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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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SECTION 6 Record-keeping

1.Feed business operators manufacturing, storing, transporting or placing on the market medicated feed and intermediate products shall keep in a record relevant data, comprising details of purchase, manufacturing, storage, transport and placing on the market for effective tracing from receipt to delivery, including export to the final destination.

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

(a)

the HACCP documentation referred to in point (g) of Article 6(2) and in Article 7(1) of Regulation (EC) No 183/2005;

(b)

the quality control plan provided for in Section 4 of this Annex and the results of the relevant controls;

(c)

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;

(d)

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;

(e)

specifications and quantities of the batches of medicated feed and intermediate products which have been stored or transported;

(f)

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;

(g)

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;

(h)

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

(i)

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.

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