印度化妆品注册服务

Cosmetics Registration Service Plan

一、化妆品注册介绍 Introduction:

在印度，化妆品注册过程需要对成分和标签进行细致的规划和审查。任何想进口和销售化妆品的公司都要经过这个繁琐的过程。化妆品应用程序应明确定义产品在各自的类别 

The cosmetic registration process requires meticulous planning and review of the ingredients and labeling for registration in India. Any company intending to import and market cosmetic products has to go through this tedious process. The cosmetic application should clearly define the products in respective categories.

1945 年《药品与药妆规则》DRUG & COSMECTIC RULE 1945：

根据 1945 年《药品和化妆品条例》第 21 条的规定，所有进口到印度销售的化妆 品都必须向许可机构登记。

As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, all cosmetic products imported for sale in India need to be registered with licensing authority.

进口化妆品的登记申请可由以下途径提出：

The application for Registration of Import of Cosmetics can be made by-

1:制造商自己在印度注册了办事处 

The Manufacturer himself having registered office in India

2:制造商的授权代理商 The Authorized Agent of the Manufacturer；

3:制造商的子公司 The Subsidiary of the Manufacturer；

4:任何其他进口商 Any other importer；

二、化妆品注册的类别 Category：

1:化妆产品注册 Cosmetic product registration

2:化妆品进出口商类注册 Registration for imports In India

3:化妆品制造商类注册 Cosmetic for manufacture

一）化妆产品注册 Cosmetic product registration:

1：化妆产品注册流程 Procedure：

1）确定您的产品是否需要注册，所有进口病在印度销售的化妆品都需要在 1945

年《药品和化妆品条例》第 21 条规定的许可机构进行注册。 Determine If Your

Product Requires Registration All cosmetic products that are imported for sale in

India need to be registered with the licensing authority as defined under Rule 21 of

Drugs & Cosmetic Rules, 1945.

2）指定一个授权的印度代理人 Appoint an Authorized Indian Agent；

印度的法规要求外国制造商在印度有一名授权代表，作为检查当局的联络人，协

助设备的批准和注册过程，以及警惕/不良事件报告。 

The regulations in India require that foreign manufacturers have a Authorized Representative in India who

will act on their behalf as the point of contact for inspection authorities, assist in device approvals and registration process and vigilance/adverse event reporting. To Learn More – Contact Us.

3）根据表格 42 提交监管档案 Submit the Regulatory Dossier under Form 42；档案必须准备好所需的文件清单，以便开始登记程序。签发登记证明书的申请须连同附表 D-III 所载的资料及承诺，一并缴交指定费用 

A dossier has to be prepared with the required list of documents to start the registration process. An application

for issue of a registration certificate will be accompanied by the specified fee along with the information and undertaking in Schedule D-III.

4）取得用于申请注册证书的表格 43Obtain Registration Certificate in Form 43 提交文件后，CDSCO 将带着第一封询问信返回给印度代理。在收到查询的答案后，CDSCO 将发出后续的查询信或授予许可。就单一制造商在一个或多个地点制造的任何数目的品牌进口而言，本署可向个别申请人发出表格 43 内的单一注册证书

After the document submission the CDSCO will get back to the Indian Agent with first query letter. Upon receiving the answers for the query the CDSCO will either issue a subsequent query letter or grant license. A single registration certificate in Form 43 may be issued to a particular pplicant in respect of import of any number of brands manufactured at one or more locations by a single manufacturer.

