π Tender Overview
This project is consistent with the actions implemented in France to improve surveillance systems of antimicrobial sales and use. Antimicrobial sales surveillance: Surveillance of antibiotic sales is in place in France since 1999 for veterinary medicine, it is based on declarations from Marketing Authorisation Holders (MAH). The aims of this project are to improve the data collection by: β’ Extending the scope of the surveillance to include other antimicrobials β’ Creating a web portal for the MAH declarations β’ Improving the links between the French and European databases Antimicrobial Use Surveillance: A French law published in 2014 requires the mandatory declaration of antibiotics delivered by feed-mill manufacturers, veterinarians and pharmacists. To collect these data, a sub-project PM4 has been launched within the CALYPSO project, which is an IT system interconnecting veterinarians and the French ministry of agriculture. The aim of the sub-project is to automatically collect prescriptions/delivery data from veterinarians, pharmacists, and feed-mill manufacturers. Currently, the detailed and functional specifications are almost finalised and the development of the CALYPSO portal has recently started. A pilot phase is foreseen to start at the end of 2022. Within this project the aim is to establish processes/programs in order to: β’ Help to qualify each veterinarians, pharmacists software to ensure that specifications are correctly implemented β’ Improve the repository of veterinary medicinal products used in the software of veterinarians and pharmacists to collect standardised information β’ Verify the quality of data through appropriate technical requirements β’ Develop procedures to address detected declaration errors β¦ β’ Check absence of declarations β’ Develop adequate programs to analyse data β’ Develop adequate programs to transmit data to the European Medicines Agency (EMA) β’ Establish a quality management plan