21 June 2023
In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive.
The CMDh has confirmed that the CMDh Guideline also refers to purely national marketing authorisations.
A few countries have explicitly waived the request of "Mock-ups" to implement the Falsified Medicines Directive - others still request "mock-ups". Those countries requesting "mock-ups" will address this on their national websites including advice on how and when to submit the mock-ups.
The safety features can already be implemented even if the respective variation notifications haven't been completed yet.
In a transitional phase, there will be differences between approved labelling according the existing marketing authorisation (or according to the approved mock-up) and packaging already on the market. From the CMDh's point of view, this won't be considered as a discrepancy.
The clarifications to the original questions and answers reinforce the very flexible, independent and progressively introduced approach to the preparation for the 2D Matrix Code and the authenticity safety.
Finally, the document confirms that everything related to safety features and product packaging will have to be in place on 9th February 2019.
Please also download the complete document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive" for more detailed information.