CELEX: 
Language: en
Date: 2022-02-16 00:00:00
Title: COMMISSION IMPLEMENTING REGULATION (EU) /... 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

EUROPEAN
                              COMMISSION
                                                       Brussels, 16.2.2022
                                                       C(2022) 864 final
                COMMISSION IMPLEMENTING REGULATION (EU) …/...
                                           of 16.2.2022
   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)
EN                                                                                            EN
 ---pagebreak---                   COMMISSION IMPLEMENTING REGULATION (EU) …/...
                                                 of 16.2.2022
   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)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of
   11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC1,
   and in particular Article 57(4) thereof,
   Whereas:
   (1)    Commission Delegated Regulation (EU) 2021/5782 sets out the requirements for the
          collection of data on the volume of sales and on the use of antimicrobial medicinal
          products in animals.
   (2)    In order for Member States to be able to collect and report such data to the European
          Medicines Agency (‘the Agency’), the format of such data should be clearly defined.
   (3)    The required format of the data should apply to the data collected for the
          antimicrobials referred to in Articles 1 to 4 of Delegated Regulation (EU) 2021/578 in
          order to have harmonised and comparable data. The required format of the data should
          equally apply to data collected on antimicrobials contained in medicated feed and
          intermediate products, in line with Article 4(4) of Regulation (EU) 2019/43.
   (4)    The format, which Member States are to use for reporting antimicrobial sales and use
          data to the Agency, should take into account specific data variables that need to be
          provided per product presentation in order to enable the Agency to calculate the
          quantity of antimicrobial active substances from veterinary medicinal products sold
          per Member State for use on its territory during the year of data collection. Those data
          variables should also enable the Agency to calculate the quantity of antimicrobial
          active substances from medicinal products used in designated animal species or
          categories per Member State on its territory during the year of data collection.
          Additional data variables should be provided by Member States to the Agency, per
          reporting year, in order to allow for an accurate analysis and interpretation of the data.
   1
           OJ L 4, 7.1.2019, p. 43.
   2
           Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU)
           2019/6 of the European Parliament and of the Council with regard to requirements for the collection of
           data on the volume of sales and on the use of antimicrobial medicinal products in animals (OJ L 123,
           9.4.2021, p. 7).
   3
           Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the
           manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005
           of the European Parliament and of the Council and repealing Council Directive 90/167/EEC, OJ L 4,
           7.1.2019, p. 1.
EN                                                       1                                                        EN
 ---pagebreak---    (5)  The Agency should provide the necessary supporting information to Member States in
        order to facilitate the harmonised calculation of the volume of sales and of the use of
        antimicrobials and to facilitate subsequent data validation by Member States before
        reporting to the Agency. Such supporting information is to be provided to Member
        States by the Agency through the web interface for collated data reporting referred to
        in Article 10 of Delegated Regulation (EU) 2021/578.
   (6)  In addition, the Agency should minimise the efforts required by Member States to
        enter data in the web interface, by pre-filling data entry fields whenever data is already
        available from existing databases under the remit of the Agency. At the same time, in
        line with Article 6 of Delegated Regulation (EU) 2021/578, Member States remain
        responsible for the fulfilment of the data quality requirements with respect to the
        information provided on the antimicrobial medicinal products authorised at national
        level, including the accuracy of the information provided by the Agency in those pre-
        filled data entry fields.
   (7)  To ensure that the data collected on the sales and the use of antimicrobials is
        comparable year-over-year within Member States and within the Union and that those
        data are adequately analysed, the format for reporting of the data should take into
        account the size of the animal population that is likely to be treated with
        antimicrobials. This should also facilitate the comparison of data reported at national
        level and at Union level with data available from non-Union countries and at global
        level. It is therefore important to define the format according to which the animal
        population data should be referred to. Any comparison of data across Member States
        should take into account the diversity of practices within the Union and the differences
        in national legal contexts.
   (8)  The most appropriate format for the animal population data as regards terrestrial
        animals should be the number of living animals or the number of slaughtered animals,
        depending on the animals species or categories concerned, while the most appropriate
        format for the animal population data as regards farmed fish should be the produced
        biomass. However, in order to appropriately reflect each Member State’s animal
        population data in the context of the collection of data on the volume of sales and on
        the use of antimicrobials in animals, so that it can be effectively used by the Agency,
        the animal population data should be adjusted according to so-called denominators,
        such as the population correction unit or other denominators, as appropriate. Such
        adjustments are necessary for the Agency to identify trends in the volume of sales and
        the use of antimicrobials in animals and make relevant analyses.
   (9)  This Regulation is necessary for the application of Regulation (EU) 2019/6, which
        applies from 28 January 2022. Therefore, and in accordance with Article 153(1) of
        Regulation (EU) 2019/6, this Regulation should apply from that same date.