5）在印度市场营销 Marketing in India；只有获得注册证书和许可证，产品才能进入印度市场。被授权的印度代理商应及时向 CDSCO 报告在其他国家发生的任何变化、不良事件、召回等。

The product can enter the Indian market only when the registration certificate and licenses are issued. The Authorized Indian Agent should report any change, adverse events,recalls in other countries etc to the CDSCO as and when they happen

2：化妆品注册许可所需材料 DOCUMENTS REQUIRED:

• 申请人条的申请注册信 Covering letter by the applicant；

• 42 号表格 Form 42；

• 缴费凭证 Treasury Challan；

• 授权委托书 Power of Attorney；

• Schedule D III；

• 产品标签原件或复印件 Original or a copy of the Label；

• 销售许可证书(FSC)/营销授权书/生产许可证(如有)Free Sale Certificate

(FSC)/Marketing Authorization letter/Manufacturing License, if any；

• 产品规格和测试报告 Product specification and testing protocol；

• 获得市场授权或进口许可或注册的国家名单 List of countries where Market

Authorization or import permission or registration was granted；

• 产品包装，如有 Pack insert, if any；

3：关于化妆品产品标签的要求 Labeling Requirements:

4：进口化妆品的标签上会印有商标注册证号码和注册证持有人的姓名和地址

The label of imported cosmetic will bear the registration certificate number of the brand and name and address of the registration certificate holder.

在向许可机构提出申请后，在许可机构批准的适当申报地点进口后，可允许粘贴包含品牌注册证号码和注册证持有人姓名和地址的标签 

Stickering of labels containing the registration certificate number of the brand and the name and address of the registration certificate holder may be allowed to be carried out after import at a suitable declared place approved by the Licensing Authority on an

application made to the Licensing Authority. 

标签还应包含制造商的名称和地址，以及产品制造国的名称

 The Label should also bear the name and address of the manufacturer and name of the country where the product has been manufactured.

 如果产品不是在制造商拥有的工厂生产的，则标签上应注明实际生产厂家的名称和地址，或实际生产厂家所在国家的名称为“(国家名称)制造”

If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as “Made in (name of country)” should be there on the label

注册化妆品的进口商目前可以纳入印度的具体要求，如进口商的名称和地址、进口化妆品的进口许可证编号等，进口化妆品在印度的海关仓库或经中央药物标准控制组织(CDSCO)批准的地点，然后才投放市场 Importers of registered

Cosmetic products are currently allowed to incorporate India- specific requirements like name and address of importer, import License Number on imported Cosmetic products post landing in India at customs warehouse or place approved by the Central Drugs Standard Control Organization (CDSCO) prior to release into market.

4：周期 Timeframe:

在递交申请表格及其他相关文件后 6 个月内，便可获发注册证书

 The issue of a registration certificate will thus take place within 6 months of submission of the application form.

二）化妆品进出口注册 Registration for imports In India:

化妆品进出口注册流程 procedure for registration for imports In India

1）进口化妆品需要在印度中央药品标准管制中心(Central Drug Standards Controller)下的印度卫生和家庭福利部(Ministry of Health and Family Welfare)注册。

Imported cosmetics are to be registered with the Central Drug Standards Controller India under the Ministry of Health and Family Welfare.

2）填写并提交申请表到新德里的印度中央药品标准管制处，包括纸质版和电子版 

Fill and submit the application form to the Central Drug Standards Controller of India, New Delhi, both as a hard copy and also in the electronic form.

3）注册申请表(Form-42)和所需的文件一起提交给新德里 CDSCO 的药物管制处(I)。本申请书连同附表 D-III 所列明的费用及资料和承诺一并递交。表格 42 适用于由单一制造商在一个或多个地点生产的任何品牌。

The application for registration (Form-42) with required documents, are submitted to Drugs Controller General (I), CDSCO, New Delhi. This application is accompanied by the fee specified along with information and undertaking in Schedule D-III. A single application is made in Form

42 for any number of brands manufactured at one or more locations by a single manufacturer .

4）登记(表格 43)可于约三个月内取得，而登记的有效期为三年。获得化妆品注册的过程是繁琐和耗时的 The Registration (Form 43) may be obtained inapproximately three months, whereas the validity of the registration is for three years. The process of obtaining a Cosmetic Registration can be cumbersome and time consuming.

三）化妆品-制造商类 Cosmetic for manufacture:

根据 1940 年通过的《药品和化妆品法》，印度化妆品生产和销售需要下列许可证

The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act, 1940 –

1:基于表格 32 的许可证是为化妆品的制造/销售分发而签发的。 License on form 32 is issued for manufacture/ sale distribute of cosmetics. 

