40% of Manufacturers Fail to Connect to EU Medicines Verification System

Regulatory NewsRegulatory News | 22 July 2019 |  By 

The nonprofit European Medicines Verification Organisation (EMVO) warns that five months into the operation of the European Medicines Verification System, which is meant to protect against falsified medicines and supply chain disruptions, a significant number of manufacturers and supply chain actors have not yet connected to the tracking system.

“Current available data from EMVO/NMVOs [National Medicines Verification Organisations] estimate that two fifths (40%) of manufacturers as well as one quarter (25%) of other supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have not yet connected to the medicines verification system(s),” EMVO said in a July report.

The nonprofit is now calling on National Competent Authorities (NCAs) to start enforcing the primary requirements of the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161 and inspect all supply chain actors.

“Both EMVO and NMVOs stand ready to supply all necessary and available information to National Competent Authorities,” EMVO said. “The system can only fully work as intended if all actors are connected to it.”

To help NCAs, NMVOs can provide information on which end users have not yet connected, which end-user IT software providers have not yet upgraded their system to comply with the coding and decoding rules of the new system, which end-users are connecting but are not scanning serialized packs and which manufacturers are releasing serialized medicines in their market without uploading the corresponding data into the respective National Medicines Verification Systems.

A high level of false alerts within the verification system also is raising questions for EMVO, which said the alerts are mostly related to “missing data upload into the European Hub, incorrect data upload, incorrect scanner configuration of end-users, pharmacy/hospital software systems not updated, procedural reasons, system not used properly etc.”

If serialized drugs are released on the market without uploading the corresponding data into the verification system(s), false alerts can be triggered for each drug, EMVO explained.

“EMVO stakeholders consider that they can only credibly create an environment where National Competent Authorities can declare an end of the ‘stabilization periods’ if the number of ‘false’ alerts is significantly decreased (at least 100-fold reduction),” EMVO said. “Until this point is reached, products which are triggering ‘false’ alerts should still be dispensed to the patient and not be returned upstream in the supply chain, since the causes of these ‘false’ alerts are multifactorial. With a ‘false’ alert rate of 3%, this might lead to up to 2,000 products being in short supply. In the interest of continuous supply to patients, EMVO stakeholders suggest allowing end users to dispense products which trigger ‘false’ alerts until the overall alert level has stabilized below 0,05%.”

Supply chain security expert Dirk Rodgers told Focus: "I don’t know why some manufacturers have not complied yet. It could be like the attitude of the local industry in India and Russia when those countries announced aggressive deadlines [for their track and trace systems]. The international manufacturers treated them seriously, even though they had to 'break their necks' trying to get ready by those deadlines, but the local guys just laughed it off and ignored them. And, of course, at least in India, they were right. We don’t know yet if Russia will keep their deadlines."

He also said he thought the “100-fold” improvement "is a good target. "That will require big penalties for non-compliance. It will be interesting to see if they do something like that, especially before they get those management functions."

Meanwhile, EMVO also said last week that it intends to "propagate all alerts received from the National Systems to OBPs [onboarding partners]."

EMVO stakeholders’ consideration on enforcement and inspections under the Falsified Medicines Directive 2011/62/EU (FMD) and its Delegated Regulation EU 2016/161 (DR)


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy