[fb-exchange] FW: EMA consultation of people with visual impairments

From: "Cearbhall O'Meadhra" <cearbhall.omeadhra@xxxxxxx>
To: <fb-exchange@xxxxxxxxxxxxx>
Date: Fri, 16 Feb 2024 12:00:00 -0000

From: Mary Lavelle <marylavelle58@xxxxxxxxx>
Sent: Thursday, February 15, 2024 7:11 PM
To: O'Meadhra Cearbhall <cearbhall.omeadhra@xxxxxxx>
Subject: Fwd: EMA consultation of people with visual impairments

Sent from my iPhone

Begin forwarded message:

From: StakeholdersDB <StakeholdersDB@xxxxxxxxxxxxx
<mailto:StakeholdersDB@xxxxxxxxxxxxx> >
Date: 12 February 2024 at 3:38:45 p.m. GMT
To: StakeholdersDB <StakeholdersDB@xxxxxxxxxxxxx
<mailto:StakeholdersDB@xxxxxxxxxxxxx> >
Subject: EMA consultation of people with visual impairments

<http://www.ema.europa.eu/ema/>

EMA would like to consult people living with visual impairments on an issue
relating to the information provided in Braille on the packaging of medicinal
products using this survey link:
https://ec.europa.eu/eusurvey/runner/QRD-Braille

According to the
<https://health.ec.europa.eu/system/files/2016-11/2009_01_12_readability_guideline_final_en_0.pdf>
Guideline on the readability of the labelling and package leaflet of medicinal
products for human use, only the (invented) name of the medicinal product and
its strength should be put in Braille on the packaging of the product.

Currently, it is not required to include information on the pharmaceutical form
in Braille to distinguish between injectables, such as solutions for injection
in pre-filled pen, in pre-filled syringe and in a vial.

On the one hand, it is important that all patients have the possibility of
correctly identifying their medicinal products, while concerns include the
impact of the inclusion of additional Braille text due to space constraints on
packs, in particular multilingual text and possible impairment of readability
for non-Braille users.

Your input will be shared with the Working Group on Quality Review of Documents
(QRD group) that, among other activities, promotes legibility of product
information to prevent medication errors.

This survey will be open until 4 March 2024.

Jose Antonio Fernández Abad

Public and Stakeholders Engagement Department

Stakeholders and Communication Division

European Medicines Agency

Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
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Hi  Cearbhall  would you be so kind as to circulate this request to the group
please many thanks, Mary

[fb-exchange] FW: EMA consultation of people with visual impairments

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