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DMFs are accredited by the Certified Generic Drug Regulatory Professional (CGDRP) program. The CGDRP is a regulated program through which ASMP accredits DMFs and offers accreditation testing and oversight to DMFs in all aspects of DMF development. Accreditation is the reflection of a DMF’s quality, accuracy, and professionalism. The DMF must be an original document, appropriately formatted in accordance with ISO 30500–1 and clearly marked with the ASMP logo and the UN number. A DMF holder must provide evidence that DMF is a true copy of the original DMF, and that the holder is the rightful owner of that DMF.

DMF holders must support their assertions by appropriate original and/or certified copies of the relevant patent, trademark, and other necessary documents or certified translations as evidence of the right to the mark. The holder must establish that the mark is compliant with the 1955 Convention and any exceptions (e.g., representation of the proprietary extension).

DMF holders should ensure that their DMFs are up to date and readily available, and should submit any necessary updates to the FDA. DMF holders are responsible for updating their DMFs to show current maintenance, and provide documented proof of the updated information upon request by the FDA. Failure to provide the FDA with this documentation will result in DMF fees being noted on the FDA's acceptance of the generic.

If the FDA receives any documentation from the holder that does not satisfy the requirements for a DMF, it will issue a CRFI #1 (DMF Failure Notification) to the holder. The CRFI #1 is sent in a timely manner to the original DMF holder or his/her designated counterpart from the DMF holder's PMC.

The CRFI #1, which is in PDF format, includes a brief description of an issue with the DMF; specific documentation related to the issue; and an order to correct the issue or prepare an updated DMF. DMF holders are encouraged to review the information included on the CRFI #1 as soon as possible as DMF holders are directly responsible for providing proof of DMF update documentation and correction to the FDA. DMF holders are also responsible for: d2c66b5586

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