Features included in your subscription:
- How to get US FDA Drug Import License?
- Every company who want to import drug license from US
- Needs to be FDA Import Drug License
- It’s mandatory to have licence since 2004
- FDA Provides guidelines to get FDA Import License
- All provided guidelines has to be fulfilled
- It takes 90 days to get FDA Import license
- Subscription Steps
- Fill the online registration form
- Make One Time Payment
- Our team collects all documents
- Dedicated A/C Manager Assigned for your work
- Weekly Update for your work
- Your US FDA Drug Import License Register Completed.
- Tracking and Monitoring
- Payment receipt sent to you by email
- Receive automatic email alerts
- One year free support
To import drugs into the United States, you must comply with the regulations set by the U.S. Food and Drug Administration (FDA). The FDA does not issue a specific “Drug Import License” but requires drug importers to register their establishments and follow specific procedures. Here’s an overview of the process for drug importation:
1. Establish DUNS Number: Before registering with the FDA, you may need to obtain a Data Universal Numbering System (DUNS) number, particularly if you are not already registered with the FDA. The DUNS number is provided by Dun & Bradstreet and may be required for FDA registration.
2. Register with FDA: Drug importers must register their establishments with the FDA through the Drug Registration and Listing System (DRLS). This registration includes details about your business and import activities.
3. Obtain National Drug Code (NDC): If you are importing drugs for commercial distribution in the United States, you will need to obtain a National Drug Code (NDC) for each drug product. The NDC is a unique identifier for drugs, and it is required for listing the drug with the FDA.
4. Comply with Drug Labeling Requirements: Imported drugs must comply with FDA labeling requirements, including proper drug identification, instructions, and warnings. The labeling should be in English, and any foreign language labeling should have an English translation.
5. Adhere to Good Manufacturing Practices (GMP): If you are importing drugs for commercial distribution, ensure that the foreign drug manufacturing facilities follow Good Manufacturing Practices (GMP) or their equivalent as required by the FDA.
6. Submit Drug Listing Information: All imported drugs must be listed with the FDA. This includes providing detailed information about each drug, including its NDC, packaging, and labeling.
7. Address Drug Importation Compliance Issues: The FDA may inspect drug importers’ facilities and review their importation processes to ensure compliance with FDA regulations. Address any issues or observations raised during inspections promptly.
It’s important to note that the drug importation process can be complex, and specific requirements may vary depending on the type of drugs being imported and the intended use. For detailed instructions and requirements, refer to the FDA’s official website (www.fda.gov) and consult relevant guidance documents. Additionally, seeking the assistance of regulatory experts or consultants familiar with drug importation and FDA regulations can be helpful in navigating the registration and importation process successfully.https://www.corpregistered.com/fdaconsultingimport