États-Unis d'Amérique
Renseignements non divulgués
24. 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.
According to section 8 subsection 5: "Subsection (4) shall be construed as precluding, in particular, any person other than the person who submitted undisclosed tests or other data, the origination of which involves a considerable effort, from relying on such data in support of an application for product approval for a reasonable period of time after the submission of those tests or data and the period of time shall be determined by the Court, taking account of the nature of the data and the person's efforts and expenditure in producing them, and shall normally not be less than five years."