Estados Unidos de América

Bahrein, Reino de

Información no divulgada

23. 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.

As explained in the response to question 22, by virtue of Article 2 of the draft Law on the Protection of Trade Secrets, other applicants for marketing approval for their own versions of a previously approved pharmaceutical or agricultural chemical products are not permitted to rely on data submitted by an earlier applicant before the lapse of 5 years from the date of marketing approval in Bahrain of the original pharmaceutical or agricultural products which utilise new chemical entities.