Track & Trace: EMVO stakeholders call for inspections

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

Seven months into the operational phase of the EU Verification System a significant number of manufacturers and supply chain actors have not yet connected to the system. Data provided by the European Medicines Verification Organisation (EMVO) estimate that 40% of (theoretical) manufacturers as well as 25% of other supply chain actors (e.g. pharmacies, hospitals, wholesalers, dispensing doctors) have not yet connected to the medicines verification system. However, in terms of volume, some medicines are manufactured less than once a year, and, in the cases those have not been manufactured after February 2019, their codes are consequently not in the system.

Still fighting with false alerts

The Industry is still fighting with false alerts and most of the member states are still in stabilization phases. The EMVO report says that approximatively 3% of all scans undertaken by supply chain actors lead to false alerts being generated due to various reasons (see also Track & Trace: Still ongoing issues), such as:

• 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.

Therefore, the EMVO stakeholders encourage National Competent Authorities (NCA) to start enforcing the primary requirements of the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161 and undertake on-site inspections on all supply chain actors. According to the EMVO, the demanded NCA-inspections should focus on the following:

• Full IT stabilization of the systems,
• Supply chain actors who are not connected to or do not use the system at all,
• End-user IT software providers,
• Manufacturers connected but not uploading data,
• End-users connected but without configuring scanners, establishing procedures and / or proper training for staff,
• End-users connected but not scanning serialized packs.

More information can be found on the EMVO website in EMVO stakeholders’ considerations on enforcement and inspections.