News & Insights

For further information,
please contact:

Can Sozer

Senior Associate

Legal Alerts

January 11, 2017

Turkey Tightens Deadlines and Revises Fees for License Applications in 2017

Legal Alerts
Healthcare

Recent Development

The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced deadlines and procedures for the payment of scientific analysis and assessment fees in license applications subject to the new price tariff in 2017.

Background

The TİTCK announced a new price tariff for medicine applications in 2017. Scientific analysis and assessment fees payment deadlines were updated along with the price tariffs.

What the announcement says

The TİTCK advises pharmaceutical companies to meet the new deadlines for the payment of scientific analysis and assessment fees for their ongoing license applications. The finalization of license applications may be delayed if there is failure to comply with the deadlines.

The deadlines and procedures below will apply to the ongoing license applications in 2017:

  • Companies should pay their scientific analysis and assessment fees between January 2 – February 17, 2017.
  • The evaluation process on the license applications of the companies who have paid the fees by February 17 will continue, whereas the applications of the companies who have missed the deadline will be waitlisted until November 30, 2017.
  • Applications for scientific analysis and assessment fees that are not paid by November 30 will be cancelled.

 

Conclusion 

Pharmaceutical companies should take note of the new deadlines for payments to prevent any delay in their license applications and should follow any further announcements made by the TİTCK.