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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Ordinance on proof obligations of keepers for medicinal products for use in animals intended are (pet owners drug regulation) ANTHV Ausfertigung date: 20.12.2006 full quotation: "pet owners drug evidence regulation of 20 December 2006 (BGBl. I p. 3450, 3453)" footnote (+++ text detection from: 31.12.2006 +++) the V 2 V v. 20.12.2006 was adopted as article 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 Bundesrat. It is according to article 4 paragraph 1 of this V on December 31, 2006 entered into force.

Article 1 (1) establishments that hold animals which serve the production of food, have about acquisition and application of them related to lead evidence certain and not shared with the traffic outside the pharmacies pharmaceutical products for use in these animals. The evidence is clear and generally understandable form to lead, to be kept at least five years from the date of their creation to the stock and to submit to the competent authority upon request. You can be kept as electronic document and stored unless it is ensured that the data for the duration of the storage available, can be made at any time to read and are immutable.
(2) evidence pursuant to paragraph 1 for the purchase are in accordance with in the case of 1. medicated feedingstuffs the first copy of the prescription, 2. medicinal products which have been submitted, evidence by a veterinarian or a veterinary surgeon sent by the manufacturer with the medicated feed section 13, paragraph 1, sentence 2 and 3 of the regulation of veterinary house pharmacies, 3. medicinal products which have been purchased and are available by prescription from pharmacies , the original of the prescription, 4. other medicinal special records or documents such as veterinary notes, invoices, delivery notes or Warenbegleitscheine result from which supplier, type and quantity of the purchased medicines.
(3) evidence is the documentation pursuant to paragraph 1 of the application pursuant to article 2.

§ 2 holdings which keep animals which serve the production of food, have each carried out use of medicinal products which are not released for transport outside of pharmacies, immediately according to the sentence of 2 to document, or document. The documentaries are in each stock of the operation and have assigned in clear and generally understandable form and time information on the entire inventory or on individual animals or groups of animals of the portfolio to include: 1. number, type and identity of the animals treated and, if to identify the animals, whose site, 2. name of the applied medicinal, 3. except in the cases of § 13 para 1 sentence 7 of regulation over veterinary pharmacies of the House or of section 58 para 1 set 2 of the medicines Act the document number in accordance with § 13 para 1 sentence 2 No. 2 of the regulation on veterinary pharmacies of House, 4. quantity of the medicinal product, 5. date of application, 6 latency administered in days, 7. name of the person who has used the drug.

§ 3 (1) persons who work - or professional use medicines in animals, without an admission to the veterinary profession, have on acquisition and disposition of them related, intended for use in animals medicinal products which are not released for transport outside of pharmacies, to lead evidence. Evidence are the invoices issued by a pharmacy or delivery notes from which type and amount and date of the purchase of pharmaceutical products must arise pursuant to sentence 1 on the acquisition. Evidence is the type and amount of applied medicines as well as name and address of livestock, in which animals they have applied the medicinal pursuant to sentence 1 of the whereabouts. The certificates are to be kept in the cases of the set of 2 by the time of their receipt, in the cases of the set of 3 by the time of their creation to at least five years and to submit to the competent authority upon request.
(2) paragraph 1 does not apply to persons who acquire drug only to the application in the animals held by them and according to § 1 subject to proof.

Article 4 any person within the meaning of § 97 paragraph 2 No. 31 of the German medicines Act is, who intentionally or negligently 1 contrary to section 1, paragraph 1, sentence 1 or § 3, paragraph 1, sentence 1, incorrectly or not completely leads a proof, 2. Despite section 1, subsection 1, sentence 2 or § 3 paragraph 1 sentence 4 kept a proof not or at least five years or not or not timely submit or 3. contrary to § 2 sentence 1 an application not , documented incorrectly or not in a timely manner or not, not properly or not timely document.