CRED NPM

05/11/2024

Risk minimisation and educational measures

Checklists

•

➢ Should be based on the SmPC

➢ Include questions relevant to SmPC

➢ Include key ‘red flags’ in relation to the product

The Organisation for Professionals in Regulatory Affairs

25

Risk minimisation and educational measures

Training

•

➢ Pharmacy training / educational materials

➢ 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

The Organisation for Professionals in Regulatory Affairs

26

13