ANNEX II
Format for the reporting of data to the Agency on the use of antimicrobial medicinal products in animals
Number
Name of the data variable
Description
1.
Data to be reported per product presentation
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:
—
the permanent and unique identification from the Union product database of the veterinary antimicrobial medicinal product presentation; or
—
the Packaged Medicinal Product Identifier (PCID) from the Product Management Services (PMS) of the human antimicrobial medicinal product presentation.
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.
2.
Data to be provided per reporting year
18
Data source(s)
Data source(s) to select from a pre-defined list including:
—
Health records;
—
Treatment logbooks;
—
Delivery notes;
—
Invoices from farms;
—
Prescriptions;
—
Pharmacy records;
—
Veterinary practice records.
19
Data provider(s)
Data provider(s) to select from a pre-defined list including:
—
Veterinarians;
—
Retailers;
—
Pharmacies;
—
Feed mills;
—
End-users (including farmers or breeders).
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.
