Registration for each location where a pack of medicines will be validated or marked as supplied is required. This registration as a location will be done with the NMVO (National Medicines Validation Organisation) in order to maintain compliance with the FMD (Falsified Medicines Directive). The definitive voice on this topic is the national organisation in your jurisdiction. Where details are given below, they relate to Ireland and may change as the process is developed up to February 2019.
If we operate at multiple locations, do we need to register each location separately?
Yes, one registration per location is a requirement. It must be possible to identify the location where a pack is verified, supplied, etc. One entity (person, firm, company) can apply for multiple registrations, one per location. (More than one registration in a location may be required, if two legal entities operate from the same location – e.g. a wholesaler and retail pharmacy operating from the same building or a public and private hospital working on the same campus.)
Is a registration key transferable from location to location?
No, you cannot move a PC from one location to another without changing the registration key to reflect the new location of use.
If we want to use multiple scanning PCs in one location, do we need to register each PC separately?
No. In a busy retail or hospital pharmacy or wholesaler, several scanning stations (or PCs) may be required. When they are all working within one legal entity in one location, they can use the same registration key.
Where do I have to register to get a unique key per location?
The NMVO is the place to go. For instance, in Ireland the IMVO will operate the registration or “on-boarding” as they describe it. The application will be made online and the IT provider will help set up the user’s key on their system, it is foreseen. As additional details become available, this question / answer will be updated.
How much will registration cost?
The overall framework is that the FMD system is funded by the MA holders and therefore no direct costs will arise with registration. It is possible that some NMVO’s will introduce a modest administration charge – please contact your local NMVO for any cost details. Any such costs would reflect the exception rather than the rule.
Do users have to sign individually into ezFMD before they can use it?
This is a local administraor option, depending on the needs of the location:
- Access to the system with the location’s key installed should be restricted to persons trained in its use. Given the high frequency where scans are conducted among a team of workers, a regular login and logout is not considered practical in the foreseen workflow in most locations.
- ezFMD does incorporate a feature of individual (per-person) sign-in for locations which consider this useful to them. It may be particularly useful in locations which wish to limit the options an indivudual person may access, such as Verify only. See full details here.