FTM Serialization Solution for Marketing Authorization Holders to comply with EU Falsified Medicines Directive (FMD)
EU Marketing Authorization Holders are from Feb. 9th required to comply with EU Falsified Medicines Directive (FMD) 2011/62/EU. There are several requirements introduced by the directive, most of the responsibilities are on MAHs. In nut-shell MAHs are responsible for:
1. Mark each package of pharmaceutical product with a unique identifier
2. Introducing safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product.
While the second point is not too complicating and can be handled by CMO, the first point is trickier.
In fact on MAHs shoulders lies responsibility for generating unique identifiers (serial numbers – SNs), print them on packages or send them to CMO, report used numbers to EMVO (European Hub).
There are several track and trace solutions out on the market providing required features however on top of that they provide bunch of other features which are of no interest for MAHs without own production (working through CMOs). The price of such solutions corresponds with system robustness, simply said it is very expensive.
And that is where we start. Similarly as with another our product eCTD Submission Manager we have decided to develop a least valuable product. In other words our system will do just as much as is needed to comply with EU Falsified Medicines Directive, nothing more. Because of that the price of our solution is far more suitable.
What exactly will FTM Serialization Manager provide me?
As stated above, you will get all you need to comply with EU Falsified Medicines Directive, nothing more. In general following main use cases will be fulfilled.
1. Accepting and processing SNs generation requests
2. Generating SNs and responding to SNs generation request
3. Importing and processing product production event
4. Reporting SNs to EMVO
Why should I purchase your solution?
• Very simple installation, you do not need to spend months with initial configuration.
• Simple to use for operators
• No installation requirements
• Up to date with legislation with regular updates
• Maintenance and support
What companies is FTM Serialization Manager intended for?
Well, because of what was said above, we are targeting to small/midsize companies without own production working with CMOs. There are no limits to serial number volumes however there are functionality limits. For example our solution is not able to control a production line.