CRED NPM

05/11/2024

Supply

Consideration should be given to the proposed supply model

• Will interactions with pharmacists be required?

• What is the consumer journey?

The Organisation for Professionals in Regulatory Affairs

13

Efficacy

During the reclassification process efficacy does not need to be specifically addressed unless there is a big change in indication, dosage regimen or patient population compared to the reference licence

➢ If that is the case, proof may be needed that the product is effective for those particular circumstances

The Organisation for Professionals in Regulatory Affairs

14

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