Home
Regulatory Affairs Services
All medicinal products which are placed on the market are required by the law to be accompanied by labelling and package leaflet which provide a set of comprehensible information enabling the Patient to use the medicinal product safely and appropriately.
In accordance with Article 59(3) of Directive 2001/83/EC, the package leaflet shall reflect the results of consultations with target Patient groups to ensure that it is legible, clear and easy to use.
