MHRA publishes new Enforcement Strategy

A new enforcement strategy has been published by the Inspection, Enforcement and Standards Division of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).

The document sets out the MHRA strategy for the enforcement of medicines and medical devices legislation. The Enforcement Strategy is published as part of the UK Government's better regulation initiatives. It sets out our enforcement powers and the way in which they will be applied. Regulators have to demonstrate that they will act in a consistent, proportionate and transparent way.

As part of the strategy, the MHRA is also actively considering extending its existing toolkit of sanctions, which found that the range of sanctions available to regulators was too limited and predicated on criminal prosecution.

The strategy will not change the way in which inspections are conducted, it sets out the different options open to the MHRA when dealing with issues of non-compliance.

The MHRA will always strive to achieve compliance without resorting to Enforcement activity wherever possible, it is only in the most serious or persistent cases that they take enforcement action.

Sanctions imposed by the MHRA can include:

  • Warning letter / notice
  • Caution
  • Criminal Prosecution and asset confiscation
  • Civil Action (Injunction)

The MHRA also has powers to suspend, revoke and vary licences. At present the MHRA has no power to impose administrative sanctions. New sanctions are listed in Appendix B of the document and include monetary administrative penalties, (fixed or variable), statutory notices and enforceable undertakings. The MHRA is currently exploring options to consult on the proposed use of sanctions in more detail.

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