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Regulation on the obligation to provide evidence of animal owners for medicinal products intended for use in animals

Original Language Title: Verordnung über Nachweispflichten der Tierhalter für Arzneimittel, die zur Anwendung bei Tieren bestimmt sind

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Regulation on the compliance requirements of animal keepers for medicinal products intended for use in animals (animal-holder-medicinal products-detection regulation)

Unofficial table of contents

ANTHV

Date of completion: 20.12.2006

Full quote:

" Tierhalter-Arzneimittel-Detection Regulation of 20 December 2006 (BGBl. I p. 3450, 3453) "

Footnote

(+ + + Text evidence from: 31.12.2006 + + +) 

The V was approved as Article 2 of the V v. 20.12.2006 I 3450 by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry of Health and the Federal Ministry of Economics and Technology with the approval of the Federal Ministry of Economics and Technology of the Federal Council. She's gem. Article 4 (1) of this Treaty entered into force on 31 December 2006. Unofficial table of contents

§ 1

(1) Holds holding animals intended for the production of foodstuffs shall have medicinal products which are intended for use in these animals and which are not intended to be used for the purposes of transport outside pharmacies, by purchasing and applying the medicinal products they have referred to Proof of evidence. Evidence shall be given in a clear and generally comprehensible form, to be kept in stock at least five years from the date of its preparation and to be submitted to the competent authority upon request. They may also be kept and kept as an electronic document, provided that it is ensured that the data are available during the period of storage, can be made legible at all times and are unchangeable. (2) Paragraph 1 on the acquisition shall apply in the case of:
1.
Medicated feedingstuffs The first copy of the prescription sent by the manufacturer to the medicated feedingstuffs,
2.
Medicinal products submitted by a veterinarian or a veterinarian, the evidence provided for in the second sentence of Article 13 (1) and (3) of the Regulation on veterinary skin pharmacies,
3.
medicinal products obtained from pharmacies and subject to medical prescription, the original of the prescription,
4.
other medicinal products, special records or records, such as prescriptions, invoices, delivery notes or goods accompanied by veterinary medicinal products, from which the supplier, type and quantity of the medicinal products obtained are obtained.
(3) Proof in accordance with paragraph 1 on the application shall be the documentation according to § 2. Unofficial table of contents

§ 2

Establishments holding animals intended for the production of foodstuffs shall, without delay, in accordance with the conditions laid down in sentence 2, document any application of medicinal products which are not released for circulation outside pharmacies, or to be documented. The documentation shall be carried out in each stock of the holding and shall have the following information in a clear and generally comprehensible form and in terms of time in relation to the entire stock or to individual animals or groups of animals of the herd to be included:
1.
the number, type and identity of the animals treated and, if necessary for the identification of the animals, their location,
2.
the name of the medicinal product used,
3.
except in the cases of § 13 (1) sentence 7 of the Regulation on veterinary medicinal products or the second sentence of Section 58 (1) of the Medicinal Products Act, the belegning number in accordance with Section 13 (1), second sentence, point 2 of the Regulation on veterinary skin pharmacies,
4.
the amount of the medicinal product administered,
5.
date of application,
6.
Waiting time in days,
7.
Name of the person who used the medicine.
Unofficial table of contents

§ 3

(1) Persons who use medicinal products on a professional or commercial basis in animals without having an authorisation to pursue a veterinary profession shall have the acquisition and whereabout of the medicinal products intended for use in animals which do not: for transport outside the pharmacies are to be carried out on a basis of proof. Proof of purchase as provided for in the first sentence of the first subparagraph shall be the invoices or delivery notes issued by a pharmacy, which must result in the nature and quantity and the date of purchase of the medicinal products. The evidence provided for in the first sentence on the whereaby shall be the nature and quantity of the medicinal products used and the name and address of the person holding the veterinary medicinal product in whose animals they have applied the medicinal products. The evidence shall be kept for at least five years from the date of preparation of the sentence in the cases of the second sentence of the date of receipt of the sentence, and shall be submitted to the competent authority upon request. Persons who acquire medicinal products only for use in the animals held by them and who are subject to the obligation to provide proof according to § 1. Unofficial table of contents

§ 4

Contrary to the provisions of Section 97 (2) (31) of the Medicinal Products Act, who intentionally or negligently acts
1.
Contrary to § 1 (1) sentence 1 or § 3 (1) sentence 1, proof not, not correct or not complete,
2.
, contrary to § 1 (1) sentence 2 or § 3 (1) sentence 4, proof not or not kept for at least five years, or not presented in due time or not in time, or
3.
Contrary to § 2 sentence 1, an application shall not be documented correctly or not in good time, not correctly or in a timely manner, or not documented in good time.