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259. Ordinance of the Federal Minister of Health on the application of veterinary medicinal products with the involvement of the animal holder (Veterinary medicinal products-Application Regulation 2010)
On the basis of Section 7 (1) of the Veterinary Medicinal Products Control Act (TAKG), BGBl. I n ° 28/2002, as last amended by the Federal Law BGBl. I n ° 36/2008 and the Federal Law BGBl. I No 3/2009, shall be ordered:
Principle of medicinal product use
§ 1. The involvement of the keeper in the use of veterinary medicinal products (veterinary medicinal products) may be carried out by the veterinarian only in accordance with § § 20 and 21 of the Veterinary Act, BGBl. No. 16/1975, as last amended by the Federal Act BGBl. I n ° 135/2006 and the Federal Law BGBl. I No 3/2009, to the extent strictly necessary and in accordance with the provisions of this Regulation.
Release of veterinary medicinal products for delivery to animal keepers
§ 2. (1) Veterinary proprietary medicinal products which are suitable in accordance with the following provisions to be delivered to animal keepers may be released by the Federal Minister of Health, taking into account the following conditions:
1. |
they contain only pharmacologically active substances which are listed in Table 1 of the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification as regards maximum residue limits in foodstuffs of animal origin, OJ L 327, 28.12.2010, p. No. OJ L 15, 20.1.2010, p. |
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2. |
they are approved in Austria; and |
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3. |
there must be no animal health or technical concerns in respect of release; and |
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4. |
the surrender to the keeper is not prohibited under EU law; and |
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5. |
the application may not be reserved exclusively to the veterinarian in accordance with specialist information. |
(2) The release of the veterinary medicinal products shall be made by means of the presentation in the Official Veterinary News (AVN) and shall be effective on the first day of the following month.
(3) The release shall be revoked if one of the conditions set out in paragraph 1 is not or no longer exists. The revocation shall be made by the customer in the AVN and shall be effective with the first day of the following month.
(4) Homöopathic proprietary medicinal products shall be withdrawn from the requirement of release as referred to in paragraph 1.
Submission of veterinary medicinal products to animal keepers
§ 3. (1) Within the framework of an animal health service pursuant to section 7 (2) of the TAKG as well as in accordance with § 12 and § 24 (3) of the Tierärztegesetz (Tierärztegesetz), the veterinarian may, in the course of a treatment or for follow-up treatment, be allowed to use the animal holder for oral administration to animals or to external use of veterinary medicinal products, which are
1. |
in accordance with § 2, and |
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2. |
are marked "NE" in the column "levy" of the customer pursuant to § 2 (2). |
(2) Likewise, homeopathic proprietary medicinal products intended for oral or external administration may be left to the animal keeper by the veterinarian.
(3) The veterinarian may not be responsible for the animal keepers, who are not in accordance with the Animal Health Service Regulation 2009 (TGD-VO 2009), BGBl. II No 434, belong to the approved Animal Health Service (TGD), the medicinal products referred to in paragraphs 1 and 2 of this Article are to be delivered only in a quantity required for the success of the treatment in question, but not more than the monthly requirement. In the case of externally applicable preparations for combating parasites, the delivery quantity can be determined for the duration of a treatment cycle, even if the monthly requirement is exceeded.
(4) The veterinarian has to inform the keeper of the necessary storage conditions of the veterinary medicinal products issued.
Feedingstuffs-Premixtures
§ 4. Pre-mixes may only be delivered to livestock keepers if the provisions of § 6 TAKG are fulfilled.
Delivery of veterinary medicinal products in the animal health service
§ 5. (1) As part of an animal health service according to § 7 para. 2 of the TAKG, veterinary medicinal products may, in addition to the provisions of § § 3 and 4, be used in the context of a treatment or for follow-up treatment to the TGD-drug user for oral administration. Animals or groups of animals or groups of animals or groups of animals acutely affected by animals or groups of animals according to § 2 Z 4 TGD-VO 2009 shall be left to the animal for subcutaneous, intramuscular, intranasal and intramammary use, the animals being treated with
1. |
in accordance with § 2, and |
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2. |
In the column "levy" of the customer according to § 2 para. 2 with "TGD" or "TGD-AB" are marked. |
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A levy of veterinary medicinal products marked with "TGD-AB" is only permitted on the basis of special veterinary requirements and the use must be justified by suitable objectivable diagnostic measures. In addition, the levy has to comply with the requirements of § 12 TGD-VO 2009 with regard to delivery conditions, delivery quantity and delivery deadlines. |
(2) By way of derogation from paragraph 1, a TGD drug user as a participant in an approved animal health programme in accordance with § 15 TGD-VO 2009, which has been made available in the AVN, may also be allowed to use other veterinary medicinal products for use in the application. if they are listed in the respective programme as follows:
1. |
the name of the veterinary medicinal products, |
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2. |
Marketing authorisation number of veterinary medicinal products, |
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3. |
Marketing authorisation holders of veterinary medicinal products, |
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the type and quantity of application; and |
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5. |
the explicit indication of the admissibility of the dispensing of veterinary medicinal products to the keeper of the animal. |
(3) In addition to the requirements laid down in paragraphs 1 and 2, the veterinary medicinal products referred to therein may be left to the TGD medicinal product user only if the TGD medicinal product practises the training requirements according to § 10 and Annex 4 of the TGD-VO 2009.
