Thursday, 05 December 2019 15.00 - 16.30 h
In March CMDh published a new Q&A document to provide further guidance on the implementation of the EU Falsified Medicines Directive. The title reads "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".
The answers confirm the very flexible, independent and phased in approach as preparation for the 2D Code and anti-tampering. How to deal with mock-ups and the different approaches in the Member States is discussed in several Q&As.
The document also indicates that the safety features can already be implemented, even if the respective variation application has not been approved. However, requests for variations should be submitted as early as possible.
The document finally confirms that everything related to the safety features on packaging has to be implemented until 9 February 2019
You can find the complete"CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive" here.