New regulation for variations of the dossiers for marketing authorization for medicines for human use: warning

Waiting for the update of the computer programme, the FAMHP requires applicants for marketing authorization for medicines for human use to attach to the automatic e-mails received between 01/01/2010 and the date of the adjustment of these mails, the new versions of the templates (see the document: Automatic mails).

A concrete example:
On January 4th you receive an acknowledgment that we received your mail. This mail will not include the correct content since it is based on legislation in force before 01.01.2010 and not on the new "variations" regulation that came into effect from 01/01/2010. To know the exact content of the mail you are requested to consult the document that lists all new templates for automatic mails and select the "Acknowledgment of receipt mail”.
Please use the automatic e-mail sent by FAMHP and attach the template of the corresponding new automatic mail: the dossier’s data mentioned in the "old" mail sent automatically by FAMHP will apply to the new template of the attached mail.






Last updated on 05/01/2010