CRED NPM

06/11/2024

External Engagement

• Initiated dialogue with key EU Health Authorities to share the revised strategy & OTC model

Health Authority

• Identified RMS and potential CMS markets for a DCP

• Provided assurance that the previous issues could be addressed in those EU markets open and supportive to the benefits of broader access • Initiated extensive HCP engagement with key Pharmacists, Clinicians, Urologists, Sexual Health experts to understand the role OTC Viagra could play in Primary care • Arranged Advisory boards to understand what needed to be true for optimal OTC access → no lengthy pharmacy questionnaires!!

HCPs

The Organisation for Professionals in Regulatory Affairs

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OTC Model: Pharmacy Checklist designed based on “WWHAM” Principle used by UK pharmacists

Male >18yrs

Taking PDE5s already eg via internet, or supplements?

Confirm ED / misuse

• Who is the medicine for? • What are the symptoms? • How long have you had the symptoms? • What Action have you taken? • Are you taking any other Medication ?

Determine where in CV progression pathway individual may be

Assess any Contraindicated medications

Not covered directly by WWHAM:

1. CV health + Fitness for sex 2. Contraindicated conditions 3. Follow up advice for men

The Organisation for Professionals in Regulatory Affairs

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