TITLE IX

PHARMACOVIGILANCE
CHAPTER 3

Recording, reporting and assessment of pharmacovigilance data
Section 2

Periodic safety update reports
Article 107d
The national competent authorities shall assess periodic safety update reports to determine whether there are new risks or whether risks have changed or whether there are changes to the risk-benefit balance of medicinal products.
Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).