A new enforcement strategy has today been published by the Inspection, Enforcement and Standards Division of the MHRA.
The document sets out the MHRA strategy for the enforcement of medicines and medical devices legislation. It reflects Government Better Regulation initiatives, as well as the recommendations contained in the Hampton Review (external link), and the Regulators’ Compliance Code (external link), which set out the principles and characteristics to be applied in the enforcement of regulations.
As part of the strategy, the MHRA is also actively considering extending its existing toolkit of sanctions, based on the recommendations of the Macrory Review, which found that the range of sanctions available to regulators was too limited and predicated on criminal prosecution.
The MHRA works with its stakeholders to ensure a high level of compliance, however, in a minority of cases the MHRA will take action against those who fail to comply with the recognised standards or seek to operate outside of the licensed and regulated regime.