Medical products

Draft amendments to the Requirements for the Medication Guide and Summary of Product Characteristics of Medicinal Products for Human Use

The draft Decision provides for updating the text of the Requirements for the Medication Guide and Summary of Product Characteristics of Medicinal Products for Human Use taking into account the low enforcement practice of the Requirements concerning:

- optimization of user's testing of the medication guide of medicinal products for human use,

- updating templates for filling out the medication guide and summary of product characteristics of medicinal products for human use.