Medicinal Product Labelling: What You Need To Know

Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label have in common?  They all aim to provide us with information about the associated product.

Medicinal products are no exception and must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet providing information enabling the safe and effective use of the medicinal product. In fact, medicinal products are legally required to have certain information on the labels and package leaflets as defined in Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended).

The outer and/or immediate packaging must include information such as:

  • the name of the medicinal product
  • its strength and pharmaceutical form
  • a statement of the active substance(s)
  • and the method of administration

The summary of the product characteristics (SmPC) sets out the position of the medicinal product as agreed during the assessment process. This is the basis of information for healthcare professionals on how to use the product safely and effectively. The package leaflet is drawn up in accordance with the SmPC, but is written in patient friendly language and therefore plays an important part in the safe and effective use of the medicine by the patient.

How easy is the package leaflet to read?

User consultations are required to demonstrate the readability and usefulness of the package leaflet to patients. One of the possible ways of complying with this is by performing ‘user testing’. This means testing the readability of a package leaflet with a group of selected test subjects to identify whether or not the information as presented, conveys the correct messages to those who read it.

In accordance with European legislation, the Marketing Authorisation Holder (MAH) must also place the name of the medicinal product in braille format on the outer packaging of medicinal products and must ensure that the package leaflet is made available in formats appropriate for the blind and partially sighted.

In addition to the HPRA Guide to Labels and Leaflets of Human Medicines, European guidance documents on medicinal product labelling and package leaflet also include;

  • The European Medicines Agency‘s Working Group on Quality Review of Documents (QRD) templates for the product information for human medicines.
  • Guideline on the readability of the label and package leaflet for medicinal products for human use.
  • Guideline on excipients in the label and package leaflet of medicinal products for human use.



Medicinal product labelling and the package leaflet provides the patient with important information about their medicine to allow the safe and effective use of the product, whether it be an over the counter medicine or one prescribed by the doctor.

If you would like to discuss this issue further with us, then please call us on 00353 52 61 76706 or complete your details below.

More About Labelling

Advice On Supporting Module 1.3.4 Of A Medicinal Product Application

In this article, Senior Regulatory Affairs Advisor, Eileen Shortiss, gives advice on supporting Module 1.3.4  of a medicinal product application.  This is the latest article in a series written by Eileen that looks at issues relating to labelling, leaflets and SmPC’s.  Read the full article here.

Package Information Leaflets: An Overview

We have a team dedicated to the creation and testing of package information leaflets.  Members of our team have written extensively on this website and in other industry publications about the issues associated with package information leaflets and much more.  Here, we have highlighted just five articles that our team members have written on the subject in recent times. Read the full article here.

And finally….is it ‘labeling’ or ‘labelling’?  The website Grammarly says:  “Labeled and labelled are both correct spellings, and they mean the same thing. If you are writing for American readers, labeled is the preferred spelling. In other places, such as Great Britain and Canada, labelled is a more common spelling than labeled”.

Further Reading from Acorn Regulatory

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)

Read the article here.

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read the full article here.

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

How To Prepare For A Pharmacovigilance Inspection

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared.  Read the full article here.

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

  • common deficiencies
  • common validation issues
  • the challenges posed by the eAF
  • what to do when documentation is missing
  • how to handle GMP variations
  • what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.



About the Author
Eileen Shortiss
Senior Regulatory Affairs Advisor - Pharmacovigilance
Eileen Shortiss joined Acorn Regulatory in 2006. During her time with Acorn Regulatory, Eileen has worked on a vast array of projects for clients all over the world. Eileen is extensively involved with pharmacovigilance KPIs and driving continuous improvement measures across the department. Furthermore, she has considerable expertise and experience in the area of patient information leaflets. You can read other articles by Eileen Shortiss by clicking the link below.
Other articles by Eileen Shortiss