Regulation Of Evidence Obligations Of Keepers For Medicinal Products Which Are 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 compliance duties of animal keepers for medicinal products intended for use in animals (Tierhalter-Arzneimittel-Detection Regulation)

Non-official table of contents

ANTHV

Date of delivery: 20.12.2006

Full quote:

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

Footnote

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

The V was defined as Article 2 of the V v. 20.12.2006 I 3450 of the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry of Health and the Federal Ministry for Economic Affairs and Technology with the approval of the Federal Council. She's gem. Article 4 (1) of this Regulation entered into force on 31 December 2006. Non-official table of contents

§ 1

(1) Holes holding animals that are used for the production of food have the acquisition and application of the to carry out on-going medicinal products intended for use in these animals and not released for circulation outside the pharmacies. 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 any time, and are unchangeable.(2) In the case of
1.
medicated feedingstuffs, the evidence referred to in paragraph 1 above shall be the following: Manufacturer with the medicated feedingstuff sent the first copy of the prescription,
2.
Medicinal products delivered by a veterinarian or a veterinarian, proof according to § 13 (1) sentence 2 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 receipts such as veterinary prescriptions, invoices, delivery notes or Goods accompanied by the supplier, the type and quantity of the medicinal products purchased.
(3) The documentation provided for in paragraph 1 above is the documentation provided for in § 2. Non-official table of contents

§ 2

Companies holding animals that are used for the production of food have every application carried out by To document or have medicinal products not released for circulation outside the pharmacies to be documented or documented without delay in accordance with the provisions of sentence 2. 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.
Number, type and identity of the animals treated and, if the identification of the Animals required, their location,
2.
name of the medicine used,
3.
except in the cases of § 13 para. 1 sentence 7 of the Ordinary on veterinary skin pharmacies or § 58 (1) sentence 2 of the Medicines Act the belegning number according to § 13 para. 1 sentence 2 No. 2 of the Regulation on Veterinary Medicinal Products,
4.
administered amount of the medicinal product,
5.
Date of Application,
6.
Wait Time in Days,
7.
The name of the person who applied the medicine.
Table of contents

§ 3

(1) Persons who use medicinal products on a professional or commercial basis in animals without being admitted to the veterinary profession shall have the right to purchase and stay in the animals for use in animals to certain medicinal products which are not released for circulation outside the pharmacies. 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 type and quantity of 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 its preparation in the cases of the second sentence, in the cases in the sentence 3, and shall be submitted to the competent authority upon request.(2) Paragraph 1 shall not apply to persons who acquire medicinal products solely for use in the animals held by them and who are subject to the obligation to provide proof in accordance with § 1. Non-official table of contents

§ 4

is an administrative offence within the meaning of Section 97 (2) (31) of the Medicines Act, who intentionally or negligently
1.
contrary to § 1 para. 1 sentence 1 or § 3 para. 1 sentence 1 a proof of not, not correct or not fully leads,
2.
contrary to § 1 (1) sentence 2 or § 3 (1) sentence 4, proof not or not kept for at least five years, or not or not in time , or
3.
contrary to § 2 sentence 1, do not document an application, either correctly or not in a timely manner, or not to document correctly or in time