Recent Developments In Pharmaceuticals

The sensitive political nature of healthcare and pharmaceuticals has made this sector one of the most heavily regulated in Turkey. Parallel with scientific developments in pharmaceuticals, the relevant legislation has been amended and updated to embrace the new realities. The central piece of legislation on licensing pharmaceuticals is the Regulation on Licensing Medicinal Products for Human Use¹ ("Regulation"). On 22 April 2009, several amendments were made to the Regulation, and in this article we will review them and examine implementation of the Regulation.

There is a new concept introduced by the Regulation under the "Definitions" section, and that is "co-marketing," allowing identical products manufactured in the same release batch – with the same qualitative and quantitative composition and the same pharmaceutical form – to be marketed under different trade names. Another amendment made under "Definitions" relates to the generic product. Although the