SECTION 1 — Obligations of Member States
Data quality requirements
Data collected and reported by Member States to the Agency shall be accurate, complete and consistent. They shall at a minimum fulfil the following quality requirements:
(a)
data shall be validated and reported according to the standardised specifications of the latest reporting protocols and templates made available by the Agency, in accordance with Article 8;
(b)
upon reporting, data shall be processed through the automated data entry checks as performed by the Agency’s web interface, as referred to in Article 10;
(c)
data shall be amended in case gaps, errors or inconsistencies are identified;
(d)
data on the volume of sales shall cover all sales per Member State of at least the antimicrobials listed in point 1 of the Annex to be used on a Member State territory, including sales of those antimicrobials brought in from other Member States to be used on a Member State territory and excluding sales of those antimicrobials sent to other Member States to be used outside of a Member State territory;
(e)
data on use shall cover all use per Member State territory of at least the antimicrobials listed in point 3 of the Annex for all animal species and categories or stages listed in Article 15;
Data quality management plan, national contact point and data managers
1. For the purpose of ensuring compliance with the data quality requirements listed in Article 6, Member States shall set out a data quality management plan that comprises appropriate data quality management procedures, including procedures for data quality assurance, validation and quality control.
2. Member States shall nominate a national contact point and data managers in accordance with the data quality management procedures defined in the data quality management plan. The national contact point and data managers shall:
(a)
ensure that there is an alignment between the specifications for data reporting by the data providers to them and the specifications for data reporting by them to the Agency;
(b)
ensure that quality assurance and quality control measures are adopted and that the data to be collated and reported to the Agency are validated and approved;
(c)
use the latest reporting protocols and templates made available by the Agency, as referred to in Article 8, and take account of other relevant guidance documents produced by the Agency, such as manuals or guidelines, to allow for the collection and reporting of standardised and harmonised data to the Agency;
(d)
provide the Agency, without delay, with appropriate amendments to any reported data which the Agency would have qualified as not fulfilling the necessary data quality requirements. Such amended data may be obtained with the support of data providers where necessary;
(e)
verify and validate relevant animal population data gathered by the Agency and where necessary amend these data, as referred to in Article 16(5);
(f)
provide at the time of their first reporting, and update for the following reporting periods when necessary, a brief description of their national policy framework or main initiatives in place to fight antimicrobial resistance and reduce any use of antimicrobials in animals that is neither prudent nor responsible, in accordance with point (d) of Articles 12(3) and 13(4);
(g)
support prompt resolution of technical questions arising in relation to the data on the volume of sales and on the use of antimicrobial medicinal products reported to the Agency via the web interface;
(h)
cooperate with the Agency and with other Union agencies, where applicable, to ensure the quality of the data analyses necessary for the preparation and publication of the Agency’s reporting on the volume of sales and on the use of antimicrobial medicinal products in animals.
3. Member States shall update their data quality management plan referred to in paragraph 1, as appropriate, in order to take account of scientific and technical developments in the area.
SECTION 2 — Obligations of the Agency
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
