What is FDA License for Import Products?
All imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products. The FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA Import Process
FDA-regulated products imported into the U.S. must comply with the same FDA laws and regulations that apply to domestic products. Entries are submitted to U.S. Customs and Border Protection (CBP) which then refers entries of FDA regulated products to FDA for review.
• Products considered higher-risk and entry submissions with incomplete or inaccurate information are flagged for manual review by FDA to determine the admissibility of the product.
• FDA’s screening tool uses various sources of information to assess risk; for example, a firm’s previous compliance history or known compliance problems with a certain product.
• FDA’s entry reviewers use various sources of information to determine admissibility; for example, using FDA’s registration database to verify whether a declared manufacturer of a drug or medical device product complies with facility registration requirements.
• FDA entry reviewers look for complete and accurate data in the entry submissions. Providing FDA with complete and accurate data expedites the review of your entry.
• Imported items should not be distributed into commerce until FDA has determined admissibility.
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 Import Video
Who can get FDA Import License?
Drug Products
Medical Devices
Cosmetics
Color Additives
Food
Beverages
Dietary Supplements
Labeling Products
Document Required for FDA Import License
- Covering Letter
- Original Power of Attorney
- Copy of Import permission for new drug (s) in Form-45 (formulation) or in Form-45A (new bulk drug substances)
- Copy of Whole sale Licence(20B/21C) or Manufacturing Licence of the Indian agent/Corporate office address
- Authorization letter
- A legal undertaking from Indian agent providing the name, designation, signature telephone number, e-mail & fax of the authorized person responsible for the signing of documents Form 40, Power of Attorney & Form 9 for the registration & issue of Import License
- A legal undertaking from manufacturer providing the name, designation, signature telephone number, e-mail & fax of the authorized person responsible for the signing of documents Form 40, Power of Attorney & Form 9 for the registration & issue of Import License.
- Companys authorization letter (in original) for the bearer to submission and collect letter.
- A legal undertaking from manufacturer for submitting of fresh Power of Attorney at the time of renewal application
- Schedule D (I)
- Schedule D (I) and Undertaking duly signed, dated and seal/stamped with name and designation of the authorized signatory of the manufacturer or his authorised Indian agent.
- Any other supportive document to be given with respect to Schedule D I
- Notarized Plant Master File
- List of Major equipments in Production and QC
- List of key personals with qualification, experience and their responsibilities
- Organizational Chart
- QA functional Chart
- Plant Layout
- HVAC system drawing
- Water system drawing
- Pressure differential drawing
- Personal movement drawing
- Material movement drawing
- Distribution, Complaints & products recall SOP
- List of Contract Manufacturing/analysis
- Schedule D (II)
- Schedule D (II) and Undertaking duly signed, dated and seal/stamped with name and designation of the authorized signatory of the manufacturer or his authorised Indian agent.
- Any other supportive document to be given with respect to
- Schedule D II
- Notarized Drug Master File
- Process flow chart
- Manufacturing process development report
- Control of critical steps
- Process validation report of three batches
- List of Impurities and related substances
- List of Residual solvents and its limits
- Testing procedure of impurities, related substances and residual solvents
- Source and maintenance of reference standards
- Container and closure system and its testing procedure
- Batch determination: batch numbering system & batch size
- Specification of the products & material used in its manufacturing
- Justification of the Specification
- Certification of analysis of five batches
- Process validation repLabels and Package insertort of three batches
- MSDS
- Details of PMS studies
- Stability data both accelerated and real time (As per ICH Q1A (R2) and WHO TRS 953)
- Long term stability data
- Accelerated stability data
- Stability study summary
- Copy of Original Notarised
- Manufacturing Licence/Product authorisation certificate , in case of China
- GMP Certificate(Duly Apostilled/Notorised copy)
- COPP Certificate (Duly Apostilled/Notorised copy)
- FSC Certificate (Duly Apostilled/Notorised copy)
- Attested/Appostilled copy of
- Product Registration Certificate (SFDA), in case of China
- Certificate of suitability from EDQM
- Original label /specimen label complying with Rule 96 and indicating name of the drug with pharmacopoeial specification, the importer name & address as per Wholesale license and Import License number. If proposed draft label/package insert whereever applicable, then duly attested either by the authorised Indian Agent or by the manufacturer is required to be submitted along with the application.
- Form 40 (Generated Online after submission of application and above Documents)
- Payment Challan (Payment will be done online)
Role of Shamkris and Process of FDA Import 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
- Yearly Compliance if Applicable
- Renewal when due
Who can issue the FDA Import License?
Ayush relates to manufacturing of herds and other products which are utilized for Industrial purposes.
The government department regulates the manufacturing of Ayush. The ministry of Ayush carries of the regulation of Ayush in India. This ministry was considered as the Department of Indian System of Medicine and Homeopathy.
The ayush manufacturing license is utilised for manufacturing of medicines and products which come under the purview of Ayush category. However, the manufacturer has to set up his own plant for the process of manufacturing.