it shall be physically located in the Union;

it shall be set up and managed by a non-profit legal entity established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features and, where they have chosen to participate, wholesalers and persons authorised or entitled to supply medicinal products to the public;

it shall be fully interoperable with the other repositories composing the repositories system; for the purposes of this Chapter, interoperability means the full functional integration of, and electronic data exchange between repositories regardless of the service provider used;

it shall allow the reliable electronic identification and authentication of individual packs of medicinal products by manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public, in accordance with the requirements of this Regulation;

it shall have application programming interfaces able to transfer and exchange data with the software used by wholesalers, persons authorised or entitled to supply medicinal products to the public and, where applicable, national competent authorities;

when wholesalers and persons authorised or entitled to supply medicinal products to the public query the repository for the purposes of verification of authenticity and decommissioning of a unique identifier, the response time of the repository, not considering the speed of the internet connection, shall be lower than 300 milliseconds in at least 95 % of queries. The repository performance shall allow wholesalers and persons authorised or entitled to supply medicinal products to the public to operate without significant delay;

it shall maintain a complete record (‘audit trail’) of all operations concerning a unique identifier, of the users performing those operations and the nature of the operations; the audit trail shall be created when the unique identifier is uploaded to the repository and be maintained until at least one year after the expiry date of the medicinal product bearing the unique identifier or five years after the product has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period;

in accordance with Article 38, its structure shall be such as to guarantee the protection of personal data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public interact with it;

it shall include graphical user interfaces providing direct access to it to the following users verified in accordance with Article 37(b):

1. (i)

   wholesalers and persons authorised or entitled to supply medicinal products to the public, for the purposes of verifying the authenticity of the unique identifier and decommissioning it in case of failure of their own software;

2. (ii)

   national competent authorities, for the purposes referred to in Article 39;