EMA: Union procedure on sharing of pharmacovigilance inspection information

Article 111(1) of Directive 2001/83/EC states that the competent authority of the Member State concerned shall ensure that the legal requirements governing medicinal products are complied with, by means of inspections, in cooperation with the European Medicines Agency (hereinafter \'the Agency\'). The Directive clearly defines that this cooperation shall consist of sharing information with the Agency for both inspections that are planned and those that have been conducted. Member States and the Agency are also required to cooperate in the coordination of inspections in third countries.