COSMETIC REGISTRATION SERVICES
Dossier Support Services: Fresh 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.
FRESH APPLICATION FOR REGISTRATION
A “Fresh application” for registration of imported cosmetics in Form 42 has to be made in case when the brand is being registered by an Importing Entity for the first time.
If the Legal Manufacturer is one common entity, then A single application may be made in Form 42 for any number of brands manufactured at one or more locations by such legal manufacturer.
Finally, the office of DCGI, CDSCO will issue a single registration certificate in Form 43 in an application for registration of import of cosmetics for any number of brands/products manufactured at one or more locations by a single manufacturer.
In case of a legal manufacturer NOT having its own manufacturing site, but getting products manufactured at an overseas manufacturing site owned by someone else, then all such products can be clubbed in a single application.
legal documents
All the legal documents in Step no 2 as highlighted in the earlier blog need to be prepared for a renewal application for registration.
A valid and attested Power of Attorney, Free Sale Certificate, Manufacturing License.
Technical documents
Non animal testing declaration, Heavy metal declration and a declaration of no change in product specifications, formulations etc.
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.
NKG Insight:
– If an application for renewal is missed to be submitted before the date of expiration on the online CDSCO SUGAM portal , then it cannot be renewed. In such a case the regulatory dossier needs to be applied as a fresh registration application with all set of documents and applicable fees.
– In a case, a registration certificate is expired and fresh application for registration is filed, the applicant will be granted an independent and altogether new registration certificate bearing a unique registration certificate number different from the previous granted certificate number.
– If an applicant does NOT intend to renew some of the earlier approved products and/or categories, he can do so by applying for a partial renewal
– An applicant cannot renew any product/size/variant or category which has not been approved under a valid registration certificate.
in numbers from
regulatory track record
5000+
INTERNATIONAL BRANDSRegistered
100k+
Products Registered
100%
transparency & trust
proudly SUPPORTING
trade commiSsions
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
member of
indian beauty & hygience association
our renowned
associates
contact nkg
we help you meet your compliance needs
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.