   (10) The measures provided for in this Regulation are in accordance with the opinion of the
        Standing Committee on Veterinary Medicinal Products referred to in Article 145 of
        Regulation (EU) 2019/6,
EN                                               2                                                 EN
 ---pagebreak---    HAS ADOPTED THIS REGULATION:
                                              Article 1
       Data to be reported to the Agency on the volume of sales of veterinary antimicrobial
                                          medicinal products
   1.       Data on the volume of sales of veterinary antimicrobial medicinal products shall be
            reported by the Member States to the Agency using the format specified in Annex I.
   2.       The Agency shall include the format of the data referred to in paragraph 1 in the
            protocols and templates it makes available to the Member States, as provided for in
            Article 8 of Delegated Regulation (EU) 2021/578. The terminology used in the
            Agency’s protocols and templates for reporting shall be based on controlled terms
            defined in existing catalogues of terms maintained by the Agency, as much as
            possible.
                                              Article 2
       Data to be reported to the Agency on the use of antimicrobial medicinal products in
                                               animals
   1.       Data on the use of veterinary antimicrobial medicinal products shall be reported by
            the Member States to the Agency through the web interface referred to in Article 10
            of Delegated Regulation (EU) 2021/578, using the format specified in Annex II.
   2.       The Agency shall include the format of the data referred to in paragraph 1 in the
            protocols and templates it makes available to the Member States, as provided for in
            Article 8 of Delegated Regulation (EU) 2021/578. The terminology used in the
            Agency’s protocols and templates for reporting shall be based on controlled terms
            defined in existing catalogues of terms maintained by the Agency, as much as
            possible.
                                              Article 3
        Information to be provided by the Agency for calculation and validation purposes
   When providing the information necessary for the purposes of calculating the volume of sales
   and of the use of antimicrobials and validating data, the Agency shall use the variables
   specified in Annex III.
                                              Article 4
                                       Animal population data
   1.       Data identified by the Agency or reported by the Member States on the relevant
            animal populations, as specified in Article 16(5) of Delegated Regulation (EU)
            2021/578, shall take into account animal species, categories and stages thereof as
            listed in Article 15 of Delegated Regulation (EU) 2021/578 according to the
            following format:
            (a)   for terrestrial animals: the number of animals per year (living animals or
                  slaughtered animals, depending on the animal species or categories concerned,
                  as specified in the Agency’s protocols and templates for the reporting of data);
            (b)   for farmed fish: the biomass produced per year (live weight at slaughter).
EN                                                3                                                EN
 ---pagebreak---    2.        While identifying or reporting the data on the relevant animal populations, the
             Agency or the Member States, as specified in Article 16(5) of Delegated Regulation
             (EU) 2021/578, shall take into account the number of animals brought in from other
             Member States and sent to other Member States for fattening or slaughter, for the
             relevant animals species, categories and stages thereof, when appropriate, in
             accordance with the Agency’s protocols and templates referred to in Article 8 of
             Delegated Regulation (EU) 2021/578.
   3.        When Member States report the data on the relevant animal populations in their
             territories, they shall submit to the Agency a detailed description of the
             methodologies they used to generate the relevant animal population data.
                                                Article 5
                   Adjustments to the animal population data for analysis purposes
   1.        The Agency shall adjust the data for the relevant animal populations referred to in
             Article 4 according to so-called denominators, which are calculated on the basis of a
             combination of the number of animals slaughtered and of the number of live animals
             present in a Member State during the data collection period, multiplied by
             standardised animal weights.
   2.        Depending on the data concerned, the most appropriate denominator to be used shall
             be indicated in the Agency’s protocols and templates referred to in Article 8 of
             Delegated Regulation (EU) 2021/578.
   3.        The data sources and the methodology for the calculation by the Agency of the
             different denominators shall be specified in the Agency’s protocols and templates
             referred to in Article 8 of Delegated Regulation (EU) 2021/578.
                                                Article 6
   This Regulation shall enter into force on the twentieth day following that of its publication in
   the Official Journal of the European Union.
   It shall apply from 28 January 2022.
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 16.2.2022
                                                  For the Commission
                                                  The President
                                                  Ursula VON DER LEYEN
EN                                                  4                                               EN
 ---documentbreak---                               EUROPEAN
                              COMMISSION
                                                       Brussels, 16.2.2022
                                                       C(2022) 864 final
                                                       ANNEXES 1 to 3
                                           ANNEXES
                                              to the
                 COMMISSION IMPLEMENTING REGULATION (EU) .../...
   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
EN                                                                                            EN
 ---pagebreak---                                                                        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
  1. Data to be reported per product presentation
      1       ISO Country Code                    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 A choice of yes/no to be selected to indicate whether the product is allowed for use under Article
              of Regulation (EU) 2019/6           116 of Regulation (EU) 2019/6.
      4       Identification from the Union Structured data field to indicate the permanent and unique identification from the Union product
              product database of the veterinary database of the veterinary antimicrobial medicinal product presentation, in line with Article 12(1)
              medicinal product presentation      of Delegated Regulation (EU) 2021/578.
