For products in Phase 3 research, when do you recommend getting ready for serialization for Falsified Medicines Directive? A: It is worth having the conversation with your CMO early. Work backwards from planned launch date by at least a year to be safe. Below what level of annual turnover do you think that corporations will not engage in this process and drop their Rx-bound activity? A: We have seen some very small companies contemplate that step.
Below about 50, annual units produced, it is hard to amortize costs β except for high value products. A: The rfxcel track and trace software automatically manages the issuing, reconciliation etc. A: Yes. Until product data is uploaded to European Medicines Verification System EMVO which must be at or before QP release of the product any data manipulations are fine as long as they are tracked and auditable. Is there any penalty foreseen in case a corporation or country is not ready on time?
For corporations, it is simple. No codes, no sales. A: The countries of the EU are at different states of readiness. Some NMVOs are running pilots and getting people connected, others are not yet fully set up.
A: In the case of rfxcel, both are possible. Typically, it would be between Level 4 systems. A: Can be anyone but should be the person able to answer and deal with queries etc. Is this is the same as the SPOC? A: Varies by company. Someone must sign as a legal designate of the corporate entity i. Do you have one example in national legislation of stated requirements? The immediate timing of the FMD will be before Brexit, and with the month transition time that is built in, this will allow the UK to carry on with any rules which are to be enforced during that period.
The UK is such a large manufacturing country; I would be astonished if they diverge away from the rules that apply to the rest of the EU Union. A: No one knows the true answer to that. However, it could be quite possible if we are nearing the deadline and a sufficient number of organizations are not ready. With that said, I would not want to be the guy who has to explain to his superiors that we chose not to prepare ourselves, as we were counting on a delay that did not occur.
