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What You Need To Know About The FDA GDUFA Self Identification Requirements

30

Apr

2019

Who is required to self-identify?

As per the federal law, FDA self-identification is going to start from May 1st, 2019 and the facilities are required to submit their files as soon as possible. Each and every Drug company is requested to update, re-confirm and submit the self-identification form before June 1st, 2019. The manufacturer or any company who plans to become a manufacturer of human generic drug APIs or FDFs are required to self-identify. Any organization or company that package the FDF of human generic drugs into the primary container/closure system will also have to go through this process.

How we can assist for self-identification?

FDA basics can assist you to self identify your facility within two working days and also assist to obtain  FEI number.

What Information I have to provide for self-identification?

You have to provide name, address, contact details, information about operations at your facility, FEI number and DUNS number We can assist you to obtain the DUNS number and FEI number without any additional fee.

Self-identification should be renewed every year?

Yes, self-identification should be updated every year between May 1st and June 1st.

Are All Sites, Facilities, as well as Organizations that must strictly Self-Identify Also Required to Pay Facility Fees?

No. The manufacturers or the companies who are planning to become a manufacturer are supposed to pay the fees. If the company meets the self-identification requirement needs, then they are requested to pay only an annual FDF fee or one annual API fee. If you have an organization or a site that only performs tasks like repacking, testing, or relabeling, then it is not necessary for you to pay the fee.

Where I can verify my self-identification status?

https://www.fda.gov/industry/generic-drug-user-fee-amendments/self-identification-generic-drug-facilities-sites-and-organizations

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