**Certificate of Cosmetics Good Manufacturing Practice (GMP) Form**

Transcription

1 **Certificate of Cosmetics Good Manufacturing Practice (GMP) Form** 2015 A A Certificate of Cosmetics Good Manufacturing Practice (GMP) is a formal affidavit attesting that the products being exported comply with all applicable laws and regulations including the U.S. Food Drug and Cosmetic Act ( Act ), which requires that cosmetic products not be adulterated or misbranded. The U.S. FDA has issued a Good Manufacturing Practice Guidance to assist manufacturers to develop processes and procedures to ensure that cosmetics are not adulterated. This certificate is provided on the basis of a company s warranty that it or its third party manufacturer manufactures the listed products in compliance with the GMP Guidance published by the U.S. FDA and is otherwise in compliance with all laws and regulations that pertain to its facilities and operations. Please note: This document cannot be altered in any way from the original format or language. The two tier pricing model reflects the authentication requirements of the more than 150 countries ICMAD services. All shipping charges and certification costs are included in the fee. No additional invoice or shipping charges will apply. Approximate completion time for GMP Certificates is 2-4 weeks from receipt by ICMAD. They are valid for 1 year. Please fill out the following information completely. Any missing information will delay the processing of your Certificate. Company Name Member # Manufacturer Distributor* *If you are a Distributor please include your Manufacturer s contact information and a Company Certificate (instructions on page 5). Manufacturers must be U.S. based and ICMAD members in good standing. The FDA s definition of a Manufacturer is the company actually filling the product. Please provide the country name in the spaces below for the type of certification required. Refer to Pages 3 and 4 for country listings. Apostille $195 Authority $345 Name and address of Member Company contact person to receive completed GMP Certificate: address: Mail this form with your completed application, Company Certificate and check or credit card authorization to: ICMAD, Addison Road, Suite 615, Addison, TX Please note: The application and Company Certificate must be signed by an officer of the ICMAD member manufacturer/distributor and must be notarized (see Page 2). This document will serve as your official INVOICE. If you have questions, contact Megan Marquis, , ext. 109, mmarquis@icmad.org.

2 Certificate of Cosmetic Good Manufacturing Practice (GMP) Application (Company name and address typed below will appear AS IS on the Certificate.) 1) Name and address of U.S. based ICMAD Member Manufacturer: Company Address City, State, Zip Telephone: Fax: 2) Name and address of U.S. based ICMAD Member Distributor (If Distributor is requesting GMP Certificate): Company Address City, State, Zip Telephone: Fax: 3) Please indicate which company should appear on the GMP Certificate if the Distributor is requesting. 4) Cosmetic(s) requiring GMP Certificate: (Please include exact product name, manufacturer s name, if applicable, and attach list on company letterhead if too long; also include type of cosmetic product, i.e., lotion, toner, polish, etc. for ICMAD s purposes only): 5) ICMAD Member Manufacturer/Distributor certifies that: a. It is a member in good standing with ICMAD, which include abiding by the ICMAD Code of Ethics. b. It abides by all Federal and State regulations pertaining to the manufacturing and marketing of this/these products. c. It complies with the appropriate cosmetic Good Manufacturing Practice Guidance, as published by the U.S. Food and Drug Administration. Notarized By: Corporate Executive Signature (Requester) Title and Date