(4) Injectors for drying cows for cows may be delivered by the veterinarian to the TGD drug user. This also applies to injectors for drying stations, which are only provided for single use according to specialist information. Likewise, homeopathic proprietary medicinal products may be left to the TGD drug user by the veterinarian.
(5) The veterinarian has to be convinced of the possibilities of proper storage of the veterinary medicinal products delivered.
Animal vaccines
§ 6. (1) Animal vaccines may not be used for use only if they have been released for this purpose in accordance with Article 2 (1) (2) (2) (2) to (5). Existing reporting requirements in accordance with Section 12 (2) and (3) of the Animal Health Act, RGBl. No 177/1909, as last amended by the Federal Law BGBl. I n ° 36/2008, must be complied with by the veterinarian.
(2) The release for animal vaccines shall be made by the customer in the AVN and shall be effective with the first day of the following month.
(3) The release shall be revoked if any of the conditions set out in § 2 (1) (1) (2) to (5) are not or no longer exist. The revocation shall be made by the customer in the AVN and shall be effective with the first day of the following month.
(4) Where animal vaccines are administered by the treating veterinarian, this may be done only in a quantity which is necessary for the immunisation of the animals concerned in accordance with the information provided for by the specialist information, but at the most, the monthly requirement.
Delivery of veterinary medicinal products in the presence of a therapeutic otary
§ 7. (1) Veterinary medicinal products which are used by the veterinarian in accordance with § 1 (3) and § 4 (2) TAKG may only be delivered to the keeper in accordance with the following conditions:
1. |
to be provided for oral or external use in accordance with professional information and |
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2. |
they contain only pharmacologically active substances, which are listed in Table 1 of the Annex to Regulation (EU) No 37/2010, and |
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3. |
their submission to the keeper may not be prohibited by Union law, and |
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4. |
there must be no animal health or technical concerns in respect of the levy; and |
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5. |
the application may not be reserved exclusively to the veterinarian in accordance with specialist information. |
(2) The recording obligations provided for in accordance with Section 4a (1) and (2) of the TAKG shall be supplemented, if applicable, by the following records in the case of charges within the meaning of paragraph 1:
1. |
An endorsement shall be made on the delivery note stating that this veterinary medicinal product is not authorised in Austria. |
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2. |
The statement of reasons for the application and the levy of the veterinary medicinal product shall be indicated on the delivery note. |
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3. |
The waiting time shall be determined by the abating veterinarian in accordance with § 4 (5) of the TAKG. |
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4. |
The date of the reference shall be recorded and evidence of the reference (copy of the invoice, delivery note, etc.) shall be kept for at least five years. |
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5. |
If the package leaflet is not available in German, the keeper is to hand over a corresponding German-language leaflet in written form. |
Personal names
§ 8. In the case of the personal names used in this Regulation, the chosen form shall apply to both sexes.
References
§ 9. To the extent that this Regulation refers to other federal laws or regulations, or to provisions in European Union (EU) regulations, these are to be applied in their respective versions.
Transitional provisions
§ 10. Veterinary medicinal products, according to the Veterinary Proprietary Medicinal Products-Application Regulation, BGBl. II No 266/2006, to the keeper of animals, even if their tax is no longer permitted under this Regulation, until 30 September 2010, veterinary medicinal products for combating parasites up to the end of the expiry of the period of expiry of the of the treatment period.
In-force pedals
§ 11. (1) This Regulation shall enter into force on 1 September 2010.
(2) With the expiry of 31 August 2010, the Veterinary Proprietary Medicinal Product-Application Regulation, BGBl. II No 266/2006, except for force.
Stöger