Filing An Abridged Application Within Terms Of Rdp Does Not Constitute Unfair Competition

Regulatory data protection (RDP) terms are dealt with only in the Licensing Regulation of the Ministry of Health (MoH). In principle the provision grants the protection of data for six years following the first marketing authorisation for a drug granted in the European Union. However, there is no mechanism to prevent a generic drug company from using the data before the term expires. The MoH interprets the provisions as granting market exclusivity and allows abridged marketing authorisation applications filed by using the data of the originator within the RDP term. Generic companies generally choose to take advantage of this interpretation to be ready to launch as soon as an RDP term has expired.