Abstract: The Turkish Medicines and Medical Devices Agency published a new Guidelines for Off-Label Use of Drugs on February 8, 2019.
The Turkish Medicines and Medical Devices Agency ("Agency") published a new Guidelines for Off-Label Use of Drugs ("Guidelines") on February 8, 2019 and abrogated the Guidelines for Off-Label Use of Drugs dated July 18, 2014. The Guideline is in force as of February 8, 2019.
The published Guidelines references a new system for the applications for off-label use of drugs. The system is named as the "System on Administration of Unauthorized and Off-Label Drugs" (in short in Turkish "REIYS"). Pursuant to Article 4/6 of the Guidelines the applications for off-label use of drugs shall be made via the REIYS online or via post to the address of the Agency.
The Guidelines did not change the provision regarding for retrospective application. In case where the off-label use of a drug has been initiated without the Agency's authorization, the applications made by the physician after such use shall still not be evaluated. However, the Guidelines introduced an exception for the acceptance of such application in cases where it is determined that the drug was used off-label for a medical emergency.
Lastly, the Agency requires new applications for drugs which were already approved for the off-label use before the entry into force of this Guidelines. Therefore, physicians shall apply to the Agency for the authorization of off-label use of drugs which were previously approved.
Source: Guidelines for Off-Label Use of Drugs published in the Turkish Medicines and Medical Devices Agency's official website (Turkish language)
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