États-Unis d'Amérique
Renseignements non divulgués
22. Are other applicants for marketing approval for their own versions of a previously approved pharmaceutical or agricultural chemical products permitted to rely on data submitted by the earlier applicant? If so, how long a period of exclusivity is given the earlier applicant before such reliance becomes possible.
This scenario has not arisen in practice, however, it is considered that if the information or data relied upon is in the public domain and no longer qualifies as "secret information", the prohibition against the use of such information including subsequent applicants would not apply. The Protection Against Unfair Competition Act, 1998-20 does not specify a specific time span for the protection of secret information.