United States of America

Fiji

Undisclosed Information

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.

(Response to Questions 23 and 24) There are no provisions for test data regarding pharmaceutical and agricultural products submitted to the Government in order to obtain market approval in Fiji. However, please note that under section 3A of the Patents Act, it is not an infringement for persons to make, construct, use or sell the patented invention in respect of a pharmaceutical product or substance solely for reasons related to the development and submission of information required under any laws of Fiji or of another country.