Optimalisatie van de werkingsprocessen van het Bijzonder ... - KCE

66 Special Solidarity Fund KCE Reports 133
• any available information relative to the pharmaceutical quality, efficacy
and safety (bibliography, investigator’s brochure, etc.);
• a list of ongoing or scheduled clinical trials in France.
Possible decisions are:
• Granted: the following information is mentioned:
o name of the medicinal product;
o contact details of the prescribing physician;
o patient’s initials;
o treatment duration;
o contact details of the hospital pharmacist. The ATU is sent by fax then
by post to the hospital pharmacist, who informs the prescribing
physician.
• Rejected, for the following reasons notably:
o existence of a therapeutic alternative with a MA and available on the
market
o and/or absence of convincing data suggestive of a real benefit for the
patient
o and/or use requested for investigative purposes.
The rejection is sent by fax to the pharmacist, who informs the prescribing physician,
and by recorded delivery mail with acknowledgment of receipt to the prescribing
physician and the pharmacist. A reapplication may be made to the Director General of
the AFSSAPS and/or the matter may be referred to the relevant administrative court
within a period of 2 months from notification of the decision. Nominative ATU is
granted for a duration of maximally one year and can possibly be renewed.
COHORT ATU
For cohort ATU, the efficacy and the safety of use of medicinal products are strongly
presumed, taking into account the clinical trial results performed within the objective of
MA application, and that this application has been introduced or that the applicant
commits himself to introduce it in the near future.
The application file includes:
• the reasons for the application;
• a commitment to introduce an application for MA and the expected date.
• an administrative dossier including:
o if relevant, a copy of the application for MA project of ATU summary
of product characteristics (SPC), patient information leaflet and
labelling;
o project of protocol for therapeutic use and information collection;
o the titles and objectives of the ongoing clinical trials with their
progress reports and the trials planned for the same disease in France
or abroad;
o the identity of the principal investigator(s) in France and the name of
the research centre(s) concerned in France,
• A medicinal product dossier: The file contains all the pharmaceutical and
pharmaco-toxico-clinical data available at the moment of the application
(even if the studies are ongoing).
This protocol is drawn up by the manufacturer of the medicinal product concerned in
close collaboration with the ATU unit at AFSSAPS. The aim of this protocol is:
• to provide prescribing physicians with any relevant information about the
medicinal product and its use,
• to organise patients monitoring,