Exclusive Interview of Mrs. Sophie Lalaude in charge of the Name Work group (NWG) at the AFSSAPS (French Health Products Safety Agency) – PART II
We are only qualified to examine and issue decisions regarding the propositions of names for pharmaceuticals for human use. For instance, veterinary products are not part of our work. Moreover, our decisions only concern the name as such but not the packaging of the pharmaceutical at issue.
Does it mean that when you issue a decision as to a particular name you only consider the proposed name and not its environment?
No, we do take into account some criteria such as the means of delivery of the pharmaceutical (in hospitals, through the intermediary of therapists or pharmacists etc.), the form and the composition of the medicine etc.
Is there a way for the pharmaceutical firms to know, before filing the marketing authorization (In French known as AMM), if their candidate name is likely to be accepted?
More or less! Indeed we provide indicative opinions. But they are only provisional because potential obstacles may arise between the issuance of the provisional opinion and of the final one.
When an AMM is issued, for how long is it valid?
In principle, it lasts 5 years and can be renewed every 5 years. In this respect, the regulation will change in the future. Actually, according to the recent EU Directive, there will be no obligation of renewal. However, the marketing authorisation holder will no longer be valid if the medicine is not marketed within a 3 year period after the approval.
Are there any similarities between the decisions issued in France by the AFSSAPS and in the European Union by the EMEA?
Yes there are. Indeed, in France we have a special unit in charge of the EU procedures which works hand in hand with the EMEA particularly for all the centralised procedures. The members of this unit often liaise with London and exchange methods and decisions. Moreover they participate with the EMEA in elaborating the Guidelines (Recommendations) for the applicants.