Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (c. 83)

[F1 TITLE IX U.K. PHARMACOVIGILANCE

CHAPTER 3 U.K. Recording, reporting and assessment of pharmacovigilance data

Section 2 U.K. Periodic safety update reports

Article 107f U.K.

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.]

Textual Amendments

F1 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).