Do Patient Groups Have A Role In Package Leaflet Creation?

What role do target patient groups have in the creation of a package leaflet?  We look at the issue and the directives concerning package leaflets in our blog.

Council Directive 2001/83/EC as amended by the Council Directive 2004/27/EC includes the following requirements in terms of the legibility and understanding of the package leaflets;

“The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use” (Article 59(3)).

“The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.” (Article 61 (1))

Consultations with target patient groups are therefore required for all package leaflets included in national or community authorisation applications and where significant changes are made to an existing package leaflet (e.g. new indications, new safety issue).

So how can MAHs meet these requirements?

One option is to submit a User Test Outcome Report. User testing is a process to test the readability of a package leaflet with a group of selected test participants.

Key safety issues associated with the specific medicine (e.g. side effects, warnings and precautions) are identified prior to commencement of the user testing. A questionnaire covering a balance of general and specific issues is then prepared. Testing takes the form of a series of one to one, face-to-face interviews and involves at least two rounds of 10 participants each. A satisfactory test outcome is when at least 90% of literate adults are able to find the information requested within the package leaflet, of whom at least 90% can show that they understand it.

The User Test Outcome Report should be presented in Module 1.3.4 of a new application or as Type IB variation procedure under category C.l.z.

While all package leaflets for medicines must reflect the results of consultation with target patient groups, not every package leaflet needs to be subjected to a separate test. Alternative evidence may take the format of a Bridging Report which will be discussed in a further publication.

For further information on how Acorn Regulatory can help you meet the requirements of Article 59(3) please contact us at 052 6176706 or complete your details below.

Further Reading from Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

Much has been written about orphan drugs in recent times.  These products, developed specifically to treat a rare disease, have become more common in the marketplace.  At the time of writing (May 2020), there are almost 770 orphan drugs commercially available and more than 5600 orphan designated drugs in the biopharmaceutical pipeline.

As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability.  We look at some facts about orphan designation that companies considering entering the sector should be aware of.

Read more about orphan drugs here.

Medicinal Product Labelling: What You Need To Know

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).

Read more about medicinal product labelling here.

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

  1. Companies that maintain control of electronic publishing at the corporate and head office level
  2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
  3. Companies that have outsourced eCTD entirely

In this article, we will look at the benefits and the limitations presented by the three options presented above.

Find out more about outsourcing eCTD here.