印度化妝品注冊服務

Cosmetics Registration Service Plan

一、化妝品注冊介紹 Introduction:

在印度，化妝品注冊過程需要對成分和標簽進行細致的規劃和審查。任何想進口和銷售化妝品的公司都要經過這個繁瑣的過程。化妝品應用程序應明確定義產品在各自的類別 

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《藥品與藥妝規則》DRUG & COSMECTIC RULE 1945：

根據 1945 年《藥品和化妝品條例》第 21 條的規定，所有進口到印度銷售的化妝 品都必須向許可機構登記。

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.

進口化妝品的登記申請可由以下途徑提出：

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

1:制造商自己在印度注冊了辦事處 

The Manufacturer himself having registered office in India

2:制造商的授權代理商 The Authorized Agent of the Manufacturer；

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

4:任何其他進口商 Any other importer；

二、化妝品注冊的類別 Category：

1:化妝產品注冊 Cosmetic product registration

2:化妝品進出口商類注冊 Registration for imports In India

3:化妝品制造商類注冊 Cosmetic for manufacture

一）化妝產品注冊 Cosmetic product registration:

1：化妝產品注冊流程 Procedure：

1）確定您的產品是否需要注冊，所有進口病在印度銷售的化妝品都需要在 1945

年《藥品和化妝品條例》第 21 條規定的許可機構進行注冊。 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）指定一個授權的印度代理人 Appoint an Authorized Indian Agent；

印度的法規要求外國制造商在印度有一名授權代表，作為檢查當局的聯絡人，協

助設備的批準和注冊過程，以及警惕/不良事件報告。 

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）根據表格 42 提交監管檔案 Submit the Regulatory Dossier under Form 42；檔案必須準備好所需的文件清單，以便開始登記程序。簽發登記證明書的申請須連同附表 D-III 所載的資料及承諾，一并繳交指定費用 

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）取得用于申請注冊證書的表格 43Obtain Registration Certificate in Form 43 提交文件后，CDSCO 將帶著第一封詢問信返回給印度代理。在收到查詢的答案后，CDSCO 將發出后續的查詢信或授予許可。就單一制造商在一個或多個地點制造的任何數目的品牌進口而言，本署可向個別申請人發出表格 43 內的單一注冊證書

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）在印度市場營銷 Marketing in India；只有獲得注冊證書和許可證，產品才能進入印度市場。被授權的印度代理商應及時向 CDSCO 報告在其他國家發生的任何變化、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：化妝品注冊許可所需材料 DOCUMENTS REQUIRED:

? 申請人條的申請注冊信 Covering letter by the applicant；

? 42 號表格 Form 42；

? 繳費憑證 Treasury Challan；

? 授權委托書 Power of Attorney；

? Schedule D III；

? 產品標簽原件或復印件 Original or a copy of the Label；

? 銷售許可證書(FSC)/營銷授權書/生產許可證(如有)Free Sale Certificate

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

? 產品規格和測試報告 Product specification and testing protocol；

? 獲得市場授權或進口許可或注冊的國家名單 List of countries where Market

Authorization or import permission or registration was granted；

? 產品包裝，如有 Pack insert, if any；

3：關于化妝品產品標簽的要求 Labeling Requirements:

4：進口化妝品的標簽上會印有商標注冊證號碼和注冊證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.

在向許可機構提出申請后，在許可機構批準的適當申報地點進口后，可允許粘貼包含品牌注冊證號碼和注冊證持有人姓名和地址的標簽 

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. 

標簽還應包含制造商的名稱和地址，以及產品制造國的名稱

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

 如果產品不是在制造商擁有的工廠生產的，則標簽上應注明實際生產廠家的名稱和地址，或實際生產廠家所在國家的名稱為“(國家名稱)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

注冊化妝品的進口商目前可以納入印度的具體要求，如進口商的名稱和地址、進口化妝品的進口許可證編號等，進口化妝品在印度的海關倉庫或經中央藥物標準控制組織(CDSCO)批準的地點，然后才投放市場 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:

在遞交申請表格及其他相關文件后 6 個月內，便可獲發注冊證書

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

二）化妝品進出口注冊 Registration for imports In India:

