On the beginning of May we sent a newsletter regarding the draft act on clinical trials of medicinal for human use that implements the Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC ("Regulation").
On 17 January the new version has been published in a public domain ("Draft").
First of all, the Draft is still on an early stage of the legislation process, thus it will not come in force by 31 January 2022, when the Regulation comes in force. The Draft assumes to come in force within 30 days as of the date of its publication.
The most important changes introduced in the current version of the draft regard:
Click here to access the full alert.
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