All Directors of Edmonds Marshall McMahon have extensive experience in the area of regulatory law, having advised and prosecuted for the Medicines and Healthcare products Regulatory Agency (MHRA), Department for Food, Environment and Rural Affairs (DEFRA), Health and Safety Executive (HSE) and the Environment Agency.
We have also advised pharmaceutical companies and medical device manufacturers on the complex area of the medicines and medical devices licensing regime. The background of our Directors and senior lawyers allows us to give comprehensive, commercial and relevant advice– a combined total of 16 years experience prosecuting on behalf of and providing advice to the Medicines Healthcare products Regulatory Agency (“MHRA”) means there is little we don’t know about this complex regime.
Specific Areas of expertise include:
- Criminal offences arising out of import, export, wholesale dealing, “placing on the market”, transit theft, counterfeiting, unlicensed products and conspiracy to defraud;
- All elements of the licencing regime in relation to pharmaceuticals and medical devices including wholesale dealing, manufacturing and import and export within and outside the UK & EU;
- All aspects of clinical trials such as approval, conduct and litigation.
Our Partners, Andrew Marshall and Tamlyn Edmonds both successfully prosecuted the case of R v Gillespie and others (Op Singapore) (2011), the largest ever prosecution conducted by the MHRA. This case concerned the importation of counterfeit prescription only, life saving medicines which eventually reached the legitimate supply chain within the UK, leading to a rare Class 1 recall by the MHRA. Charges included conspiracy to defraud, Medicines Act offences and Trade Mark offences. Much consideration was given to the ambit of legitimate parallel trading within the EEA and the underlying regulatory regime (drawn from EU Regulation and UK Statute and Regulation).
Because of our experience and expertise in this complex regulatory area, we are able to provide detailed and comprehensive advice on most regulatory areas, whether that be for the regulator or those subject to the regulatory regime. Please contact us for further details.