Sweden prolonged FMD "soft launch" period

After recommendation from the Swedish Medicines Verification Organisation (e-VIS), Sweden had a ‘soft launch’ for the implementation of Falsified Medicines Directive (FMD). The aim was to give all stakeholders the possibility to gain more experience during the first weeks of the implementation. The "soft launch" period has now been prolonged until 30 September 2019 to be used as a stabilization period.

During the "soft launch" and stabilization period, all 2D-codes in the packing are scanned but certain system alerts, caused by missing or incorrectly uploaded data are not considered as indicative of a potential falsification by pharmacies and in some cases wholesalers.

This does not mean that pharmaceutical companies are exempted from uploading data to the European database, EU Hub. At the moment, some companies still have problems to upload data in the system and many companies have challenges regarding e.g. expiry date mismatch, which is causing warnings and alerts. To ensure a working supply chain, work still needs to be done; all serialized data must be loaded retrospectively, and incorrect data must be corrected.

By verifying spot checks at receipt, Oriola is hoping to help pharmaceutical companies to discover potential errors with their packages so that they can be corrected before entering the market’’, comments Susanne Regestam, Senior Quality Specialist at Oriola Sweden.

In the latest publication from e-VIS, it is requested that all stakeholders take responsibility to ensure that packs with data errors are not passed on further in the distribution chain closer to the patient. When the stabilisation period is to be discontinued, packs causing alerts will not be possible to dispense.

Follow the development and get the latest news regarding the directive by visiting e-VIS website.