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Quality Declaration

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

Important changes requiring a new readability test:


The French pharmaceutical authorities (AFFSAPS) stress that
an “important change” of the patient information leaflet concerns
especially changes of the following parts (non-exhaustive list and
subject to change, for further information: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ):

- Effects
- Side effects
- Special warnings
- Serious and/or frequent undesirable effects
- Therapeutic diagram
- Change of the prescription status (especially from
compulsory medical prescription to optional medical prescription)
Every lack of enclosure of the readability test results, when a
therapeutic change has taken place prior to the renewal application,
has to be carefully justified.



Please be informed that in case of an important change of the leaflet,
it is indeed possible to conduct a test only focused on the modified
parts (for further information: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ).


 
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