- Public Assessment Report (PAR)
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A 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