CRED NPM

05/11/2024

Risk minimisation and educational measures

Condition being treated

Pharmacy training / educational materials

•

Product being sold

➢ The SmPC should form the basis of the materials ➢ Materials should be proportionate to the training required and not be promotional or an unnecessary burden

Key safety risks

Examples of when the product can and can’t be sold

Case studies

The Organisation for Professionals in Regulatory Affairs

27

Risk minimisation and educational measures

Consumer education

•

➢ This is especially important to think about if it is a new OTC category

The Organisation for Professionals in Regulatory Affairs

28

14