Serialization: impact of FMD on CMOs
February 7, 2019
The legislation and the European organization model require CMOs (Contract Manufacturing Organizations) great versatility in the implementation of FMD (Falsidied Medicine Directive).
1. The responsibility of the connection to the European Hub is always of the AIC Holder;
2. For companies without a head-quarter in Europe, the connection contract to the European Hub must be signed by the national AIC Holder, who is responsible for it;
3. The connection contract to the European Hub must be signed by the European head-quarter, for the national AIC holders with a European OBP;
4. In the case of multiple social reasons existing in Europe for a given company, it will be only and exclusively the European head-quarter to connect;
5. In the case of AIC holders with multiple CMOs, the latter will not have direct access to the Hub European: they will have to send the data to the AIC Holder who in turn will upload it to the system of European archives.
The CMO can send serialization data, subject to agreement with its client / Owner of the AIC to the European hub through a gateway provider, which in turn will take charge of the upload to the EU Hub. In any case, the direct flow of serialization data from the CMO to the European Hub is never allowed.
Connection option for CMOs
The legal responsibility is exclusively of the owner of AIC. The data can be sent to the European Hub in two different ways:
1. The CMO sends the data to the OBP which in turn posts it on the European Hub
2. The CMO uses an intermediate gateway to send data to the European Hub. The gateway provider must be certified and authenticated by EMVO.
Any gateway provider can be sponsored, registered and certified after an assessement
positive by EMVO.
Some dettails on the gateway provider
■ The Gateway Provider is a third party paid and contracted by an OBP.
■ The Gateway Provider supports, partly or totally, the development, implementation, provision, use and / or operation of the OBP interface to the EU Hub.
■ It is important that EMVO is informed as soon as possible about the type of provider chosen by the OBP.
■ Through the Gateway, the OBP data will be sent to the European Hub.
■ The Gateway Provider must be certified and authenticated by the customer.
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