P2.2 Clinical evaluation (Section 2)

Page last updated: September 2016

Additional Information Request

  • Present trial or study data to support the use of the proposed product in patients (Section 2)

P2.2.1 Trial or study data

As a minimum, provide any available data arising from use of the proposed product in patients. This extends the assessment beyond a comparative review of nutritional content to inform a comparative clinical assessment of effectiveness and safety. Data on use of the proposed product in regular clinical practice may also supplement the trial or study data included in Section 2.

Provide direct randomised trial or other study data in a format consistent with the guidance provided in Section 2.