The eMC contains two types of documents. 

  • Summaries of Product Characteristics (known as SPCs)
  • Patient Information Leaflets (known as PILs, Package Leaflets or PLs)

Summaries of Product Characteristics

An SmPC tells healthcare professionals, such as doctors, pharmacists and nurses, how to prescribe and use a medicine correctly. An SmPC is based on clinical trials that a pharmaceutical company has carried out, and gives information about dose, use and possible side effects. An SmPC is always written in a standard format, which is explained in our glossary.

Patient Information Leaflets

A PIL is the leaflet that is included in the pack with a medicine. The PIL is a summary of the SmPC and is written for patients. Our glossary section explains more.