2:基于表格32-A的贷款许可证供生产/销售及分销化妆品之用。

on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics.

3:基于表格 37 的许可证，以代替《药物/化妆品制造许可证》，批准或续期进行药物/化妆品或用于制造药物/化妆品的原料的测试。

License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics.

三 、 印度批准销售药物和化妆品许可证的文件要求 

requirement of documents for the grant of cosmetic license in India for sale of drugs and cosmetics：

1:申请表格 Application forms

2:手续费 Challan of fee deposited

3:申报表 Declaration form

4:主要计划(蓝图)Key plan (Blue print)

5:地址图(蓝图)Site plan (Blue print)

6:拥有处所的根据 Basis of possession of the premises

7:房屋所有权的证明，如果出租 Proof of ownership of the premises, if rented

8:公司章程证明(核证副本)Proof of constitution of the firm (Certified copy)

9:根据 1940 年《药品和化妆品法》，经营者/合伙人/董事未被定罪的宣誓书

Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940

10:德里药房理事会注册证书的核证副本/注册药剂师的经验证书/合资格人士的资格证书

Certified copy of Registration Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and

qualification certificates

1. 生物数据的表格 Bio-data form

2. 注册药剂师/合资格人士关于全职工作的誓章，须经公证人正式证明

Affidavit of Registered Pharmacist/Competent person regarding fulltime

working with the firm duly attested by Notary

3. 注册药剂师/主管人员聘书(如已聘用)Appointment letter of Registered

Pharmacist/Competent person in charge, if employed person；

四、从业人员要求 Requirements on Practitioners:

国家政府指定的许可证颁发机构颁发化妆品生产许可证。制造商须确保在有合资格及合资格的技术人员在场的情况下进行生产，而其中最少一名人员须具备下列学历 

The licensing authority appointed by the State Government gives the license to manufacture any cosmetic products. The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least one of the staff persons should possess the following educational requirements:

1:1948 年印度药剂理事会根据《药剂法》批准的药学文凭;或

Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or

2:是根据 1948 年《药剂法》注册的;或

Is registered under the Pharmacy Act, 1948or  

3:已通过中级考试，其中一科为化学或获发牌当局认可为等同中级考试的任何其他考试。许可证颁发当局还命令根据该法令任命的检查员对整个房舍进行检查，在批准或拒绝在印度的美容许可证之前，必须在该处进行作业。一份详细的报告被提交到许可机构，然后决定是否授予化妆品许可证在印度或不。

Has passed the intermediate examination with one of the subjects as Chemistry or any other examination which is recognized by the Licensing Authority as equivalent to it.The Licensing Authority also orders an inspection by the inspectors appointed under the act, of the whole premises, where the operations are to be carried out before granting or refusing the cosmetic license in India. A detailed report is submitted to the Licensing Authority which then decides whether to grant the cosmetic license in India and or not

五、化妆品许可证的有效性 Validity of the cosmetic license:

该登记的有效期为 3 年，之后需要重新办理证书才能继续营业 

The registration would then be valid for 3 years after which a renewal of the certificate is required in

order to continue the business.

六、特别说明 Notes:

禁止对进口化妆品进行动物试验。

Ban On Animal Testing on Imported Cosmetics

在港口办事处清关货物时，制造商必须向有关港口办事处提交一份承诺书，声明该化妆品在 2014 年 11 月 12 日或之后未在动物身上进行测试。

(根据通告，文件编号 18- 12/2013-DC/part file date 03.02.2015)

At the time of clearance of the onsignment at the port office, an undertaking issued from the manufacturer stating that the cosmetic has not been tested on animals on 12.11.2014 or after the date is equired to be submitted to the concerned port office.

(as per circular, file no. 18- 12/2013-DC/part file dated 03.02.2015)

七、其他服务 Other Services

如果客户需要，我司可提供以下服务：

1. 财务税收服务 Financial tax services

2. 商标注册服务 Trademark registration services

3. 公证认证服务 Notarization and attest service

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