At European Community level, Article 5 (1) of Directive 2001/83/EC, duly amended provides an option for Member States to authorise in some specific cases, the exceptional use of medicinal products that have not been granted marketing authorisations (MA).

In France, the exceptional use of pharmaceutical products that do not have a MA and are not used in clinical trials is covered by obtaining a Temporary Authorisation for Use (ATU) in advance. Such authorisation is delivered by the French National Agency for Medicines and Health Products Safety (ANSM) and is aimed for medicinal products intended to treat serious or rare diseases when no appropriate treatment exists and the initiation of treatment cannot be deferred.

EUDRAC has developed expertise in early access program registration procedures. Specific guidance regarding ATU registration in France can be foundĀ here.

Please contact us directly for queries on how EUDRAC can assist you with your EAP.