      5       Reference number from other Open-text field to indicate the reference number from other relevant database(s), such as national
              relevant     database(s)  of    the database(s), of the veterinary antimicrobial medicinal product presentation. Optional for Member
              veterinary     medicinal    product 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.
EN                                                                           1                                                                         EN
 ---pagebreak---    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             Code to be selected as per the latest version of the ATCvet index.
      Therapeutic Chemical classification
      code for veterinary medicinal
      products
   11 Authorised for companion animals    A choice of yes/no, to be selected to indicate if the veterinary antimicrobial medicinal product is
      only                                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.
   13 Name of the antimicrobial active    Name to be selected from a pre-defined list of antimicrobial active substances, in line with the
      substance                           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.
   14 Name of the salt of the             Name of the salt to be selected from a pre-defined list, in line with the Agency’s latest protocols
      antimicrobial active substance      and templates, when applicable, in order to enable the conversion to mass of active substance in a
      when strength expressed in          standardised manner.
      international unit (IU)
   15 Name of the derivative or           Name of the derivative or compound to be selected from a pre-defined list, in line with the
      compound of the antimicrobial       Agency’s latest protocols and templates, when applicable, to enable the calculation of the mass of
EN                                                                  2                                                                         EN
 ---pagebreak---              active substance                      the antimicrobial active moiety in a standardised manner.
     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.
     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 provider(s)                      Data provider(s) to be selected from a pre-defined list including:
                                                   -   Marketing Authorisation Holders;
                                                   -   Wholesalers;
                                                   -   Retailers;
                                                   -   Feed mills;
                                                   -   Pharmacies;
                                                   -   Veterinarians.
     19      Contact details of the national       Open-text field to identify and provide the contact details of the national contact point and of the
             contact point and data managers       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.
     20      Actions taken to avoid double         A choice of yes/no to be selected to indicate if necessary actions have been taken or not to avoid
             reporting of sales                    double reporting of sales.
     21      Correction of the data reported on    A choice of yes/not applicable to be selected to confirm whether the data reported on the sales of
             the sales of veterinary antimicrobial veterinary antimicrobial medicinal products in the territory of the Member State has been corrected
             medicinal products, in relation to    for movements of such products across the Member State’s borders as part of parallel trade, in
             movements of veterinary medicinal
EN                                                                              3                                                                         EN
 ---pagebreak---    products approved for parallel trade accordance with Article 102 of Regulation (EU) 2019/6.
EN                                                               4                             EN
 ---pagebreak---                                                                         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 Structured data field to indicate:
              database of the medicinal product - the permanent and unique identification from the Union product database of the
              presentation
                                                                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 Open-text field to indicate the reference number from other relevant database(s), such as
              database(s) of the medicinal product national database(s), of the antimicrobial medicinal product presentation. Optional for
              presentation                                  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
EN                                                                           5                                                                             EN
 ---pagebreak---                                                     protocols and templates.
    8 Identification  of  long-acting    parenteral Two-letter code (LA) for injectable products only, when applicable, in order to identify
      products                                      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                Code to be selected as per the latest version of the ATC or ATCvet indexes.
      Therapeutic Chemical classification code for
      human and veterinary medicinal products
   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
EN                                                                   6                                                                           EN
 ---pagebreak---                                                           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 Name of the salt to be selected from a pre-defined list, in line with the Agency’s latest
             substance, when strength is expressed in     protocols and templates, when applicable, in order to enable the conversion to mass of
             international unit (IU)                      active substance in a standardised manner.
     15      Name of the derivative or compound of the    Name of the derivative or compound to be selected from a pre-defined list, in line with the
             antimicrobial active substance               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;
EN                                                                         7                                                                           EN
 ---pagebreak---                                                     -   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 Open-text field to identify and provide the contact details of the national contact point and
      and data managers                             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.
EN                                                                    8                                                                           EN
 ---pagebreak---                                                                   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 Conversion factor assigned automatically by the Agency in the web interface, when the
         active substance, when strength is expressed strength of the antimicrobial active substance is reported in IU and the substance is
         in international units (IU)                   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 Conversion factor assigned automatically by the Agency in the web interface, when the
         compound of the antimicrobial active strength is reported for the derivative or compound and not for the antimicrobial active
         substance                                     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 Content of antimicrobial active substance per gram of product presentation.
         per presentation                              This information variable shall enable the calculation of the volume of sales and of the
                                                       use.
    4    Unit of antimicrobial active substance per Unit of measurement of the content of antimicrobial active substance per presentation in
         product presentation                          grams.
                                                       This information variable shall enable the calculation of the volume of sales and of the
                                                       use.
    5    Tonnes of antimicrobial active substance Volume of sales and use (in tonnes) of antimicrobial active substance per product
EN                                                                      9                                                                           EN
 ---pagebreak---    sold or used presentation.
                This information variable shall enable further analysis and interpretation of data.
EN                             10                                                                   EN