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Quality Declaration

In practice:
- New MA legislation
- Substantial changes
- MA Renewal


Reglementary context

Article 56 of Directive 2001/83/EC as amended by Directive 2004/27/EC requires that the particulars to be included in the labeling shall be easily legible, clearly comprehensible and indelible.

Article 59 - 3 of Directive 2001/83/EC provides that the package leaflet shall reflect the
results of consultations with target patient groups to ensure that it is legible, clear and easy
to use.

The requirements of Directive 2001/83/EC related to the leaflet as amended by Directive 2004/27/EC have been applied to national law by the Decree  n°2008-435  of May 6 2008 related to the marketing of pharmaceutical products  destined to human use.

Everything that has been added to the European procedures since 2005 must now
be applied to national procedures.


In practice

New MA application:

Article 5121-25 of the Public Health Law is amended by Article 14 of the Decree
n°2008-435 as follows: “According to the legislation of Article R. 5121-21,
the following document has to be added to the application: The draft patient
information leaflet including results regarding the readability, the legibility and
the usefulness of the leaflet from tests conducted on target patient groups.”

When applying for an MA, the French authorities do, however, allow the applicant
not to enclose the test results whenever the product is not to be sold in France. 
The applicant must though provide the authorities with the test results at least
one month prior to the marketing of the product. 

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