What is FDA License?
The Food and Drug Administration (FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
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.
Check out the FDA License Video
Who can get FDA License?
Drug Products
Medical Devices
Cosmetics
Color Additives
Food
Beverages
Dietary Supplements
Labeling Products
Document Required for FDA License
- Covering letter (with brief of company, categories of products, dosage forms proposed to manufacture)
- GRN generated by payment of fees
- Site Plan and layout of the building with name, address, scale, and measurements of the Area as per Schedule- T requirement (For Ayurvedic, Siddha, and Unani) & as per Schedule- M requirement (Allopathic Medicines) & as per Schedule- M - II requirement (For Cosmetics).
- Self-attested copies of documents pertaining to the possession of premises such as, Register ownership / rent / lease / allotment letter / Possession Letter, Tax Receipt, (Documents should be registered with appropriate Authority). Consent to establish from Maharashtra Pollution Control Board.
- List of Directors, Partners, Trustees ,along with ROC Copy Registered Partnership deed, Trust deed (As applicable)
Role of Shamkris and Process of FDA 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:
- 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 License?
FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured
The FDA Licensing Process
1. Review the technology with the scientist and the Technology Transfer Specialist.
2. Review the various types of licenses available for use online.
3. Submit a License Application to the Agency-level FDA Technology Transfer Program. E-mail to: FDAInventionLicensing@fda.hhs.gov.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products.