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Regulatory Focus™ > News Articles > 2020 > 8 > FDA explains transfer of ownership policy for generics

FDA explains transfer of ownership policy for generics

Posted 28 August 2020 | By Denise Fulton 

FDA explains transfer of ownership policy for generics

The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.
The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.
To transfer an application, the current owner must submit documentation stating that all rights are transferred to the new owner, a change of ownership request, and a consolidated list of applications that are being transferred. The new application owner must submit a signed application form as well as an acceptance letter that details their commitment to all agreements and conditions the current owner made, as well as the transfer’s effective date. The new owner also must certify that they have a complete copy of the approved application or will request one from the FDA.
Documentation will be reviewed by Orange Book project managers and/or pharmacists; incomplete requests will be returned for additional documentation prior to approval, according to the MAPP.
The MAPP stresses that ownership changes due to corporate mergers and acquisitions are not considered to be transfers of ownership. Instead, application owners are instructed to submit Form FDA 356h with a cover letter containing new ownership information and demographic details. These submissions must be reviewed and approved by an Orange Book pharmacist or designee.


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Tags: FDA, generic drugs, US