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    Schedule D3 Form

    Uploaded by

    Ellen Sullivan
    This document outlines the information and undertaking required to be submitted by a manufacturer or authorized agent for a registration certificate for cosmetics in India. It requests: 1) Details of the manufacturing premises and contacts. 2) Particulars of the cosmetics to be registered, including name, category, pack sizes, manufacturing licenses held, and countries where approved. 3) Chemical information on ingredients, specifications, testing methods, and labeling. 4) An undertaking that the manufacturer will comply with all rules and requirements and inform authorities of any changes or issues.

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    Schedule D3 Form

    Uploaded by

    Ellen Sullivan
    254 views2 pages
    This document outlines the information and undertaking required to be submitted by a manufacturer or authorized agent for a registration certificate for cosmetics in India. It requests: 1) Details of the manufacturing premises and contacts. 2) Particulars of the cosmetics to be registered, including name, category, pack sizes, manufacturing licenses held, and countries where approved. 3) Chemical information on ingredients, specifications, testing methods, and labeling. 4) An undertaking that the manufacturer will comply with all rules and requirements and inform authorities of any changes or issues.

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    It is used for cosmatics import registration

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    Schedule D3 form

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    This document outlines the information and undertaking required to be submitted by a manufacturer or authorized agent for a registration certificate for cosmetics in India. It requests: 1) Details of the manufacturing premises and contacts. 2) Particulars of the cosmetics to be registered, including name, category, pack sizes, manufacturing licenses held, and countries where approved. 3) Chemical information on ingredients, specifications, testing methods, and labeling. 4) An undertaking that the manufacturer will comply with all rules and requirements and inform authorities of any changes or issues.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    254 views2 pages

    Schedule D3 Form

    Uploaded by

    Ellen Sullivan
    This document outlines the information and undertaking required to be submitted by a manufacturer or authorized agent for a registration certificate for cosmetics in India. It requests: 1) Details of the manufacturing premises and contacts. 2) Particulars of the cosmetics to be registered, including name, category, pack sizes, manufacturing licenses held, and countries where approved. 3) Chemical information on ingredients, specifications, testing methods, and labeling. 4) An undertaking that the manufacturer will comply with all rules and requirements and inform authorities of any changes or issues.

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    SCHEDULE D (III) (See rule 129 A) INFORMATION AND UNDERTAKING REQUIRED TO BE SUBMITTED BY THE MANUFACTURER OR HIS AUTHORISED IMPORTER/DISTRIBUTOR/AGENT

    WITH THE APPLICATION FORM FOR A REGISTRATION CERTIFICATE. THE FORMAT SHALL BE PROPERLY FILLED IN FOR EACH APPLICATION IN FORM 42. 1. PATICULARS PREMISES:OF THE MANUFACTURER AND MANUFACTURING

    (a) Name and address of the manufacturer and manufacturing premises to be registered along with telephone numbers, fax numbers and e-mail address. (b) Name (s) and address of the Partners/ Directors. (c) Name and address of the authorized importer/ distributor/ agent in India, responsible for the business of the manufacturer. (d) A brief profile of the manufacturers business activity, in domestic as well as global market. 2. PARTICULARS OF THE COSMETICS TO BE REGISTERED UNDER REGISTRATION CERTIFICATE:(a) Name of cosmetics along with their brands name, category, pack sizes and variants to be registered and meant for import into and use in India. (b) Particulars of the manufacturing licenses/registration/marketing authorizations (if any) under which the cosmetics are being manufactured in the country of origin along with the copy of the Regulatory Authority of that country. (c) List of countries where marketing authorization or import permission for the said cosmetic has been granted. 3. CHEMICAL INFORMATION OF COSMETICS:(a) Name(s) of ingredients in the nomenclature of standard references, along with percentages contained in the cosmetic. (b) Specification and testing method for testing of the cosmetic(s). (c) Manner of labeling as per Drug and Cosmetics Rules, 1945. (d) Package insert (if any).

    4. UNDERTAKING TO DECLARE THAT:(a) We shall comply with all the conditions imposed on the Registration Certificate for the import of cosmetics as required under the provisions of Drug and Cosmetics rules, 1945. (b) We declare that we are carrying on the manufacture of the cosmetics in this Schedule, at the premises specified above and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories. (c) We shall comply with the provisions of Part XIII of the Drug and Cosmetics Rules, 1945. (d) Every cosmetic manufactured by us for import under the Registration Certificate into India shall conform to the specifications given in the Drug and Cosmetics Rules, 1945 as amended from time to time. (e) We shall inform to the licensing authority within 30 days in the event of any change in variants or in category or in manufacturing location or in labeling or in documentation of any of the cosmetic pertaining to the certificate to be granted to us. (f) We shall from time to time report for any administrative action taken due to adverse reaction, viz market withdrawals/ regulatory restriction or cancellation of authorization and/ or not of standard quality report of any cosmetic pertaining to the Registration Certificate declared by any Regulatory Authority of any country where the cosmetic is marketed/ sold or distributed. The dispatch and marketing of the cosmetic in such cases shall be stopped and the licensing authority shall be informed immediately. (g) We shall comply with such further requirements, if any, as may be specified by the Government of India, under the Act and the Rules, made there under. (h) We shall allow the licensing authority or any person authorized by him in that behalf to take samples of the cosmetics for testing if considered necessary by the licensing authority. The information submitted above is true to the best of my/our knowledge and belief. Place: Date: Signature of the manufacturer or His authorized agent Seal/ Stamp

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