Operations of the repositories system
Article 36
The repositories system shall provide for at least the following operations: (a) the repeated verification of the authenticity of an active unique identifier in accordance with Article 11; (b) the triggering of an alert in the system and in the terminal where the verification of the authenticity of a unique identifier is taking place when such verification fails to confirm that the unique identifier is authentic in accordance with Article 11. Such an event shall be flagged in the system as a potential incident of falsification except where the product is indicated in the system as recalled, withdrawn or intended for destruction; (c) the decommissioning of a unique identifier in accordance with the requirements of this Regulation; (d) the combined operations of identification of a pack of a medicinal product bearing a unique identifier and verification of the authenticity and decommissioning of that unique identifier; (e) the identification of a pack of a medicinal product bearing a unique identifier and the verification of the authenticity and the decommissioning of that unique identifier in a Member State which is not the Member State where the medicinal product bearing that unique identifier was placed on the market; (f) the reading of the information contained in the two-dimensional barcode encoding the unique identifier, the identification of the medicinal product carrying the barcode and the verification of the status of the unique identifier, without triggering the alert referred to in point (b) of this Article; (g) without prejudice to Article 35(1)(h), the access by verified wholesalers to the list of wholesalers referred to in Article 33(2)(h) for the purposes of determining whether they have to verify the unique identifier of a given medicinal product. (h) the verification of the authenticity of a unique identifier and its decommissioning by manually querying the system with the data elements of the unique identifier; (i) the immediate provision of information concerning a given unique identifier to the national competent authorities and the European Medicines Agency, upon request; (j) the creation of reports that allow competent authorities to verify compliance of individual marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public with the requirements of this Regulation or to investigate potential incidents of falsification; (k) the reverting of the status of a unique identifier from decommissioned to active, subject to the conditions referred to in Article 13; (l) the indication that a unique identifier has been decommissioned; (m) the indication that a medicinal product has been recalled, withdrawn, stolen, exported, requested as a sample by national competent authorities, indicated as a free sample by the marketing authorisation holder, or is intended for destruction; (n) the linking, by batches of medicinal products, of the information on unique identifiers removed or covered to the information on the equivalent unique identifiers placed on those medicinal products for the purposes of complying with Article 47a of Directive 2001/83/EC. (o) the synchronisation of the status of a unique identifier between the national or supranational repositories serving the territory of the Member States where that medicinal product is intended to be placed on the market.