COMMISSION IMPLEMENTING REGULATION (EU) 2022/209
of 16 February 2022
establishing the format of the data to be collected and reported in order to determine the volume of sales and the use of antimicrobial medicinal products in animals in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
(Text with EEA relevance)
Article 1
Data to be reported to the Agency on the volume of sales of veterinary antimicrobial medicinal products
Article 2
Data to be reported to the Agency on the use of antimicrobial medicinal products in animals
Article 3
Information to be provided by the Agency for calculation and validation purposes
Article 4
Animal population data
Article 5
Adjustments to the animal population data for analysis purposes
Article 6
ANNEX I
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 |
Description |
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1 |
ISO Country Code |
Two-letter code (alpha-2 code), according to the International Standard for country codes (ISO, 2013); XI for Northern Ireland. |
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2 |
Year |
Four-digit number. |
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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. |
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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. |
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5 |
Reference number from other relevant database(s) of the veterinary medicinal product presentation |
Open-text field to indicate the reference number from other relevant database(s), such as national database(s), of the veterinary antimicrobial medicinal product presentation. Optional for Member States. |
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6 |
Name of the medicinal product |
Open-text field to include the name of the veterinary antimicrobial medicinal product as per product information. |
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7 |
Product form |
Product form, to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates. |
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8 |
Pack size |
Numerical value only, to indicate the content quantity in the pack size. |
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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. |
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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. |
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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. |
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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. |
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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 version of the ATCvet Index. In case of fixed combination products, all the antimicrobial active substances shall be reported individually. |
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14 |
Name of the salt of the antimicrobial active substance when strength 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. |
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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, to enable the calculation of the mass of the antimicrobial active moiety in a standardised manner. |
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16 |
Strength |
Numerical value of the strength or the quantity of the antimicrobial active substance(s), as declared in the product information, in order to enable the calculation of the quantity of antimicrobial active substance(s) in each product presentation. |
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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. |
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18 |
Data provider(s) |
Data provider(s) to be selected from a pre-defined list including:
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19 |
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 sales of veterinary antimicrobial medicinal products. |
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20 |
Actions taken to avoid double reporting of sales |
A choice of yes/no to be selected to indicate if necessary actions have been taken or not to avoid double reporting of sales. |
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21 |
Correction of the data reported on the sales of veterinary antimicrobial medicinal products, in relation to movements of veterinary medicinal products approved for parallel trade |
A choice of yes/not applicable to be selected to confirm whether the data reported on the sales of veterinary antimicrobial medicinal products in the territory of the Member State has been corrected for movements of such products across the Member State’s borders as part of parallel trade, in accordance with Article 102 of Regulation (EU) 2019/6. |
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 |
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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. |
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2 |
ISO Country code |
Two-letter code (alpha-2 code), according to the International Standard for country codes (ISO, 2013); XI for Northern Ireland. |
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3 |
Year |
Four-digit number. |
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4 |
Identification from the relevant Union database of the medicinal product presentation |
Structured data field to indicate:
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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. |
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6 |
Name of the medicinal product |
Open-text field to include the name of the medicinal product as per product information |
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7 |
Product form |
Product form to be selected from a pre-defined list, in line with the Agency’s latest protocols and templates. |
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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. |
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9 |
Pack size |
Numerical value only, to indicate the content quantity in the pack size. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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18 |
Data source(s) |
Data source(s) to select from a pre-defined list including:
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19 |
Data provider(s) |
Data provider(s) to select from a pre-defined list including:
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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. |
ANNEX III
Information to be provided by the Agency for calculation and validation purposes
Number |
Name of the variable to be provided |
Description |
1 |
Conversion factor for the antimicrobial active substance, when strength is expressed in international units (IU) |
Conversion factor assigned automatically by the Agency in the web interface, when the strength of the antimicrobial active substance is reported in IU and the substance is included in the pre-defined list, in line with the Agency’s latest protocols and templates. This information variable shall enable the conversion from IU to mass of the antimicrobial substance sold or used, per each product presentation. |
2 |
Conversion factor for the derivative or compound of the antimicrobial active substance |
Conversion factor assigned automatically by the Agency in the web interface, when the strength is reported for the derivative or compound and not for the antimicrobial active moiety, and the derivative or compound is included in the pre-defined list, in line with the Agency’s latest protocols and templates. This information variable shall enable the calculation of the mass of the antimicrobial active moiety sold or used, per each product presentation. |
3 |
Content of antimicrobial active substance per presentation |
Content of antimicrobial active substance per gram of product presentation. This information variable shall enable the calculation of the volume of sales and of the use. |
4 |
Unit of antimicrobial active substance per product presentation |
Unit of measurement of the content of antimicrobial active substance per presentation in grams. This information variable shall enable the calculation of the volume of sales and of the use. |
5 |
Tonnes of antimicrobial active substance sold or used |
Volume of sales and use (in tonnes) of antimicrobial active substance per product presentation. This information variable shall enable further analysis and interpretation of data. |