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Commission Delegated Regulation (EU) 2016/161Show full title
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
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Article 32Structure of the repositories system
1.The repositories system shall be composed of the following electronic repositories:
(a)a central information and data router (‘hub’);
(b)repositories which serve the territory of one Member State (‘national repositories’) or the territory of multiple Member States (‘supranational repositories’). Those repositories shall be connected to the hub.
2.The number of national and supranational repositories shall be sufficient to ensure that the territory of every Member State is served by one national or supranational repository.
3.The repositories system shall comprise the necessary information technology infrastructure, hardware and software to enable the execution of the following tasks:
(a)upload, collate, process, modify and store the information on the safety features that enables the verification of the authenticity and identification of medicinal products;
(b)identify an individual pack of a medicinal product bearing the safety features and verify the authenticity of the unique identifier on that pack and decommission it at any point of the legal supply chain.
4.The repositories system shall include the application programming interfaces allowing wholesalers or persons authorised or entitled to supply medicinal products to the public to query the repositories system by means of software, for the purposes of verifying the authenticity of the unique identifiers and of decommissioning them in the repositories system. The application programming interfaces shall also allow national competent authorities to access the repositories system by means of software, in accordance with Article 39.
The repositories system shall also include graphical user interfaces providing direct access to the repositories system in accordance with Article 35(1)(i).
The repositories system shall not include the physical scanning equipment used for reading the unique identifier.
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