In order to improve safety in the use of medicinal products in paediatrics, the Federal Council may allow for the collection, harmonisation, evaluation and publication of data relating to the prescription, supply and use of medicinal products.
The Confederation may arrange for a database to be established and operated by third parties for this purpose. This database may not contain personal data.
The Federal Council:
shall specify the basic requirements for the content, operation and quality of the database and regulate the conditions for the access to and use of the data;
determines the entity responsible for managing the database and may authorise the same to gather information in anonymised form from medical professionals.
The operators in accordance with paragraph 2 shall guarantee the interoperability of this database with the register in accordance with Article 67.
The Federal Council may extend the activities under paragraphs 1 and 2 to include further specific population groups. It may provide for the establishment of advisory committees or the consultation of experts.
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