Meet EU Safety Feature Deadline Or Face Penalties, Firms Warned
Pharma firms, distributors and pharmacies have been warned that they need to take action to ensure they are ready for the implementation of Europe's product verification system in February 2019. Brexit, though, has cast uncertainty over the extent of the UK's participation in the new system.
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The MHRA has set out its position on those aspects of the new “safety feature” rules for prescription drugs where member states have flexibility to choose their options, such as the information to be included in the “unique identifier” and the conditions for “checking out” medicines from the verification system. The European Medicines Verification System is being introduced as part of the EU Falsified Medicines Directive.
Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.
A freestanding UK Medicines and Healthcare products Regulatory Agency with a dedicated authorization route for new drugs OKd by the European Medicines Agency and national incentives for pediatric and orphan drug development are just some of the likely outcomes of a no-deal Brexit as described in a consultation document just released by the government. In many cases companies will end up paying again for services they currently receive from the EMA, and, the government says, they may pass these extra costs onto the national health service in the form of higher prices.