3 Apostille Countries - $195 normal fee (3-4 weeks) / $370 expedited (1-2 weeks) Albania Andorra Antigua & Barbuda Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain* Barbados Belarus Belgium Belize Bosnia & Herzegovina Botswana Brunei Darussalam Bulgaria Cape Verde Colombia Cook Islands Costa Rica Croatia Cyprus Czech Republic Denmark Dominica Dominican Republic Ecuador El Salvador Estonia Fiji Finland France FYR of Macedonia Georgia *Special Notes for Apostille Countries: Germany Greece Grenada Honduras Hong Kong Hungary Iceland India Ireland Israel Italy Japan Kazakhstan Kyrgyzstan Latvia Lesotho Liberia Lichtenstein Lithuania Luxembourg Malawi Malta Marshall Islands Mauritius Mexico Monaco Mongolia Montenegro Namibia Netherlands New Zealand Niue Nicaragua Norway Oman Panama Paraguay* Peru Poland Portugal Republic of Moldova Romania Russia* Optional Translation Yes or No (Add l fee required) Saint Kitts and Nevis Saint Lucia Saint Vincent & Grenadines Samoa San Marino Sao Tome & Principe Serbia Seychelles Slovakia Slovenia South Africa South Korea Spain Suriname Swaziland Sweden Switzerland Tonga Trinidad & Tobago Turkey Ukraine United Kingdom Uruguay Uzbekistan Vanuatu Venezuela Yugoslavia Russia: translation is now optional. Please mark on the application if you would like the GMP Certificate to be translated. There is an additional fee for the translation. Spanish speaking countries may have Spanish product lists with English/Spanish translation per product. If needed, please provide the product list in this format. Bahrain & Paraguay can be authenticated as an Apostille or Authority country. Check with your foreign distributor on how to process it.

4 Authority Countries - $345 normal fee (3-4 weeks)/ $520 expedited (1-2 weeks) U.S. Arab Chamber of Commerce Stamp (Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Morocco, Palestine, Qatar, Saudi Arabia, Syria, Tunisia, and UAE) Algeria Bahrain* Bangladesh Benin Bolivia Brazil** Cambodia Canada Chile China Egypt Ethiopia Ghana Guatemala Guyana Haiti Indonesia Iraq Jamaica Jordan Kenya Kuwait Lebanon Libya Malaysia Morocco Myanmar Nepal Nigeria** Pakistan Palestine Paraguay* Philippines Qatar (Texas based members only) Saudi Arabia Singapore Sri Lanka South Sudan** Syria Taiwan Tanzania Thailand Tunisia Turkmenistan Uganda United Arab Emirates (UAE) Vietnam Yemen Check this box if you want U.S. Arab Chamber of Commerce Stamp **Special Notes for Authority Countries: Brazil: requires an electronic version of the product list as it must be copied and pasted into the body of the GMP Certificate. Please the product list as a Word or Excel document. Nigeria: additional per product fees apply South Sudan: additional fees are required Spanish speaking countries may have Spanish product lists with English/Spanish translation per product. If needed, please provide the product list in this format. Bahrain & Paraguay can be authenticated as an Apostille or Authority country. Check with your foreign distributor on how to process it.

5 (Please provide this document with your application. Must be sent on your company letterhead) Company Certificate in Support of ICMAD Issuance of a Good Manufacturing Certificate I am (list name of Company officer) and represent that I am fully authorized to act on behalf of the Company and provide this Certification. In consideration and support of ICMAD issuing a Certificate of Good Manufacturing Compliance by our Company and/or its manufacturers, I state as follows: Company confirms that, as a member in good standing of ICMAD, it complies with the ICMAD Code of Ethics and that any third party manufacturing facilities named below that manufacture the Company products listed below follow the Good Manufacturing Practice Guidance for cosmetics issued by the FDA and are otherwise in compliance with all laws and regulations that pertain to its facilities and its operations. (If this document is NOT provided by the manufacturer, please provide the list of manufacturers here. They also must be members in good standing of ICMAD.) Company further represents and warrants that neither Company nor any of its manufacturers have been cited by any regulatory body for violations of health codes, the manufacture or distribution of adulterated or misbranded products, or failure to otherwise comply with the processes and procedures established in the Good Manufacturing Guidance issued by the FDA. In Witness whereof I have signed this Certification on behalf of the Company this day of Signature Title Company

6 GMP Certificate Form of Payment Check Enclosed: #: Amount: $ OR Authorization for Credit Card Company Name: Name on Card: Address: Phone: Amount: Card Type: Amex MasterCard Visa Credit Card #: Expiration Date: Security Code: Business Credit Card: Yes No If no, please provide the address and telephone number of the credit card holder: