CDSCO Registration Document Checklist for Pre-screening of Application

  • August 20, 2022
  • Registrationwala
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CDSCO Registration for cosmetic imports includes two levels of assessment. The first is the application and the document assessment, also known as pre-screening. At this level, the Central Drug Standard Control Organization scrutinizes your application and your documents. The core of its assessment is the correctness of the documents that you submit.

This article provides you a document checklist for pre-screening of your CDSCO Approval application

Cover Letter

Cover Letter should entail the your purpose behind applying CDSCO certificate. You have to clear, concise and convincing when drafting this particular document.

Application Form 42D

Needless to say, you should make no mistake as you enter your details in the application form. For the pre-screening, the details that CDSCO scrutinize is as follows:

1.       The application form should be signed & stamped by you.

2.       The details of the cosmetic product, including:

a.       Name of the product

b.      Variant of the product

c.       Actual manufacturer details

d.      The categorization of the product

3.       Name of your Authorized Agent, the one filing the application on your behalf.

4.       Name and address of the factory premises.

Fee Challan

You need to provide TR-6 Challan specifying the CDSCO registration fees. The registration fee is USD 1000 for each proposed brand. Don't deposit this document if your challan doesn't have the following:

1.       Bank's stamp

2.       Name of the drug

3.       Address of the manufacturing site

4.       Head of the fee details

Copy of the valid license

Copy of the valid whole sale license or Manufacturing license for the Indian Origin manufacturer

Authorization letter from the company

The company's authorization letter that let's the authorized agent collect and submit the documents.

Undertaking of the Authorized Indian agent

Provide an undertaking that contains the name and designation of the Authorized Agent who is representing your certification requirements to the CDSCO.

Plant Master File

Provide a notarized copy of the plant master file

Master file

Provide a Notarized copy of the master file

Product Registration certificate

Provide a copy of the product registration certificate from the country in which the cosmetic product is manufactured.

Labels of the cosmetic product

Provide the details of the label to be posted on the packaging of the product. The label should entail the following:

1.       Name of the cosmetic product

2.       Name of the manufacturer

3.       Ingredients of the cosmetic product.

4.       Wholesale License number

5.       Import license number 

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