EMA: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure

Companies developing human medicines that are not delivered directly to patients or where there are availability issues may be exempt from some of the obligations for labelling or package leaflets. These include medicines that are authorised but not marketed and medicines that are being marketed but are temporarily out of stock. The new pharmacovigilance legislation introduced these changes by expanding the scope of Article 63(3) of Directive 2001/83/EC.