Format for the reporting of data to the Agency on the volume of sales of veterinary antimicrobial medicinal products Number
Name of the data variable
17.2.2022
ANNEX I
Description
EN
1.
Data to be reported per product presentation Two-letter code (alpha-2 code), according to the International Standard for country codes (ISO, 2013); XI for Northern Ireland.
2
Year
Four-digit number.
3
Allowed for use under Article 116 of Regulation (EU) 2019/6
A choice of yes/no to be selected to indicate whether the product is allowed for use under Article 116 of Regulation (EU) 2019/6.
4
Identification from the Union product database of the veterinary medicinal product presentation
Structured data field to indicate the permanent and unique identification from the Union product database of the veterinary antimicrobial medicinal product presentation, in line with Article 12(1) of Delegated Regulation (EU) 2021/578.
5
Reference number from other relevant Open-text field to indicate the reference number from other relevant database(s), such as national database(s), of the veterinary database(s) of the veterinary medicinal product antimicrobial medicinal product presentation.
Optional for Member States. presentation
6
Name of the medicinal product
Open-text field to include the name of the veterinary antimicrobial medicinal product as per product information.
7
Product form
Product form, to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates.
8
Pack size
Numerical value only, to indicate the content quantity in the pack size.
9
Pack size unit
Unit of measurement of the pack size content, to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates.
The unit of measurement of the pack size content shall correspond to the unit of measurement of strength of the antimicrobial active substance.
10
ATCvet code: Anatomical Therapeutic Chemical classification code for veterinary medicinal products
Code to be selected as per the latest version of the ATCvet index.
11
Authorised for companion animals only
A choice of yes/no, to be selected to indicate if the veterinary antimicrobial medicinal product is authorised for use in companion animals only.
12
Number of packages sold
Numerical value to indicate the number of packages of product presentation sold within the reporting year in the reporting Member State.
L 35/11
ISO Country Code
Official Journal of the European Union
1