Advice On Supporting Module 1.3.4 Of A Medicinal Product Application
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).Changes 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.
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