CHAPTER VII ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM

Article 39 Access by national competent authorities

A legal entity establishing and managing a repository used to verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in a Member State shall grant access to that repository and to the information contained therein, to competent authorities of that Member State for the following purposes:

(a)

supervising the functioning of the repositories and investigating potential incidents of falsification;

(b)

reimbursement;

(c)

pharmacovigilance or pharmacoepidemiology.