Public Assessment Report (PAR)

public assessment report is published by the MHRA if you receive a positive EAMS scientific opinion.

The Public Assessment Report will include:

  • how the product is used and how it works
  • summary of the key clinical studies
  • the risks and benefits of the product
  • the reason for the positive EAMS scientific opinion
  • any uncertainties
  • information about ongoing clinical studies
  • measures in place to monitor and manage risk

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