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Commission Implementing Regulation (EU) 2020/1995Dangos y teitl llawn

Commission Implementing Regulation (EU) 2020/1995 of 4 December 2020 amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ (Text with EEA relevance)

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This legislation may since have been updated - see the latest available (revised) version

  1. Introductory Text

  2. Article 1.Implementing Regulation (EU) 2018/1261 is amended as follows: in Article...

  3. Article 2.This Regulation shall enter into force on the twentieth day...

  4. Signature

    1. ANNEX

      Summary of product characteristics for a biocidal product family

      1. HYPRED's iodine based products

      2. Product type 3 - Veterinary hygiene (Disinfectants)

      3. Authorisation number: EU-0018397-0000

      4. R4BP asset number: EU-0018397-0000

      5. PART I FIRST INFORMATION LEVEL

        1. 1. ADMINISTRATIVE INFORMATION

          1. 1.1. Family name

          2. 1.2. Product type(s)

          3. 1.3. Authorisation holder

          4. 1.4. Manufacturer(s) of the biocidal products

          5. 1.5. Manufacturer(s) of the active substance(s)

        2. 2. PRODUCT FAMILY COMPOSITION AND FORMULATION

          1. 2.1. Qualitative and quantitative information on the composition of the family...

          2. 2.2. Type(s) of formulation

      6. PART II SECOND INFORMATION LEVEL - META SPC(S)

        1. META SPC 1

          1. 1. META SPC 1 ADMINISTRATIVE INFORMATION

            1. 1.1. Meta SPC 1 identifier

            2. 1.2. Suffix to the authorisation number

            3. 1.3. Product type(s)

          2. 2. META SPC 1 COMPOSITION

            1. 2.1. Qualitative and quantitative information on the composition of the meta...

            2. 2.2. Type(s) of formulation of the meta SPC 1

          3. 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

          4. 4. AUTHORISED USE(S) OF THE META SPC 1

            1. 4.1. Use description

              1. 4.1.1. Use-specific instructions for use

              2. 4.1.2. Use-specific risk mitigation measures

              3. 4.1.3. Where specific to the use, the particulars of likely direct...

              4. 4.1.4. Where specific to the use, the instructions for safe disposal...

              5. 4.1.5. Where specific to the use, the conditions of storage and...

          5. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

            1. 5.1. Instructions for use

            2. 5.2. Risk mitigation measures

            3. 5.3. Particulars of likely direct or indirect effects, first aid instructions...

            4. 5.4. Instructions for safe disposal of the product and its packaging...

            5. 5.5. Conditions of storage and shelf-life of the product under normal...

          6. 6. OTHER INFORMATION

          7. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1...

            1. 7.1. Trade name(s), authorisation number and specific composition of each individual...

            2. 7.2. Trade name(s), authorisation number and specific composition of each individual...

        2. META SPC 2

          1. 1. META SPC 2 ADMINISTRATIVE INFORMATION

            1. 1.1. Meta SPC 2 identifier

            2. 1.2. Suffix to the authorisation number

            3. 1.3. Product type(s)

          2. 2. META SPC 2 COMPOSITION

            1. 2.1. Qualitative and quantitative information on the composition of the meta...

            2. 2.2. Type(s) of formulation of the meta SPC 2

          3. 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

          4. 4. AUTHORISED USE(S) OF THE META SPC 2

            1. 4.1. Use description

              1. 4.1.1. Use-specific instructions for use

              2. 4.1.2. Use-specific risk mitigation measures

              3. 4.1.3. Where specific to the use, the particulars of likely direct...

              4. 4.1.4. Where specific to the use, the instructions for safe disposal...

              5. 4.1.5. Where specific to the use, the conditions of storage and...

            2. 4.2. Use description

              1. 4.2.1. Use-specific instructions for use

              2. 4.2.2. Use-specific risk mitigation measures

              3. 4.2.3. Where specific to the use, the particulars of likely direct...

              4. 4.2.4. Where specific to the use, the instructions for safe disposal...

              5. 4.2.5. Where specific to the use, the conditions of storage and...

          5. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

            1. 5.1. Instructions for use

            2. 5.2. Risk mitigation measures

            3. 5.3. Particulars of likely direct or indirect effects, first aid instructions...

            4. 5.4. Instructions for safe disposal of the product and its packaging...

            5. 5.5. Conditions of storage and shelf-life of the product under normal...

          6. 6. OTHER INFORMATION

          7. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2...

            1. 7.1. Trade name(s), authorisation number and specific composition of each individual...

            2. 7.2. Trade name(s), authorisation number and specific composition of each individual...

