Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Protection of commercially confidential information
Data on the annual volume of sales of veterinary medicinal products shall be visible in the Union product database only to the relevant competent authorities, the Commission and the Agency, as well as to the marketing authorisation holders to whose veterinary medicinal products those data refer.
Security of exchange of information
1. The Agency, in collaboration with the competent authorities and the Commission and in consultation with marketing authorisation holders, shall submit the Union product database to security testing procedures prior to putting it into operation. 2. The Agency shall ensure that the Union product database components accessible over the internet are sufficiently protected against risks of cybercrime throughout the database’s lifetime. 3. The Agency shall make it mandatory for super users and controlled users to undergo authentication and authorisation procedures each time they use the Union product database. 4. The Agency shall ensure the secure storage and exchange of all data stored in the Union product database using security protocols and connectivity rules from non-proprietary open standards established by international standards bodies or organisations. 5. The Agency shall limit access to the types of information that only super users and controlled users are permitted to access and to the functions only they are permitted to exercise. The access policy provided for in Article 13 shall conform to the security classification of the data exposed and follow the Agency’s security requirements, ensuring the segregation of responsibilities and restricting access to data. 6. The Agency shall ensure that the Union product database provides audit trail and traceability of: (a) regulatory actions performed therein by super users or controlled users; and (b) changes to the datasets contained therein made by super users or controlled users.
Access policy for super users and controlled users
1. The Agency shall, in collaboration with the competent authorities and the Commission and in consultation with marketing authorisation holders, develop and maintain an access policy. 2. The access policy shall establish the access levels permitted for super users in a manner that ensures the proper functioning of the Union product database while also safeguarding commercially confidential information and personal data and ensuring that the specifications of the Union product database laid down in this Regulation are respected. 3. The Agency shall be responsible for the management of access rights of super users for the Union product database as laid down in the access policy. 4. Super users shall be responsible for managing the access rights of controlled users in respect of the datasets for veterinary medicinal products under their responsibility. That shall not relieve super users of their legal responsibility.
Access for the general public
1. The general public shall be able to view and perform advanced searches by one or more criteria based on the data fields contained in the Union product database on the publicly available information contained therein with the possibility to export the search results. 2. No registration, authorisation or authentication shall be required for access to publicly available information by the general public. That access shall also be free of charge.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.