CHAPTER VIIESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM

Article 39Access 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:

  1. (a)

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

  2. (b)

    reimbursement;

  3. (c)

    pharmacovigilance or pharmacoepidemiology.