As from 9 February 2019, the Falsified Medicines Directive (FMD) will apply. Based on this, the Luxembourg National Medicines Verification Organisation (LMVO) will implement a Luxembourg verification system in cooperation with the Belgian National Medicines Verification Organisation (BeMVO).
As stipulated in the FMD and the related Delegated Regulation, the system and its operations must be financed by the MAHs acting within the Luxembourg scope of the FMD.
Therefore, The LMVO requests:
- A one-off registration fee
- A yearly flat fee, in line with the recommendations of European National Medicines Verification (EMVO), will be invoiced as from February 2019.
The Luxembourg scope of the FMD is defined as follows:
– All products under prescription according to the Luxembourg legislation
– Plus the ‘black list products’ as identified in annex 2 of the Delegated Regulation
– Minus the ‘white list products’ as identified in annex 1 of the Delegated Regulation
– Plus all products defined by the Luxembourg Competent Authorities.
More details can be found here.