The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website the draft Regulation on Variations in Medicinal Products for Human Use (the “Variation Regulation”) and the relevant guidelines thereof.
The draft Variation Regulation was prepared based on EC Regulation No. 1234/2008, EC Regulation No. 712/2012 and EC Regulation No. 2001/83 to establish the procedures and principles for the variation applications for medicinal products for human use. Variation means any amendment to the information submitted during the authorization application; product information; any condition, obligation or restriction that may affect the authorization; and information on packaging or manuals. In this scope, the Variation Regulation identifies different classes of variations and sets the requirements for the authorization holders during their variation applications to the TİTCK.
In addition to the Variation Regulation, the TİTCK also published the draft Guidelines on Variations in Medicinal Products for Human Use and the draft Guidelines on the Classification of Variation Applications to further clarify the practical issues concerning variation applications.
The draft Variation Regulation, the draft Guidelines on Variations in Medicinal Products for Human Use and the draft Guidelines on the Classification of Variation Applications are available on the TİTCK’s website (in Turkish).
The TİTCK continues to provide licensing procedure guidelines for companies engaged in medicinal products for human use. Companies should carefully review the requirements set forth under the draft Variation Regulation as well as the relevant draft Guidelines to ensure compliance when submitting a variation application to the TİTCK.