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.

You can find the links to the other articles in the series below.

Submitted as part of the application for a medicinal product to a regulatory authority, the summary of product characteristics (SmPC) sets out the agreed position of the product and is the basis of information for healthcare professionals on how to use the product safely and effectively. The package leaflet is based on the SmPC and provides information on using the medicine safely to users such as patients and carers. The package leaflet text also needs to be formatted into a mock-up of the sales presentation (consideration being given to font type and size, design, layout and writing style) and along with the SmPC and package leaflet this forms part of Module 1.3 of the Common Technical Dossier (CTD).

Advice on Supporting 1.3.4Changes to the European legislation made in 2004 introduced a legal requirement to ensure that all patient information leaflets reflect the results of consultations with target patient groups. Consequently, consultations with target patient groups is required on the mock-up of the package leaflet, however, articles 59(3) and 61(1) of Directive 2001/83/EC do not define how this consultation should be done. Therefore “user testing” is permitted as a form of user consultation.

As per the Guideline on the readability of the labelling and package leaflet of medicinal products for human use, user testing means to test the readability of a specimen with a group of selected test subjects. This guideline also provides an example of a method that could be used for consultation with target patient groups. Such a method involves generating a protocol for each test, identifying the safety messages in the package leaflet and drawing up a questionnaire to address these safety issues. One-to-one, face-to-face, interviews then challenge the package leaflet to meet pre-set success criteria.

While all package leaflets must reflect the results of user consultation a full test is not always necessary. It may be possible to refer to user testing already carried out on another package leaflet that is sufficiently similar in content and layout (bridging). The results of the user testing or justification for not carrying out a full test it is then submitted in Module 1.3.4 of the application.

If you would like to speak to us about the above or seek our advice then call us on 00353 52 61 76706 or complete the form below.

Further Reading

What You Need To Know About Medicinal Product Labelling

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. Read more here.

Package Information Leaflets: An Overview

Acorn Regulatory’s consultants are package information leaflet experts.  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. Read more here.

Can Improvements Be Made To The Readability of Package Leaflets?

In this article we look at the possible changes that could be made to package leaflets to improve their comprehension and readability.  Read more 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