4. Package labelling

The text that appears on the label (inner (immediate) and outer packaging) of medicines is regulated in a similar way to the PL. The labelling gives information relevant for the patient as well as members of the distribution chain.

• For the patient, there may be information on special storage conditions, e.g. store in a refrigerator or store protected from light.
• For the pharmacy, there is information to identify the medicine, for example the name and active substance, route of administration etc.
• In addition, batch numbers are important, e.g. in case a batch is recalled by the manufacturer.