To Amend The Veterinary Antibiotics Mengenströmevo, Pharmacy Regulations 2005 And Veterinarian List And Ausweisvo

Original Language Title: Änderung der Veterinär-Antibiotika-MengenströmeVO, der Apothekenbetriebsordnung 2005 sowie der Tierärzteliste- und –ausweisVO

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5. Ordinary of the Federal Minister of Health, with which the Veterinary-Antibiotics-quantity strömeVO, the pharmacy operating order in 2005 as well as the Tierärzteliste-und -ausweisVO will be changed

Article 1

Ordinance of the Federal Minister for Health, with which the Veterinary-Antibiotics-quantity-flowing VO is changed

Due to § 6 (3) of the Zoonoses Act, BGBl. I n ° 128/2005, as well as Section 8 (4) 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, is being prescribed in agreement with the Federal Minister for Agriculture, Forestry, the Environment and Water Management:

The Veterinary-Antibiotics-quantity strömeVO, BGBl. II No 83/2014, shall be amended as follows:

1. In Section 5 (2), after the phrase " 1 " the word "culpable" inserted.

2. § 6 (1) reads:

" (1) The general distribution of sales is to be carried out as a full survey among manufacturers, marketing authorisation holders (depositors) and wholesalers active in Austria, and comprises the quantities sold in the following places:

1.

veterinary skin pharmacies,

2.

public pharmacies,

3.

The University of Veterinary Medicine, Vienna,

4.

Pharmacy (s) of the Austrian Federal Army,

5.

other persons entitled to pay, for which the Federal Ministry of Health is giving an ID number. "

3. In Section 7 (1), the word order shall be " 4 " through the phrase " 3 " replaced.

4. § 7 (2) reads:

" (2) The persons obliged to do so in accordance with § 60a ABO 2005 for the purpose of keeping antibiotics in their veterinary skin pharmacies in stock, or , data on the disposal of antibiotics shall be applied to the

1.

bovine, ovine, porcine and caprine animals and

2.

other ruminants, floats, birds, poultry, rabbits and aquaculture animals, provided that they are intended for the production of food or other products intended for use on or in human beings,

to the implementing body. "

5. In § 9 (2), after the word "Dataset Descriptions" the phrase " according to the provisions of the Data Protection Act 2000, BGBl. I n ° 165/1999, in the version of the Federal Law BGBl. I No 83/2013, " inserted.

6. § 9 (3) reads:

" (3) Weiters must be in a position to be able to supply all the reporting requirements of a veterinarian. to receive, process and forward as an annual report to a veterinarian the same animal species and, at the same time, to act as a recognised reporting body within the meaning of Section 7 for the species concerned. In the case of such data transfers in accordance with Section 7 (2) (mandatory reporting by veterinarians), Bündler must be able to record the data records as soon as the data has been extended to the data after the data has been received. Annex 3 , and to generate the annual report in accordance with § 7 (2) and to send it to the responsible body from the data transfers entered in the course of the collection period. "

7. In accordance with § 9 (3), the following paragraph 3a is inserted:

" (3a) In case of the use of a bundler for the transmission of statutory declarations according to § 7, the obligation of § 7 of the veterinarian shall apply. of the veterinarian in respect of the species concerned. "

8. In accordance with § 10 (3), the following paragraph 4 is added:

" (4) § 5 (2), § 6 (1), § 7 (1) and (2), § 9 (2), (3) and (3a) and Annex 2 in the version BGBl. II No. 5/2016 will be 1. Jänner 2016 in force. "

9. Annex 2 is:

" Annex 2

Data from the sales companies

Field name

Format

Obligation

Description

Reporting Year

Number

Yes

Period of delivery (calendar year)

Type of message

Catalog

Yes

Type of message: "Sale"

Company Book Number *

Text

Yes

Company directory number of the sales company

Company name

Text

No

Name of the sales company

Hapo_Id**

Text

Yes

The identification number of the veterinary skin pharmacies to which the proprietary medicinal product has been issued OR the ID number assigned to the public pharmacies and other persons entitled to the right of reference by the BMG to which the proprietary medicinal product has been issued.

