Regional Court of Appeals: The Decision of the TMMDA of Refusal of the Applications of the Original Medicine Owners to Obtain Information on Reference Product is Unlawful
As per article 9 of the Regulation on Authorization, which regulates “Abridged Application”, if a pharmaceutical has been authorized before, it is not necessary to repeat the tests and research, and the data of these tests doesn’t have to be submitted for authorizing again, only referencing to the authorization information of the original pharmaceutical that is pre-licenced is sufficient.