certificate of eligibility for cosmetic manufacturing No. ……., issued on...........[date]
Reason for re-issuance: ………………………………………………………………….(*)
(Name of the applicant) …………hereby declare that all contents stated herein are true and authentic and bear responsibility for such contents.
| DIRECTOR OF COSMETIC MANUFACTURER |
(*) Reasons for re-issuance must be specified as: Loss or damage.
APPENDIX II
TEMPLATE FOR APPLICATION RECEIPT NOTICE
Form No. 05
PEOPLE’S COMMITTEE OF ……PROVINCE | THE SOCIALIST REPUBLIC OF VIETNAM |
No. /PTN- | (Place name), date (dd/mm/yyyy) …. |
APPLICATION RECEIPT NOTICE
Full name of receiver: ………………………………………………………………………………….
Position, working place: ………………………………………………………………………………
Has received the application (*)……..submitted by the cosmetic manufacturer: .........................................................
The application consists of the following documents:
1..................................................
2..................................................
3..................................................
| RECEIVER |
(*) The application for issuance, or re-issuance, or amendment of Certificate of eligibility for cosmetic manufacturing must be specified.
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