Homeopathic Registration and Drug Listing with FDA
FDA define Homeopathic Drug as Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.
All domestic firms which manufacture, prepare, propagate, compound, or process homeopathic drugs must register with FDA as drug establishment and list homeopathic drug products with US FDA.
All foreign firms who import homeopathic drugs or offered for import into U.S should register their establishment and list drug products with FDA. Drugs that are not properly listed as required are considered to be misbranded and may be subject to regulatory action.
Homeopathic Drug registration information must be renewed annually. Any additional updates to drug listing information must be submitted in June and December of each year. FDA no longer accepts submission in paper format unless there is a waiver is granted. Electronic submission of Homeopathic drug listing should be done by creating a SPL (Structured Product Labeling).
Liberty Management Group Ltd, provide assistance in homeopathic drug establishment registration, homeopathic drug listing and SPL preparation and submission to FDA ESG.
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|