The new Regulation on the Authorization of Human Medicinal Products has been published in Official Gazette dated December 11, 2021. Some of the Main changes are;
The new regulation introduces Hybrid applications among the types of abridged applications. It is a development arising curiosity on the implementation of Hybrid applications.
The Data Protection period has been kept the same as 6 years starting from the date of the first application within the Customs Union for generic applications.
Obtaining Sales Permit has been included to the Regulation again which was repealed in the former Regulation in 2009.
These changes provide a clearer understanding of the Authorization requirements for Human Medicinal Products as well as the clarification of the terms thereof.