Our regulatory lawyers have extensive experience advising businesses and individuals regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) on how best to navigate regulatory challenges. 

The MHRA exercises extensive supervisory and enforcement powers.  Successfully navigating its processes requires a careful balance between constructive engagement with the regulator and protecting legal, commercial and personal interests. Our team combines deep regulatory expertise with a clear understanding of how MHRA actions unfold in practice. 

Where appropriate, we work alongside experts (including specialists in GMP, GDP, GLP, GCP and GPcP from Paradigm Shift Consulting) to develop and implement effective strategies to manage risk and to support a coordinated and credible response to regulatory action. 

We provide strategic, practical support at every stage of a regulatory issue - from early compliance concerns to enforcement action and legal challenge. 

Identifying and addressing emerging regulatory difficulties at the earliest possible stage can be critical in preventing or managing escalation. We support clients undertaking conventional compliance activities, such as audits and internal investigations, and then assist with strategy development and engagement planning where potential MHRA involvement is anticipated. 

Early engagement of lawyers, such as when setting up an internal team to manage a possible MHRA investigation, can offer distinct advantages, e.g. by making effective use of the rules and protections afforded by legal professional privilege. 

MHRA inspections can give rise to significant operational, regulatory and legal consequences. Effective management at this stage can be decisive in limiting further action and/or placing yourself in a position to properly resist or challenge subsequent action. We support clients before, during and after inspections, including by:  

• Advising on the exercise of (and response to) actions of inspectors and responding to information requests; 

• Assessing inspection findings and classifications; and 

• Preparing post-inspection written responses and dealing with other consequential actions. 

In addition to conventional sanctions and enforcement actions, the MHRA may seek injunctions from the civil courts (e.g. restraining the actions of businesses and/or key individuals), and this type of application is something our team is very experienced in responding to and/or seeking the disposal of. 

Where issues are escalated to the Compliance Management Team (CMT), early legal support is essential. Our services include, amongst other things: 

• Advising on the scope and legality of CMT action; 

• Supporting engagement with the CMT to resolve issues without formal enforcement; and 

• Advising on proposed voluntary or other corrective measures. 

Where critical issues are said to have been identified, and a referral is made to the IAG, our team can provide advice and representation in respect of such actions, including: 

• Assisting Licence Holders with appeals against proposed suspensions, variations or revocations, including by way of written submissions or a Person Appointed Hearing. 

• Managing the commercial and supply-chain implications of licensing action. 

The MHRA’s CEU has extensive investigative powers, including search, seizure and interview under caution. Our team can provide businesses and their key personnel with advice and support in connection with the use of those powers and other consequential action, such as criminal prosecution by the Crown Prosecution Service. We work closely with specialist criminal practitioners to ensure seamless support where matters develop into criminal proceedings. 

Our team are experienced in advising on challenges to public body decisions through judicial review. Whilst court action is an ultimate recourse, the underlying public law principles apply throughout all stages of the MHRA’s dealings with the businesses and individuals it regulates. Our team are experienced in ensuring that such principles, which concern unreasonable, unfair or otherwise unlawful decisions, are applied throughout regulatory action, not just at the final stages of enforcement. Early consideration of public law issues  frequently strengthens the position of a business or individual the subject of regulatory action. 

Some decisions of the MHRA are subject to alternative dispute resolution procedures. Our team has a wealth of knowledge and experience in such procedures, including in arbitration. 

Regulatory difficulties rarely (if ever) exist in isolation. Our lawyers collaborate seamlessly across disciplines, to ensure clients receive comprehensive and effective support addressing related issues, such as: 

• Commercial disputes, with suppliers, distributors and customers; 

• Product liability and contractual claims; 

• Directors’ duties and personal exposure issues; and 

• Reputational management and communications strategy.