Marketing authorisation number * **

Text

Yes

Marketing authorisation number of the proprietary medicinal product

Package size

Number

Yes

Pack size with respect to the pack unit

Unit of pack size

Catalog

Yes

Unit of pack size of proprietary medicinal product sold (e.g. B. in "ml", "l", "g", "kg", "stk")

Annual total in packs

Number

Yes

Annual total of packages sold

* Format of the company's book number: FN [space] [up to six digits] [checkletter]

** Maintenance of the list by ÖTK

*** in accordance with the published list (s) of the competent authority "

Article 2

Ordinance of the Federal Minister for Health, with which the pharmacy operating order 2005 will be amended

Due to § 62a of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. No. 162/2013, and § § 7 (1) and (2), 24 (5), 31 (4), 34 (2), 38 and 60 (3) of the Pharmacies Act, RGBl. No. 5/1907, as last amended by the Federal Act BGBl. I No 32/2014, shall be arranged:

The pharmacies operating order 2005-ABO 2005, BGBl. II No 65/2005, as last amended by BGBl. II No 83/2014, shall be amended as follows:

1. The rate of introduction of Section 60a (1) reads as follows:

"The veterinarian has to keep electronic records on the relation of medicinal products and magistral preparations and, in doing so, to record the following information:"

§ 60a (3) first sentence reads as follows:

" The veterinarian has on the delivery of veterinary medicinal products containing antibiotic active substances and in accordance with the provisions of the Veterinary Medicinal Product Control Act (TAKG), BGBl. I n ° 28/2002, in the version of the Federal Law BGBl. I n ° 36/2008,-with the exception of Section 4b of the TAKG-to keep electronic records. "

3. The introduction of § 60a (4) reads as follows:

" For medicinal products which are not covered by paragraph 3 and have been delivered in accordance with the provisions of the TAKG-with the exception of § 4b TAKG-and for magistral preparations, the veterinarian has to keep electronic records, the following: Have included information: "

4. § 60a (4) Z 2 reads:

" 2. Recipient of the medicinal product (LFBIS number or VIS registration number, if any), "

5. In accordance with § 79 (9), the following paragraph 10 is added:

" (10) § 60a (1), (3) and (4) in the version BGBl. II No. 5/2016 will be 1. Jänner 2016 in force. "

Article 3

Ordinance of the Federal Minister for Health, with which the Tierärzteliste-und -ausweisVO is changed

Pursuant to § § 5 (6), 6 (2), 10 (1) and (2) and § 73 of the Veterinary Act, Federal Law Gazette (BGBl). No. 16/1975, as last amended by the Federal Act BGBl. I No 80/2013, shall be arranged:

The Tierärzteliste-und -ausweisVO, BGBl. II No 421/2012, as last amended by BGBl. II No 83/2014, shall be amended as follows:

1. § 6a (1) last sentence reads:

" The records are according to the record description of the Annex 1 Pkt. 1.1. to be established and to be kept five years after the registration of the relevant skin mortgage. "

(2) The following sentence shall be added to Article 6a (3):

" This list shall also have all the records referred to in paragraph 1 of the last sentence before the entry into force of this Regulation in the version of the BGBl. II No 5/2016, but only within a period of one year from the date of their logout. "

3. § 7 (2) reads:

" (2) Each veterinarian has a ID number, which is ident with the veterinary surgeon, and contains at least the following information:

1.

the pros and surnames,

2.

the academic degree/degrees,

3.

birth date and place of birth,

4.

nationality,

5.

the professional title of "vet"/"veterinarian"-a specialist veterinary title (§ 1 Z 13) may be entered in addition-,

6.

the date of issue,

7.

the signature,

8.

the photograph. "

4. In accordance with § 7, the following § 7a is inserted:

" § 7a. (1) The board shall be allowed to issue the veterinarian cards as a card on a plastic basis in derogation from § 7 (1). The external characteristics of the carrier material of such a veterinary certificate shall be in accordance with the ISO 7810 standard.

(2) The veterinary certificate referred to in paragraph 1 shall contain at least the following information:

1.

the imprint "Österreichische Tierärztekammer", "Austrian Chamber of Veterinary Surgeons", "Tierärzteausweis",

2.

the ID number, the ident is with the veterinarian number,

3.

the pros and surnames,

4.

the academic degree/degrees,

5.

birth date and place of birth,

6.

nationality,

7.

the professional title of "vet"/"veterinarian"-a specialist veterinary title (§ 1 Z 13) may be entered in addition-,

8.

the date of issue,

9.

the signature,

10.

the photograph.

(3) The further development of the identity card shall be carried out by the Chamber in the transferred sphere of action by means of a decision of the Assembly of Delegates. A sample is to be published on the homepage of the Tierärztekammer-after obtaining the consent of the Federal Minister of Health.

(4) The provisions of Section 7 (4) to (7) shall apply mutagenally to the veterinarians issued in accordance with paragraph 1 above. "

5. § 8 is added in accordance with section 5 of the following paragraph 6:

" (6) § 6a (1) and (3), § 7 (2) and § 7a in the version BGBl. II No. 5/2016 will be 1. Jänner 2016 in force. "

Oberhauser