Regulatory, Compliance & Legal
We are able to assist with regulatory, compliance and legal issues, particularly involving FMCG, healthcare and the pharmaceutical sectors. We have experience in dealing with the Medicines and Healthcare products Regulatory Agency (MHRA), including the Inspection Action Group (IAG), NHS (including CCG), General Pharmaceutical Council (GPhC), General Medical Council (GMC) and other regulatory authorities and agencies.
We have advised and represented on a great number of regulatory, compliance and legal issues within the healthcare and pharmaceutical sectors, particularly those issues including the MHRA, GPhC and GMC.
Our recent regulatory, compliance and legal experience
Our team have recent relevant experience in a number of areas, including in:
- Advising and representing various holders of an MHRA WDA(H) with referrals to the Inspection Action Group IAG for compliance deficiencies arising out of the Human Medicines Regulations 2012 and the principles of EU Good Distribution Practice (GDP) including those licence holders facing proposed (and immediate) suspension and removal of the Responsible Person and other variations by the MHRA (via IAG).
- Advising in relation to a claim against the NHS (including CCG) in relation to its decision to refuse to pay a pharmacy for its claims.
- Advising a pharmacist in connection with an enquiry by NHS England.
- Assisting pharmaceutical wholesalers in connection with regulatory enquiries by the MHRA, leading to no further action being taken both in respect of the regulatory matter (arising out of EU GDP and the Human Medicine Regulations) and the criminal enquiry (arising out of the Misuse of Drugs Act and Misuse of Drugs Regulations).
- Provided representation to a wholesaler in connection with an enquiry by the MHRA relating to the dealing in high-value medicines, following a referral to the Inspection Action Group (IAG) as a result of serious deficiencies in respect of the Human Medicines Regulations 2012 and Good Distribution Practice (EU GDP).
- Advising a director in respect of enquiries by the NHS Counter Fraud Authority.
- Advising a WDA(H) holder (wholesaler of pharmaceutical products and medicines) in respect of exposure under the Misuse of Drugs Act, Misuse of Drugs Regulations, The Human Medicines Regulations 2012 and GDP in respect of deficiencies identified by MHRA subsequently referred to IAG for consideration of suspension.
- Advising regulated professionals with simultaneous regulatory and professional practice action including with the General Pharmaceutical Council and General Medical Council, including those arising out of pharmaceutical wholesaling.
- Assisting a pharmacist the subject of an investigation by the GPhC, leading to the case being closed by the GPhC with no further action being taken at the pharmacist.
- Advising a regulated professional in connection with regulatory and professional enquiries relating to its dealings in high-value products across Europe, leading to a discontinued investigation after representations
- Advising a former wholesaler (regulated by the MHRA) in connection with its legal and compliance obligations under the Human Medicines Regulations 2012 and providing advice on how to comply with a request by a regulatory agency, leading to no further action being taken.
- Advising a large company in relation to its legal and compliance obligations in respect of money laundering and counter terrorist financing, leading to a successful inspection by the supervisory authority.
- Advised businesses on risk-based due diligence investigations for large FMCG and retailer firms across Europe on their business partners, to assist client firms in managing their risk exposure across their businesses
- Investigated complex pan-European missing trader and VAT fraud to identify Defendants who would be subject to civil proceedings to recover funds that have been dishonestly obtained for the benefit of the client firm
- Advised a large London construction firm in relation to a procurement dispute with a large London local authority, successfully resulting in the authority re-tendering for works.
Telephone: 0203 397 8958
E-mail: [email protected]