8. Post-Approval

Throughout the life of a medicine, the marketing authorisation holder (MAH) is responsible for the product and to take appropriate action on any information which might influence the evaluation of the benefits and risks of the medicinal product concerned. 

The MAH is required:

• to continuously update the dossier to take account of technical and scientific progress and to introduce any change that may be required for the manufacture and control of the medicine.
• to ensure that the product information (SmPC, labelling, PL) is kept up to date with the current scientific knowledge.

Updating should be taken up through the variation procedure, and be reflected in the dossier and/or Overall Summaries and Overviews, as appropriate.

Legal basis: Article 23 of Directive 2001/83/EC: