Manufacturer of Drugs, Medical Devices and/or Cosmetics Outside the State of Connecticut
Purpose:
This registration is required for businesses that reside outside the State of Connecticut and manufacture or repackage controlled substances, legend drugs, over-the-counter drugs, medical devices (legend or non-legend), or cosmetics (excluding soap).
Prerequisites:
Proof of registration with the Food and Drug Administration (FDA) and a registration with the state in which your company resides, if applicable.
Required Documentation:
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Complete the ONLINE application below and attach the required documents
Applications, Forms & Other:
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- Please note that this is a one-time informational filing and does not need to be renewed.
- Food and Drug Administration (FDA) registration from their website should be included with the application. For virtual manufacturers, please provide your labeler code and the current registration of your contract manufacturer.
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Provide a copy of your home state license, if applicable. If your home state does not provide a registration please provide a letter from your state indicating that registration is not required.
Application Fee:
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There is no fee for this registration. (Please note that you will not receive a certificate for this registration, and all applications will only be accepted using the online application.)
Email Address: