With the announcement of the MMDA on April 3, 2020, many measures were taken in our country to prevent the spread of the COVID-19 epidemic, which is defined as a pandemic by the World Health Organization. Due to the risk that will occur during the face-to-face readability tests within the scope of these measures with regards to human medicinal products for which a marketing authorisation application is to be made and/or the MA process is
in progress, the readability tests that must be submitted in order to complete the MA procedures can be submitted before the sales permit application until a second announcement, in order to prevent delays in the licensing processes.
With the announcement of the Agency on December 31, 2021, the application date was extended until March 31, 2022. Application acceptance, MA and sales permit approval processes will be carried out on the condition that a commitment stating that the readability tests is submitted to the Authority by the specified date is submitted.
You can access the announcement from the link below.
https://lnkd.in/eYf-pqha