COSMETIC REGISTRATION SERVICES
Dossier Support Services: Endorsement Application for Registration
Gazette Notification G.S.R 426(E) issued by Government of India has made registration of imported cosmetics with CDSCO mandatory.
The Government mandated that from 1 April 2013, imported Cosmetics shall be Subject to Registration with the CDSCO Office, FDA Bhawan, Ministry of Health and Family welfare, India
Under the RULE 21 of Drugs & Cosmetics Rules 1945, All cosmetic products that are imported for sale in India need to be registered with the licensing authority.
NKG is the titanium standard in providing regulatory dossier creation services related to Imported cosmetic registration of overseas brands in India. Having been behind thousands of submissions and approvals in the past years, NKG team has developed its own blueprint of preparing the regulatory dossier which has proven successful time and again and is easy to follow.
An “Endorsement Application” in Form 42 is submitted when an applicant has already been granted a “Fresh Registration Certificate in Form 43. By the nature of the industry progression , customer expectations for new products, shades, and emerging beauty trends , almost all cosmetic brands keep developing new products to launch in the markets.
This gives rise to a regulatory exercise. From our “Imported Cosmetics – What is a Cosmetic, Product Categorization & Government Fees” we already know that cosmetic registration is also a SKU specific exercise.
Brands and importers need to keep adding or endorsing newer products to their existing registration certificates which have been granted by CDSCO. Different types of new launches will require respective regulatory documentation, government fee if applicable and application processing for approval to be granted.
There are 3 major types of endorsements as explained below:
ENDORSEMENT OF NEW PRODUCTS & VARIANTS
Regulatory documents
A detailed list of documents and step by step procedure to prepare a correct and complete regulatory dossier for registration of imported cosmetics is detailed here.
Timelines
The internal targeted timeline of CDSCO for processing of such application is 90 days from submission of this application whereas the notified timeline in the ACT is 6 months from date of submission.
Government Fee
- A fee of USD 2000 or its equivalent Indian Rupees per category of products as mentioned in Column 3 of the list enclosed in the “Guidelines to Registration of Imported Cosmetics” issued by CDSCO.
- A fee of USD 50 per variant
ENDORSEMENT OF NEW SIZES OF REGISTERED PRODUCTS
Regulatory documents
In case of New Sizes of a Registered Products we will need Below documents for adding New Sizes:
- Declaration from Legal Manufacturer or Brand Stating the request of addition of new Size and declaring that there has been no Change in composition, Specifications or Manufacturing location.
- Non Animal Testing Declaration
- Heavy metal Declaration
- Artwork for the New Sizes
Timelines
The internal targeted timeline of CDSCO for processing of such application is 90 days from submission of this application whereas the notified timeline in the ACT is 6 months from date of submission.
Government Fee
There is NO government fee for addition of new sizes in an already registered product under a valid registration certificate.
Endorsement of New Manufacturing Premises
Overseas Brand holders routinely set up new manufacturing locations or get cosmetic products manufactured by contract manufacturers. Many a times, new manufacturers are appointed to manufacture new products.
This gives rise to a regulatory exercise.
A new manufacturing location whether owned or contract manufacturing location which has not been earlier approved under a valid registration certificate has to be added by making an Endorsement Application for registration.
Regulatory documents
In case of new site manufacturing new product:
A detailed list of documents and step by step procedure to prepare the a correct and complete regulatory dossier for registration of imported cosmetics is detailed here.
In case new site manufacturing already registered product:
Legal Documents: A valid and attested Power of Attorney, a valid and attested manufacturing license of the new manufacturing location.
Technical documents: Artworks of products being manufactured at the new locations, Declaration no change due to change in manufacturing site.
Timelines
The internal targeted timeline of CDSCO for processing of such application is 90 days from submission of this application whereas the notified timeline in the ACT is 6 months from date of submission.
Government Fee
In case of new site manufacturing new product:
A fee of USD 2000 or its equivalent Indian Rupees per category of products as mentioned in Column 3 of the list enclosed in the “Guidelines to Registration of Imported Cosmetics” issued by CDSCO.
- In case new products have to be registered in an already paid category under a valid registration certificate then the category fee for the paid for category is not required to be deposited.
In case new site manufacturing already registered product:
There is NO government fee for addition of new manufacturing location sizes in an already registered product under a valid registration certificate.
NKG Insight:
– In case new products have to be registered in an already paid category under a valid registration certificate then the category fee for the paid for category is not required to be deposited.
– Validity of an endorsement registration certificate will not be a separate 3 years. The endorsement registration certificate in Form 43 will expire on the same date of the main registration certificate.
– In case, manufacturing premises are already registered, then the manufacturing license is not required to be re-furnished in an endorsement application.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
