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TMMDA PUBLISHED A GUIDELINE ON THE MANAGEMENT OF CRISES AND EMERGENCIES



Turkish Medicines and Medical Devices Agency (“TMMDA”) published the “Guideline on Management of Crises and Emergencies Where Routine Regulatory Processes Cannot Be Followed for Medicinal Products for Human Use” (“the Guideline”) on 7 September 2022.


The purpose of the Guideline is stated as the determination of flexibilities that may be applied in terms of the TMMDA's regulatory duties in order to ensure safe drug access to the public during crises or emergencies.


In this regard, the Guideline covers the topics such as conditional licensing, GMP certificates, inspections, readability tests, online meetings of Scientific Advisory Commissions, the status of apostilled or consulate-approved documents. conditional licensing, GMP certificates, inspections, readability tests, online meetings of Scientific Advisory Commissions, and the status of apostilled or consulate-approved documents.


You can access the Guideline from the link below (in Turkish):

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