DRUG REGISTRATION SERVICES
Renewal or Re-Registration Form 40
Definition or What does it mean
Under the Drugs & Cosmetics Act 1940 & Rules 1945, the permissions issued to applicants for registration certificates and import licenses are valid for a particular and defined time period. Such registration certificates and import licenses are expected to be renewed within the stipulated time by submitting prescribed documents and fee before expiration if the applicant intends to continue such permissions issued in its favor.
An application for re-registration shall be made to the Licensing Authority (CDSCO) in Form 40, either by the manufacturer himself, having a valid Wholesale License for sale or distribution of drugs or by his authorized agent in India having a valid wholesale License for sale or distribution of drugs. In case the re-registration/renewal of registration application is filed after the expiry of Registration Certificate, a fresh registration application needs to be filed.
Who Regulates?
CDSCO.
An Online application has to be submitted on SUGAM Portal https://cdscoonline.gov.in/ for approval for the same.
Government Fees:
|
Application Form |
Permission |
Government fees |
Validity |
|
Form 40 Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945 |
Form 41 Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945 |
USD 10000 for Each Plant or Site Registration USD 5000 for each product |
3 years from Date of issue, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. |
|
Form 8 Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 |
Form 10 Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945 |
INR 10000 |
3 years from Date of issue, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. |
|
Form 8A Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945 |
Form 10A Licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945 |
Rs 10000 for each product Rs 1000 for each subsequent product |
3 years from Date of issue, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. |
CHECKLIST OF DOCUMENTS
At the time of application for renewal of registration or re-registration, the application is to be made 9 months before the expiry of the Registration Certificate. In addition regulatory documentary compliance like Form 40, POA, GMP / COPP, Registration certificate, DMF (soft copy if no change), License (sale or manufacturing License of drugs of the agent) etc., the following undertaking / information is to be submitted:
- Undertakings by the manufacturer or his authorized agent in India in respect of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorization, and/or not of standard quality report of any drug pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the drug is marketed/sold or distributed.
- Undertaking by the manufacturer or his authorized agent in India in respect of any change in manufacturing process, or in packaging, or in labelling or in testing, or in documentation of any of the drug pertaining to this Registration Certificate.
- Undertaking by the manufacturer or his authorized agent in India in respect of any change in the constitution of the firm including name and /or address of the registered office/ factory premises operating under this Registration Certificate.
- Details of drugs imported in India during the last three years.
- Submission of original RC issued.
Validity of License
Validity of License is 3 Years from date of Issuance
Why NKG for Drug Regulatory Services
NKG experts assist clients with successful approval of such permissions. Our team understands that ensuring timely submission of dossiers for renewal or re-registration are critically important to ensure that there is neither any regulatory gap nor there is any disruption in supply chain of its clients.
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5000+
INTERNATIONAL BRANDSRegistered
100k+
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100%
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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
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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.
