TİTCK Announces New Procedures for License Applications

The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced new procedures for the medicine licensing process depending on the payment status of the scientific analysis and assessment fees.

Background

Scientific analysis and assessment fees are among the mandatory fees in the medicine licensing process. In early January, the TİTCK announced an update to scientific analysis and assessment fees – including price tariffs – and stated that the deadline for the payment of scientific analysis and assessment fees was February 17, 2017. Companies that missed the payment deadline have had their license application waitlisted until November 30, 2017. Companies that do not pay their scientific analysis and assessment fees by November 30 will have their applications cancelled.

For more information on scientific analysis and assessment fees, please refer to our previous legal alert of January 11, 2017.

What the Announcement Says

The TİTCK recently announced the following procedures on its website.

• Applications that are in the licensing process, but whose scientific analysis and assessment fees were not paid by February 17, 2017, will be waitlisted (the “Process Waiting List”).  For such applications:

– If the laboratory analysis on the relevant products was initiated, the analysis will be completed; if the laboratory analysis has not yet been initiated, the analysis process will be suspended.

– Upon the payment of the scientific analysis and assessment fees, the licensing process will resume as of the date notified by the TİTCK.

– Priority or high priority applications will be fast-tracked for the active licensing process (the “Active Process List”) upon the payment of the scientific analysis and assessment fees.

– The products listed on the Process Waiting List will be transferred to the Active Process List in accordance with the number of licensed products that were on the Active Process List and the licensing schedule. Applications transferred to the Active Process List will be announced within the first five working days of each month until November 30, 2017.

• For applications initially submitted to and approved by the Preliminary Assessment Department by February 17, 2017:

– Priority or high priority applications will be placed immediately on the Active Process List.

– Other applications will be placed on the Active Process List only upon the payment of the scientific analysis and assessment fees.

• For applications made after February 17, 2017, which are approved during the preliminary assessment:

– Priority or high priority applications will be placed on the Active Process List upon the payment of the scientific analysis and assessment fees.

– The TİTCK will notify the applicant of the active process commencement date and the deadline for the payment of the scientific analysis and assessment fees. Such applications will be waitlisted until the commencement of the active process.

The final waitlist and licensing process for 2018 will be announced in the December 2017 evaluation.

Conclusion

The TİTCK continues to provide pharmaceutical companies detailed guidelines on the medicine licensing process. Pharmaceutical companies should take note of the new procedural steps for their license applications and should follow future announcements made by the TİTCK.