Since Québec is now participating in the pan-Canadian Pharmaceutical Alliance (pCPA), INESSS recently communicated that information sharing has now become necessary to ensure greater efficiency when conducting drug reviews.
As of February 15, 2016, a supplementary document, supporting authorization of information sharing with pCPA, must accompany any drug submission application pertaining to generic drugs. Drug submissions for generic drugs omitting the inclusion of this new document (i.e., letter) will be deemed incomplete by INESSS. The document must be completed, dated and signed when filed with INESSS. A template of the new letter required, entitled “Lettre d’autorisation de partage d’information avec l’APP”, is available on INESSS’ website.
In light of this update, the Fiche 3 and 4 have also been updated to reflect this new requirement.
For more information, please consult INESSS’ website.