brexit

The changes to the pharmaceutical industry and regulative bodies as a result of Brexit will no doubt significantly alter the way both drugs are marketed and regulated in the United Kingdom. Here at PharmaSciMed, when it comes to matters such as Brexit we try not to speculate, but instead inform and educate.

Regulatory Processes

Late last year the British government called on pharmaceutical companies and medical device manufacturers to ensure that patients are able to access their medications after Brexit. There really isn’t much to say on this quite yet, as pharma companies working with Whitehall have signed around 26 non-disclosure agreements in the case of a no-deal Brexit.

Relocating the European Medicines Agency

Probably the most notable impact from all the information available is the relocation of the European Medicines Agency (EMA) from London to Amsterdam. The EU agency is tasked with regulating pharmaceutical and veterinary medications as well as medical devices. In August last year, the EMA openly stated that it would lose around 30% of its workforce and temporarily stop its non-core components. The final and full effect of the relocation of the EMA on the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is not known either.

Medicines and Clinical Trials

August last year saw the MHRA write guidance on the EU’s new Clinical Trial Regulation (CTR) which stated: “If the new regulation does not come into force during the implementation period, the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.”

Based on the assumption that the U.K. becomes a ‘third country’ , sponsors wishing to import supplies from this ‘third country’ require a qualified person ‘permanently and continuously at his disposal’ in the EU to ensure that the medication was produced with good manufacturing practices.

Falsified Medicines Directive (FMD) Packaging

According to the MHRA: “The UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations.
“When the UK exits the EU, the Withdrawal Act will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the FMD would continue to apply, unless specifically revoked.”