CRED NPM

06/11/2024

New DCP Application was Submitted with UK as RMS

• Created new MAA for 50mg OTC including new:

• Product Information

• Risk Management plan

• Clinical Overview (including the switch rationale)

• Meta analysis of 50mg efficacy

• Pharmacy education program

The Organisation for Professionals in Regulatory Affairs

31

The UK approved Switch to Pharmacy status in 2017, with Norway and Ireland following in 2018 and 2020,respectively.

The Organisation for Professionals in Regulatory Affairs

32

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