S.L. 458.57 Art. 3Inspection.

(1) The Authority shall have a right to inspect the premises, records, documents and pharmacovigilance system master files of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX of Directive 2001/83/EC.

(2) After every inspection, the Authority shall report on whether the inspected entity complies with the requirements laid down in Title IX of Directive 2001/83/EC. The Authority shall communicate the content of the report to the inspected entity. Before adopting the report, the Authority shall give the inspected entity concerned the opportunity to submit comments.

(3) If the outcome of the inspection is that the marketing authorisation holder does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file and with Title IX of Directive 2001/83/EC, then the Authority shall also inform other EU Member States, the European Medicines Agency and the European Commission with that outcome.