化妝品進出口注冊流程 procedure for registration for imports In India

1）進口化妝品需要在印度中央藥品標準管制中心(Central Drug Standards Controller)下的印度衛生和家庭福利部(Ministry of Health and Family Welfare)注冊。

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

2）填寫并提交申請表到新德里的印度中央藥品標準管制處，包括紙質版和電子版 

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）注冊申請表(Form-42)和所需的文件一起提交給新德里 CDSCO 的藥物管制處(I)。本申請書連同附表 D-III 所列明的費用及資料和承諾一并遞交。表格 42 適用于由單一制造商在一個或多個地點生產的任何品牌。

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）登記(表格 43)可于約三個月內取得，而登記的有效期為三年。獲得化妝品注冊的過程是繁瑣和耗時的 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）化妝品-制造商類 Cosmetic for manufacture:

根據 1940 年通過的《藥品和化妝品法》，印度化妝品生產和銷售需要下列許可證

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 的許可證是為化妝品的制造/銷售分發而簽發的。 License on form 32 is issued for manufacture/ sale distribute of cosmetics. 

2:基于表格32-A的貸款許可證供生產/銷售及分銷化妝品之用。

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

3:基于表格 37 的許可證，以代替《藥物/化妝品制造許可證》，批準或續期進行藥物/化妝品或用于制造藥物/化妝品的原料的測試。

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 、 印度批準銷售藥物和化妝品許可證的文件要求 

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

1:申請表格 Application forms

2:手續費 Challan of fee deposited

3:申報表 Declaration form

4:主要計劃(藍圖)Key plan (Blue print)

5:地址圖(藍圖)Site plan (Blue print)

6:擁有處所的根據 Basis of possession of the premises

7:房屋所有權的證明，如果出租 Proof of ownership of the premises, if rented

8:公司章程證明(核證副本)Proof of constitution of the firm (Certified copy)

9:根據 1940 年《藥品和化妝品法》，經營者/合伙人/董事未被定罪的宣誓書

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

10:德里藥房理事會注冊證書的核證副本/注冊藥劑師的經驗證書/合資格人士的資格證書

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

qualification certificates

1. 生物數據的表格 Bio-data form

2. 注冊藥劑師/合資格人士關于全職工作的誓章，須經公證人正式證明

Affidavit of Registered Pharmacist/Competent person regarding fulltime

working with the firm duly attested by Notary

3. 注冊藥劑師/主管人員聘書(如已聘用)Appointment letter of Registered

Pharmacist/Competent person in charge, if employed person；

四、從業人員要求 Requirements on Practitioners:

國家政府指定的許可證頒發機構頒發化妝品生產許可證。制造商須確保在有合資格及合資格的技術人員在場的情況下進行生產，而其中最少一名人員須具備下列學歷 

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 年印度藥劑理事會根據《藥劑法》批準的藥學文憑;或

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

2:是根據 1948 年《藥劑法》注冊的;或

Is registered under the Pharmacy Act, 1948or  

3:已通過中級考試，其中一科為化學或獲發牌當局認可為等同中級考試的任何其他考試。許可證頒發當局還命令根據該法令任命的檢查員對整個房舍進行檢查，在批準或拒絕在印度的美容許可證之前，必須在該處進行作業。一份詳細的報告被提交到許可機構，然后決定是否授予化妝品許可證在印度或不。

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、化妝品許可證的有效性 Validity of the cosmetic license:

該登記的有效期為 3 年，之后需要重新辦理證書才能繼續營業 

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、特別說明 Notes:

禁止對進口化妝品進行動物試驗。

Ban On Animal Testing on Imported Cosmetics

在港口辦事處清關貨物時，制造商必須向有關港口辦事處提交一份承諾書，聲明該化妝品在 2014 年 11 月 12 日或之后未在動物身上進行測試。

(根據通告，文件編號 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、其他服務 Other Services

如果客戶需要，我司可提供以下服務：

1. 財務稅收服務 Financial tax services

2. 商標注冊服務 Trademark registration services

3. 公證認證服務 Notarization and attest service

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