Methods for collecting data on the volume of sales of veterinary antimicrobial medicinal products
1. For the purpose of collecting national data on the volume of sales of the veterinary antimicrobial medicinal products, as referred to in Articles 1 and 2, Member States shall consider the following data providers, as appropriate: marketing authorisation holders, wholesalers, retailers, feed mills, pharmacies or veterinarians.
2. Member States shall, as far as possible, use the data on the volume of sales provided by marketing authorisation holders to the Union product database as the primary data source for the volume of sales of the veterinary antimicrobial medicinal products registered by marketing authorisation holders. They shall correct these data in terms of movements of products across their borders as part of parallel trade and complete them with that of other data providers when appropriate. They shall ensure that the format of those data is in line with the requirements included in the protocols and templates made available by the Agency for data reporting.
Methods for reporting to the Agency data on the volume of sales of veterinary antimicrobial medicinal products
1. Member States shall report their data to the Agency on the volume of sales of the relevant antimicrobials via the web interface, using the protocols and templates made available to this end by the Agency and taking account of other relevant guidance documents produced by the Agency. When reporting their data to the Agency, Members States shall use the permanent and unique identification from the Union product database for the relevant veterinary antimicrobial medicinal product presentations, as referred to in Article 15(2) of Commission Implementing Regulation (EU) 2021/16 ( 6 ) .
2. Member States shall report, by 30 June of each year, their data on the volume of sales for the relevant veterinary antimicrobial medicinal products that were sold during the preceding calendar year for use within their respective national territories, in line with Article 6(d). They shall send their first report to the Agency by 30 June 2024.
3. Member States shall also report the following information to the Agency, via their national contact points and data managers and using the web interface:
(a)
the type of data providers from which they collected their data on the volume of sales, along with a short description of their national distribution systems for veterinary medicinal products;
(b)
the coverage and accuracy of their data on the volume of sales, together with measures taken to avoid double reporting;
(c)
any initiatives led within the country or any relevant specific factors which may explain the results observed at national level, including possible pattern changes and trends;
(d)
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.
4. Member States shall provide the information listed in paragraph 3 for the first data report by 30 June 2024 and update it subsequently in the following reporting periods, as applicable.
