TITLE IX

PHARMACOVIGILANCE
CHAPTER 3

Recording, reporting and assessment of pharmacovigilance data
Section 2

Periodic safety update reports
Article 107f
Following the assessment of periodic safety update reports, the national competent authorities shall consider whether any action concerning the marketing authorisation for the medicinal product concerned is necessary.
They shall maintain, vary, suspend or revoke the marketing authorisation as appropriate.
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).