Aug. 23, 2022
To facilitate communication, CVM strongly encourages foreign VMF holders to appoint an agent who is familiar with FDA regulations, guidances, and procedures. However, there is no requirement for an agent for any VMF, foreign or domestic. An agent for a VMF is not the same as an agent for FDA’s Drug Listing and Registration System (DRLS), which is required. We do not require agents or contact persons for a VMF be located in the United States, although this is recommended. VMF holders should provide the name, telephone and fax numbers, email address, and specific responsibilities of the contact person and the responsible official (if different from the contact person).
Source from FDA
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