Number

Name of the data variable

Description

1

Animal species

Animal species, categories and stages thereof, for which data on the use of antimicrobial medicinal products shall be collected and reported, to be selected from a pre-defined list, in line with the requirements set in Article 15 of Delegated Regulation (EU) 2021/578.

2

ISO Country code

Two-letter code (alpha-2 code), according to the International Standard for country codes (ISO, 2013); XI for Northern Ireland.

3

Year

Four-digit number.

4

Identification from the relevant Union database of the medicinal product presentation

Structured data field to indicate:

5

Reference number from other relevant database(s) of the medicinal product presentation

Open-text field to indicate the reference number from other relevant database(s), such as national database(s), of the antimicrobial medicinal product presentation. Optional for Member States.

6

Name of the medicinal product

Open-text field to include the name of the 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

Identification of long-acting parenteral products

Two-letter code (LA) for injectable products only, when applicable, in order to identify parenteral products with long acting/prolonged release dosage forms, whose modified release dosage forms are showing slower release than that of the conventional release dosage form administered by the same route. Prolonged release is achieved through special formulation design and/or manufacturing method.

9

Pack size

Numerical value only, to indicate the content quantity in the pack size.

10

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.

11

ATC or ATCvet code: Anatomical Therapeutic Chemical classification code for human and veterinary medicinal products

Code to be selected as per the latest version of the ATC or ATCvet indexes.

12

Number of packages used

Numerical value to indicate the number of packages of product presentation used within the reporting year per Member State and per animal species, animal species category or animal species stage, as specified in Article 15 of Commission Delegated Regulation (EU) 2021/578.

In case any data at national level are collected in other units than packages used for each antimicrobial product by the animal species in question, the number of packages used may be calculated by the Member State from the amounts used (expressed in weight or in volume) before reporting to the Agency.

13

Name of the antimicrobial active substance

Name to be selected from a pre-defined list of antimicrobial active substances, in line with the Agency’s latest protocols and templates, which includes International Non-proprietary Name (INN) of antimicrobial substances, as presented according to the latest versions of the ATC or ATCvet Indexes, to report antimicrobial use in a standardised manner per antimicrobial classes and active substances.

In case of fixed combination products, all the antimicrobial active substances shall be reported individually.

14

Name of the salt of the antimicrobial active substance, when strength is expressed in international unit (IU)

Name of the salt to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates, when applicable, in order to enable the conversion to mass of active substance in a standardised manner.

15

Name of the derivative or compound of the antimicrobial active substance

Name of the derivative or compound to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates, when applicable, in order to enable the calculation of the mass of the antimicrobial active moiety in a standardised manner.

16

Strength

Numerical value of the strength or of the quantity of the antimicrobial active substance(s), as declared in the product information, to enable the calculation of the quantity of antimicrobial active substance in each product presentation.

17

Unit of measurement of strength

Unit of measurement of strength to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates. The unit of measurement of strength shall correspond to the unit of measurement of the pack size.

18

Data source(s)

Data source(s) to select from a pre-defined list including:

19

Data provider(s)

Data provider(s) to select from a pre-defined list including:

20

Contact details of the national contact point and data managers

Open-text field to identify and provide the contact details of the national contact point and of the data managers of the Member State for liaison with the Agency with regards to the reporting of data on the use of antimicrobial medicinal products in animals.