European Directive 2004/27/EC, which modified Directive 2001/83/EC, introduced important requirements to medicines’ packaging, in order to minimize medication errors and ensure the rational use of drugs.
The EMEA is now in the process of implementing the requirements set up in the Directive. One of the EMEA’s task is to produce guidelines on the readability of the label and package leaflet of medicinal products for human use. During the month of November, stakeholders were asked to send their views to the EMEA.
Response of Health Action International
Health Action International (HAI), an EPHA member, responded to the EMEA consultation (see full response below).
The main points of HAI’s response are the following:
Package leaflet
It is essential to consider the hierarchy in the information’s layout
Bringing the leaflet up-to-date still remains a problem
Labelling
According to the draft guideline, the name of the active ingredient should immediately follow the invented name.
Dosage strength should not be printed in lighter colours (yellow, light green, etc.)
In general, the labelling of primary (immediate) packaging is often neglected.
The labelling of devices included in the packaging is also relevant
There is no mention of pictograms or other drawings, which can be helpful to patients at certain occasions.
Recomendations for blind patients
It is neccessary to give consideration to devides included in the packaging as well as the outer packaging.
Consultation with target patient groups
The consultation should be done in a transparent way, taking different European regions as a reference to reflect cultural differencies, the number of patients to be consulted each time should be decided in a case by case basis.