        3. META SPC 3

          1. 1. META SPC 3 ADMINISTRATIVE INFORMATION

            1. 1.1. Meta SPC 3 identifier

            2. 1.2. Suffix to the authorisation number

            3. 1.3. Product type(s)

          2. 2. META SPC 3 COMPOSITION

            1. 2.1. Qualitative and quantitative information on the composition of the meta...

            2. 2.2. Type(s) of formulation of the meta SPC 3

          3. 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

          4. 4. AUTHORISED USE(S) OF THE META SPC 3

            1. 4.1. Use description

              1. 4.1.1. Use-specific instructions for use

              2. 4.1.2. Use-specific risk mitigation measures

              3. 4.1.3. Where specific to the use, the particulars of likely direct...

              4. 4.1.4. Where specific to the use, the instructions for safe disposal...

              5. 4.1.5. Where specific to the use, the conditions of storage and...

            2. 4.2. Use description

              1. 4.2.1. Use-specific instructions for use

              2. 4.2.2. Use-specific risk mitigation measures

              3. 4.2.3. Where specific to the use, the particulars of likely direct...

              4. 4.2.4. Where specific to the use, the instructions for safe disposal...

              5. 4.2.5. Where specific to the use, the conditions of storage and...

          5. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3

            1. 5.1. Instructions for use

            2. 5.2. Risk mitigation measures

            3. 5.3. Particulars of likely direct or indirect effects, first aid instructions...

            4. 5.4. Instructions for safe disposal of the product and its packaging...

            5. 5.5. Conditions of storage and shelf-life of the product under normal...

          6. 6. OTHER INFORMATION

          7. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3...

            1. 7.1. Trade name(s), authorisation number and specific composition of each individual...

        4. META SPC 4

          1. 1. META SPC 4 ADMINISTRATIVE INFORMATION

            1. 1.1. Meta SPC 4 identifier

            2. 1.2. Suffix to the authorisation number

            3. 1.3. Product type(s)

          2. 2. META SPC 4 COMPOSITION

            1. 2.1. Qualitative and quantitative information on the composition of the meta...

            2. 2.2. Type(s) of formulation of the meta SPC 4

          3. 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

          4. 4. AUTHORISED USE(S) OF THE META SPC 4

            1. 4.1. Use description

              1. 4.1.1. Use-specific instructions for use

              2. 4.1.2. Use-specific risk mitigation measures

              3. 4.1.3. Where specific to the use, the particulars of likely direct...

              4. 4.1.4. Where specific to the use, the instructions for safe disposal...

              5. 4.1.5. Where specific to the use, the conditions of storage and...

          5. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4

            1. 5.1. Instructions for use

            2. 5.2. Risk mitigation measures

            3. 5.3. Particulars of likely direct or indirect effects, first aid instructions...

            4. 5.4. Instructions for safe disposal of the product and its packaging...

            5. 5.5. Conditions of storage and shelf-life of the product under normal...

          6. 6. OTHER INFORMATION

          7. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4...

            1. 7.1. Trade name(s), authorisation number and specific composition of each individual...

        5. META SPC 5

          1. 1. META SPC 5 ADMINISTRATIVE INFORMATION

            1. 1.1. Meta SPC 5 identifier

            2. 1.2. Suffix to the authorisation number

            3. 1.3. Product type(s)

          2. 2. META SPC 5 COMPOSITION

            1. 2.1. Qualitative and quantitative information on the composition of the meta...

            2. 2.2. Type(s) of formulation of the meta SPC 5

          3. 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

          4. 4. AUTHORISED USE(S) OF THE META SPC 5

            1. 4.1. Use description

              1. 4.1.1. Use-specific instructions for use

              2. 4.1.2. Use-specific risk mitigation measures

              3. 4.1.3. Where specific to the use, the particulars of likely direct...

              4. 4.1.4. Where specific to the use, the instructions for safe disposal...

              5. 4.1.5. Where specific to the use, the conditions of storage and...

            2. 4.2. Use description

              1. 4.2.1. Use-specific instructions for use

              2. 4.2.2. Use-specific risk mitigation measures

              3. 4.2.3. Where specific to the use, the particulars of likely direct...

              4. 4.2.4. Where specific to the use, the instructions for safe disposal...

              5. 4.2.5. Where specific to the use, the conditions of storage and...

          5. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5

            1. 5.1. Instructions for use

            2. 5.2. Risk mitigation measures

            3. 5.3. Particulars of likely direct or indirect effects, first aid instructions...

            4. 5.4. Instructions for safe disposal of the product and its packaging...

            5. 5.5. Conditions of storage and shelf-life of the product under normal...

          6. 6. OTHER INFORMATION

          7. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5...

            1. 7.1. Trade name(s), authorisation number and specific composition of each individual...

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