Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Protocols and templates for data reporting by Member States
The Agency shall make available protocols and templates for data reporting, in order to assist the Member States when applying the format of the data to be submitted by Member States to the Agency.
Assistance to Member States on data quality management
1. The Agency shall validate the data collated and reported by Member States, once it has assessed that the data fulfil the quality requirements laid in Article 6. 2. In the event that the Agency assesses that part or the totality of the reported data does not fulfil the quality requirements laid in Article 6 the Agency shall: (a) inform the relevant Member States of the necessary actions they shall take in order to ensure compliance with those requirements; (b) request the relevant Member States to amend the reported data accordingly, so that data gaps, errors and inconsistencies are eliminated. 3. The Agency shall organise trainings on data quality requirements and data quality management. The Agency shall provide targeted assistance, as appropriate, to those Member States setting up new antimicrobial data collection systems upon their request.
Web interface for collated data reporting by Member Sates
1. The Agency shall develop and maintain a web interface allowing Member States, by electronic means and in a timely manner, to: (a) report to the Agency their collated data on the volume of sales of veterinary antimicrobial medicinal products and their data on the use of antimicrobial medicinal products in animals per animal species; (b) receive instant data quality preliminary assessments, based on automated data entry checks upon reporting their data; (c) provide any amendments to the data reported that are necessary to eliminate data gaps, errors and inconsistencies; (d) verify and validate relevant animal population data gathered by the Agency and where necessary amend these data, as referred to in Article 16(5). 2. The web interface shall be available at least in the English language. 3. The Agency shall conduct validation activities to ensure that the web interface meets the minimum requirements for its specified application and intended use. 4. The Agency shall organise regular trainings, and, as appropriate, provide additional specific assistance to Member States on the use of the web interface and the completion of the relevant reporting templates.
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