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Regulation (EU) 2019/4 of the European Parliament and of the CouncilShow full title

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 (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

    1. Article 1.Subject matter

    2. Article 2.Scope

    3. Article 3.Definitions

  3. CHAPTER II MANUFACTURE, STORAGE, TRANSPORT AND PLACING ON THE MARKET

    1. Article 4.General obligations

    2. Article 5.Composition

    3. Article 6.Homogeneity

    4. Article 7.Cross-contamination

    5. Article 8.Anticipated production

    6. Article 9.Specific labelling requirements

    7. Article 10.Packaging

    8. Article 11.Advertising of medicated feed and intermediate products

    9. Article 12.Intra-Union trade and import

  4. CHAPTER III APPROVAL OF ESTABLISHMENTS

    1. Article 13.Approval obligations

    2. Article 14.Lists of approved establishments

    3. Article 15.Transitional measures concerning the implementation of the requirements for approval and registration

  5. CHAPTER IV PRESCRIPTION AND USE

    1. Article 16.Prescription

    2. Article 17.Use of medicated feed

    3. Article 18.Collection or discard systems of unused or expired products

  6. CHAPTER V PROCEDURAL AND FINAL PROVISIONS

    1. Article 19.Amendment of Annexes

    2. Article 20.Exercise of the delegation

    3. Article 21.Committee procedure

    4. Article 22.Penalties

    5. Article 23.Amendment to Regulation (EC) No 183/2005

    6. Article 24.Transitional measures

    7. Article 25.Repeal

    8. Article 26.Entry into force and application

  7. Signature

    1. ANNEX I

      SPECIFIC REQUIREMENTS FOR FEED BUSINESS OPERATORS IN ACCORDANCE WITH ARTICLE 4

      1. SECTION 1 Facilities and equipment

        1. 1. Feed business operators shall ensure that facilities and equipment and...

        2. 2. Feed business operators shall ensure that access to all facilities...

      2. SECTION 2 Personnel

        1. 1. An adequately trained person responsible for the manufacture, placing on...

        2. 2. With the exception of mobile mixers and on-farm mixers, the...

      3. SECTION 3 Manufacture

        1. 1. Feed business operators shall take account of requirements under relevant...

        2. 2. Medicated feed and intermediate products shall be stored separately from...

        3. 3. Veterinary medicinal products shall be stored in a separate secured...

        4. 4. The material used for cleaning the production line after the...

      4. SECTION 4 Quality control

        1. 1. A quality control plan shall be drawn up in writing...

        2. 2. Specific regular own checks as well as stability tests shall...

      5. SECTION 5 Storage and transport

        1. 1. Medicated feed and intermediate products shall be stored in suitable...

        2. 2. Veterinary medicinal products shall be stored in separate, safe and...

        3. 3. Specific facilities shall be identified for the storage of expired,...

        4. 4. Containers in vehicles used for the transport of medicated feed...

      6. SECTION 6 Record-keeping

        1. 1. Feed business operators manufacturing, storing, transporting or placing on the...

        2. 2. The record referred to in paragraph 1 of this Section...

      7. SECTION 7 Complaints and product recall

        1. 1. Feed business operators placing medicated feed and intermediate products on...

        2. 2. Feed business operators shall put in place a system for...

      8. SECTION 8 Additional requirements for mobile mixers

        1. 1. Mobile mixers shall have a copy of the following documents...

        2. 2. Mobile mixers shall take all the appropriate precautionary measures to...

        3. 3. Where vehicle registration plate numbers are available, mobile mixers shall...

    2. ANNEX II

    3. ANNEX III

      SPECIFIC LABELLING REQUIREMENTS REFERRED TO IN ARTICLE 9(1)

      1. The label of medicated feed and intermediate products shall include...

      2. the expression ‘Medicated feed’ or ‘Intermediate product for the manufacturing...

      3. Points 1 to 10 shall not apply to mobile mixers...

    4. ANNEX IV

      PERMITTED TOLERANCES FOR THE COMPOSITIONAL LABELLING OF MEDICATED FEED OR INTERMEDIATE PRODUCTS AS REFERRED TO IN ARTICLE 9(3)

      1. The tolerances laid down in this Annex shall only include...

      2. Where the composition of a medicated feed or an intermediate...

      3. For the other active substances, the following tolerances shall apply:...

    5. ANNEX V

      INFORMATION TO BE INCLUDED IN THE VETERINARY PRESCRIPTION FOR MEDICATED FEED AS REFERRED TO IN ARTICLE 16(6)

      1. VETERINARY PRESCRIPTION FOR MEDICATED FEED

        1. 1. Full name and contact details of the veterinarian including, if...

        2. 2. Issue date, unique number of prescription, expiry date of prescription...

        3. 3. Full name and contact details of the animal keeper, and...

        4. 4. Identification (including category, species and age) and number of animals...

        5. 5. Diagnosed disease to be treated. In the case of immunological...

        6. 6. Designation (name and marketing authorisation number) of the veterinary medicinal...

        7. 7. If the veterinary medicinal product is prescribed under Article 107(4),...

        8. 8. Inclusion rate of the veterinary medicinal product or products and...

        9. 9. Quantity of medicated feed.

        10. 10. Instructions for use for the animal keeper, including the duration...

        11. 11. Percentage of medicated feed in the daily ration or quantity...

        12. 12. For food-producing animals, withdrawal period, even if such period is...

        13. 13. Any warnings necessary to ensure the proper use including, where...

        14. 14. For food-producing animals and fur animals, the mention ‘This prescription...

        15. 15. The following mentions to be completed by the supplier of...

        16. 16. Signature of supplier to the animal keeper or of on-farm...

    6. ANNEX VI

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