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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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The quality control plan should define rules regarding sequencing or incompatibilities of manufacturing operations and, where applicable, define the need for dedicated production lines.
Medicated feed and intermediate products shall be stored and transported in such a way as to be easily identifiable. Medicated feed and intermediate products shall be transported in suitable means of transport.
the HACCP documentation referred to in point (g) of Article 6(2) and in Article 7(1) of Regulation (EC) No 183/2005;
the quality control plan provided for in Section 4 of this Annex and the results of the relevant controls;
specifications and quantities of veterinary medicinal products with batch number, feed materials, compound feed, feed additives, intermediate products and medicated feed which have been purchased;
specifications and quantities of the batches of medicated feed and intermediate products which have been manufactured, including the veterinary medicinal products with batch number, feed materials, compound feed, feed additives and intermediate products which have been used;
specifications and quantities of the batches of medicated feed and intermediate products which have been stored or transported;
specifications and quantities of medicated feed and intermediate products which have been placed on the market or exported to third countries, including the unique number of the veterinary prescription for medicated feed;
information on the manufacturers or suppliers of the medicated feed and intermediate products or of the products used for the manufacture of medicated feed and intermediate products, including at least their name, address and, where applicable, their approval identifying number;
information on the recipients of the medicated feed and intermediate products, including at least their name, address and, where applicable, their approval identifying number; and
information on the veterinarian, or the professional person referred to in Article 16(5), who has issued the veterinary prescription for medicated feed, including at least that veterinarian’s or that professional person’s name and address.
The documents listed in this paragraph shall be kept for at least five years in the record after their date of issuance.
Feed business operators shall define by means of written procedures the destination of any recalled products, and before such products are put back into circulation the feed business operators shall carry out a quality-control reassessment to ensure that the Union feed safety requirements are complied with.
the approval of the designated mobile mixer for the manufacture of medicated feed from the competent authority from the Member State where the mobile mixer is approved;
the HACCP documentation referred to in point (g) of Article 6(2) and in Article 7(1) of Regulation (EC) No 183/2005;
the quality control plan provided for in Section 4 of this Annex;
the cleaning plan referred to in Section 1 of this Annex;
the list of persons responsible for the manufacture of medicated feed referred to in Section 2 of this Annex.
The label of medicated feed and intermediate products shall include the following particulars, in a simple, clear and easily understandable manner for the end users:
the expression ‘Medicated feed’ or ‘Intermediate product for the manufacturing of medicated feed’ as appropriate;
the approval number of the feed business operator responsible for the labelling. In cases where the manufacturer is not the feed business operator responsible for the labelling, the following shall be provided:
the name or business name and address of the manufacturer; or
the approval number of the manufacturer;
the active substances with name, added amount (mg/kg), and the veterinary medicinal products with its marketing authorisation number and the marketing authorisation holder, preceded by the heading ‘medication’;
any contra-indications of the veterinary medicinal products and adverse events in so far as those particulars are necessary for the use;
in the case of a medicated feed or of intermediate product intended for food-producing animals, the withdrawal period or the indication ‘no withdrawal period’;
in the case of medicated feed for non-food-producing animals, except fur animals, a warning that the medicated feed is only for the treatment of animals and a warning that it must be kept out of the sight and reach of children;
a free telephone number or other appropriate means of communication in order to allow the animal keeper to obtain, in addition to the mandatory particulars, the package leaflet of each veterinary medicinal product;
the instructions for use in line with the veterinary prescription for medicated feed or the summary of the product characteristics;
the minimum storage life, which shall take into account the expiry dates of the veterinary medicinal products and shall be expressed as ‘use before…’, followed by the date, and special storage precautions, if appropriate;
information that inappropriate disposal of medicated feed poses serious threats to the environment and may, where relevant, contribute to antimicrobial resistance.
Points 1 to 10 shall not apply to mobile mixers exclusively manufacturing the medicated feed without supplying any components.
The tolerances laid down in this Annex shall only include technical deviations.
Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of 10 % shall apply.
For the other active substances, the following tolerances shall apply:
Active substance per kg of medicated feed or intermediate products | Tolerance |
---|---|
> 500 mg | ± 10 % |
≤ 500 mg | ± 20 % |
name or business name and address,
date of delivery or of on-farm mixing,
batch number of medicated feed delivered under the veterinary prescription for medicated feed, except for on-farm mixers.
Directive 90/167/EEC | This Regulation |
---|---|
Article 1 | Article 2 |
Article 2 | Article 3 |
Article 3(1) | Article 5(1) |
Article 3(2) | — |
Article 4(1) | Articles 4, 5(2), 6, 7(1), 13, 16 and Annex I |
Article 4(2) | — |
Article 5(1) | Article 10 |
Article 5(2) | Articles 4, 7 and Annex I |
— | Article 8 |
Article 6 | Article 9 and Annex III |
Article 7 | — |
Article 8(1) and (2) | Article 16 |
Article 8(3) | Article 17(6) |
Article 9(1) | Articles 13.17(1) and (2) |
Article 9(2) | — |
Article 9(3) | — |
— | Article 11 |
Article 10 | Article 12(1) |
— | Article 14 |
— | Article 15 |
— | Article 17(3), (4) and (5) |
— | Article 17(7) |
— | Article 18 |
Article 11 | — |
Article 12 | Article 19 |
— | Article 20 |
— | Article 21 |
— | Article 22 |
— | Article 25 |
— | Article 26 |
Article 13 | — |
Article 14 | Article 12(2) |
Article 15 | — |
Article 16 | — |
Annex A | Annex V |
Annex B | — |
— | Annex II |
— | Annex IV |
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