FDA TRADE LICENSE
What is FDA Trade License?
FDA helps facilitate trade between the U.S. and foreign trading partners with a new export certification program for food | FDA. The .gov means it’s official. The site is secure. The ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
For the purposes of the laws enforced by the FDA, Foreign Trade Zones are part of the United States and the movement of regulated products into or out of such zones, including export, constitutes interstate commerce.
The FDA’s primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations.
Much of this regulatory-enforcement work is not directly related to food or drugs but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.
Why this License is Required?
In order to make sure that food from the local market is hygienic, the Food and Drug Administration (FDA) Maharashtra will soon be issuing a notice to vendors in local markets to obtain a food safety license from the authority. Everybody who is dealing with food needs to have registration or license with us.
Who can get FDA Trade License?
Drug Products
Medical Devices
Cosmetics
Color Additives
Food
Beverages
Dietary Supplements
Labeling Products
Document Required for FDA Trade License
- Application Form No.19/19A/19B/19C as applicable.
- Application in Form 19 is required for Retail license in Form 20, 21 and Wholesale license in Form 20B & 21B.
- Application in Form 19B is required for Retail Homeopathic license in Form 20C and Wholesale Homeopathic license in Form 20D.
- Application in Form 19C is required for Retail license of Sch. ‘X’ Drugs in Form 20F and Wholesale license for Sch. ‘X’ drugs in Form 20G.
- Application in Form 19A is required for Retail Restricted license in Form 20A, 21A (required only at the places where retail medical shop are not existing)
- Firm’s constitution documents
- If proprietorship firm – photo ID.
- Partnership – Partnership deed and Registration receipt of fees paid to Registrar of firms.
- Pvt. Ltd./ Public Ltd./ LLP. –certificate of incorporation given by Registrar of companies.
- Trust deed – Trust Registration documents given by charity commissioner.
- HUF – HUF deed.
- Society – Society deed and registration certificate from relevant authority.
- Government – Letter from Head of Department
- Details of proprietor/partner/ Director/Trustee etc.
- ID proof
- Rent/Lease agreement
- Premises ownership documents
- NOC
- Plan lay out
- Cold storage proof (If applicable) – purchase proof of refrigerator/ cold room / deep fridge.
- For Retail License (Documents of Pharmacist) - Services of Registered Pharmacist
- For whole sale License (Documents of Competent Person)
Role of Shamkris and Process of FDA Trade License
Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.
The License process described below:
- Advertising for the document required
- Preparation of documents as per application & list of documents.
- Application File
- Inspection by the department if required
- Liaison department
- License issued
- Yearly compliance if applicable
- Renewal when due
Advisory for the document required
Preparation of documents as per application & list of documents.
Application File
Inspection by the department if required
Liason department
License issued
Yearly Compliance if Applicable
Renewal when due
Who can issue the FDA Trade License?
FAQ
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food | FDA. The .gov means it’s official. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.