EU’s Medicines Authentication System Hits Implementation Problems At National Level
The EU’s new medicines verification system, which is due to come into operation in February 2019, is experiencing delays, partly as a result of differences in member state approaches to the implementation of safety features on product packs. The European association representing generic and biosimilar firms has warned that any delays in setting up the system could lead to product shortages.
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Very small companies are to be exempt from the fee for registering with the UK’s verification system that will be part of the future European scheme for checking the authenticity of medicines. Meanwhile, more countries have announced they have connected to the “hub” of the European Medicines Verification System.
Pharmaceutical industry stakeholders are “deeply concerned” about the slow rate of sign-ups to the future European medicines authentication system, according to the industry federation EFPIA. To encourage more companies to connect as early as possible, the joining fee is to increase this month. There are also wider worries about EU member state implementation of the system.
The European Commission's updated guidance on the unique identifiers that are required under the Falsified Medicines Directive contains new information on several areas. It clarifies that the “decommissioned status” of an exported medicine that is brought back into the EU from a third country cannot be reversed and that such medicines should be fitted with a fresh identifier.