1. Introduction

Introduction

Many people suffering from an illness go to their doctor and ask for advice. In most cases, a patient will expect a treatment. In many cases, the doctor will prescribe a medicine.

It is important that both, the doctor as well as the patient, have access to the information about available medicines which allows the doctor to choose the right medicine, find correct and detailed information on all characteristics of a medicine, especially benefits and risks for explanation to the patient, and the patient to find all information for appropriate and safe use of the medicine.


The European Union (EU) legislation contains detailed provisions on medicines information. Directive 2001/83EC and Council regulation (EC) 726/2004 set out the requirements for the different types and levels of information to be provided:

  • Summary of Product Characteristics (SmPC): provides detailed information on the medicine for healthcare professionals on specific characteristics of each medicine.
  • Package Leaflet (PL): is primarily intended to summarise information on the medicine for patients. It is also contained within each pack of the medicine.
  • Labelling on immediate or outer packaging[1].
  • European Public Assessment Report (EPAR) including the reports on initial evaluation and major variations. (for centrally authorised medicinal products)
  • 'EPAR summaries for the public' (now designated ‘public-friendly overviews’):  a short non-technical version of the full EPARs in lay language.
  • Public assessment report (PAR) for medicines approved in the Member States of the European Union according to the Mutual Recognition or Decentralised Procedure (similar to the EPAR).

There are high-level requirements in the legislation and more detailed information in guidelines from the EMA or Heads of Medicines Agencies (HMA) on how to prepare SmPC, Labelling and PL. For SmPC and PL the content and the order in which the information should be provided is set by legal mandate, for Labelling the content. All information on the medicine is stored on the EMA website for centrally authorised products (CAP) and is also available for products authorised through other procedures on the National Competent Authorities’ (NCAs) websites in most of the member states (MS). Information is available for health care professionals, patients and the public.



[1] DIRECTIVE 2001/83/EC Title1, Definitions: Labelling: Information on the immediate or outer packaging. Immediate packaging: The container or other form of packaging immediately in contact with the medicinal product. Outer packaging: The packaging into which the immediate packaging is placed.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0083-20190726&from=EN