What If UK Leaves from EU with No-Deal?

Posted by atlsystems on August 28th, 2019

FMD (directive 2011/EU) came into effect from February 2019 By European Union that enforced rules against toxic and false medicine and drugs for patient safety. According to the directive all the medicines need to be purchased and sold only with prescription. There is also inclusion of a unique serial number encoded by 2D barcode and a visible ATD i.e. anti- tempering device. This is to ensure the medicine safety and prevent them from tempering and duplication at each supply chain. The packaging remains intact and reaches as it is without any duplication from manufacturer to supplier and retailer and then to consumers. Since, it is a long process there are chances of tempering the unique ATD and barcode safety ensure there is no threat with the medicine. It also made strict quality check to omit false medicines that may have low or high strength of an active ingredient.

There are specific hardware and software system to monitor the circulation of drugs that are under guidelines. The database is maintained by EU Falsified Medicines Directive and the system is updated if there is any addition of new drug. EU FMD main motive is to ensure patient’s safety and access to safe and true medicine through these steps and guidelines.

UK Brexit can be a game changer for pharma companies and will not be good for patient’s health. Worrying about deal or no deal Brexit some companies have shifted to other manufacturers from other companies. There is also a fear of medical supply shortage after a no-deal Brexit departure. The shape of Britain will be changed after Brexit and it will definitely have strong effect on pharma.            

Pharmacies will have no guidelines and legal obligations from FMD if “no-deal” Brexit.

In case of no-deal agreement, UK will have no access to EU central data hub, therefore the companies will not be able to upload and verify unique ID barcode on the medicine packages.

So, it is obvious that with a no-deal agreement the FMD regulations will no longer be applicable and will be concerning for the patients and medical practitioners. If UK leaves EU without a deal that would be a shortcoming for healthcare.