Veterinary Antibiotics Mengenströmevo And Change The 2005 Pharmacy Operational Rules And The Regulation On The Establishment And Maintenance Of Vet List

Original Language Title: Veterinär-Antibiotika-MengenströmeVO sowie Änderung der Apothekenbetriebsordnung 2005 und der Verordnung über die Einrichtung und Führung der Tierärzteliste

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Regulation of the Federal Minister of Health, which establishes a system for the supervision of the distribution and consumption of antibiotics in the veterinary field (Veterinary-antibiotics-quantitative strömeVO), as well as the pharmacy operating order in 2005 and the Regulation on the establishment and management of the veterinary list of animals shall be amended

Article 1

Regulation of the Federal Minister of Health, which establishes a system for the monitoring of the distribution and consumption of antibiotics in the veterinary field (Veterinary-antibiotics-quantity-flow VO)

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:

Section 1

General provisions

Subject matter and scope

§ 1. (1) This Regulation provides the legal basis for a system for the recording of the distribution and consumption of antibiotics in the veterinary field in Austria.

(2) The aim of this Regulation is to collect the antibiotic seeds available in the veterinary field.

Definitions

§ 2. For the purposes of this Regulation:

1.

Antibiotics: antimicrobially active substances placed on the market as veterinary medicinal products in the form of authorised proprietary medicinal products, and which are listed in the ATCvet (Anatomical Therapeutic Chemical) system for the classification of veterinary medicinal products under listed QA (Alimentary tract and metabolism), QD (Dermatologicals), QG (Antiinfectives and Antiseptics), QJ (Antiinfectives for systemic use) and QP51AG (Antiparasitic products, Antiinsecticides and Repellents) codes;

2.

The Austrian Agency for Health and Food Safety (AGES) is the leading agency for the Austrian Agency for Health and Food Safety.

Data transfer, veterinary medicinal product data set

§ 3. (1) The data shall be transmitted electronically by the natural and legal persons obligated for this purpose (§ § 6 and 7) of the transmitting body using a defined data format (message). The leading position shall receive the notifications. A transfer of personal data to third parties is prohibited, except for the purpose of administrative control.

(2) In the event of corrections to the transmission referred to in paragraph 1, the notification shall be re-transmitted up to the date specified in § 5. In this case, only the most recently received message applies, all messages previously sent for the affected detection period lose their validity.

(3) The implementing body shall provide the following electronic means for the notifications:

1.

the description of the data format required for data transmission (but not the interface itself); and

2.

the type of data transmission.

(4) In order to ensure a uniform transmission of data, an electronically callable daily veterinary medicinal product data set according to Annex 1 to the public.

(5) The competent authority shall ensure the topicality of the veterinary medicinal product data set referred to in paragraph 4.

Data Validation

§ 4. (1) The evaluation of the data transmitted shall be carried out by the competent authority.

(2) The report on the evaluation of the data shall be submitted by the competent authority to the Federal Minister of Health. The results of this report will be published by the Federal Minister of Health on the homepage of the Federal Ministry of Health.

Deadlines and sanctions

§ 5. (1) The natural and legal persons obligated for transmission (§ § 6 and 7) shall ensure that the reporting obligations arising in a calendar year are complied with until 31 March of the following calendar year and up to this The time the messages arrive at the point in which they were carried out.

(2) Any person who does not comply with the reporting requirements in accordance with paragraph 1, or who does not comply with the requirements in time, is in breach of Section 8 (4) of the Veterinary Medicinal Product Control Act (TAKG), BGBl. I n ° 28/2002, as last amended by the Federal Law BGBl. I n ° 36/2008, which is to be punished in accordance with Section 13 (1) Z 10 of the TAKG.

(3) Non-compliance with the reporting obligation pursuant to § § 6 and 7 shall be reported by the competent authority to the competent authority.

Section 2

Reporting obligations

Obligations of distribution

§ 6. (1) The distribution of sales representatives is to be carried out as a full survey among manufacturers, marketing authorisation holders (depositors) and wholesalers active in Austria. A list of these natural or legal persons is always kept up-to-date by the Federal Minister of Health and published in the "Official Veterinary Messages".

(2) The collection period shall contain the previous calendar year in full. The quantities of sales are to be recorded once a year according to the procedure published by the Federal Minister for Health in the "Official Veterinary News".

(3) The notifications shall be made in accordance with the Annex 2 to format specified records.

(4) The quality control of data transmitted by manufacturers, marketing authorisation holders (depositors) and wholesalers operating in Austria and the data evaluation for the distribution of antibiotics in Austria has been carried out by the to be carried out.

(5) The return of the data from the sales data collection to the EMA has to be made by the through-leading position.

Obligations hausapothekenLeading veterinary surgeons and veterinarians

§ 7. (1) The monitoring of the consumption of antibiotics has been carried out using the data collected in accordance with § 60a (4) of the pharmacies operating regulations 2005-ABO 2005, BGBl. II No 65/2005, as last amended by BGBl. II No 83/2014, to be recorded electronically by veterinary surgeons and veterinarians of the skin.

(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 , have data on the release of antibiotics for use in animals, which are in § 1 of the 1. Animal welfare regulation, BGBl. II No 285/2004, as last amended by BGBl. II No 61/2012, are to be made available to the implementing body.

(3) The collection period shall contain the previous calendar year in full. The quantities are to be recorded once a year in accordance with the procedure published by the Federal Minister for Health in the "Official Veterinary Messages" and in compliance with the period laid down in § 5 (1), using the data set out in Annex 3 shall be transmitted electronically to the competent authority in the specified data format.

(4) For the transmission of notifications pursuant to paragraph 2, veterinarians and veterinarians of recognised hotlines may be able to use them. The Federal Minister for Health shall be able to designate such hotlines as recognised hotlines by means of a presentation in the "Official Veterinary Messages", if this is in accordance with the principles of the expediency and convenience of the notification procedure and the reporting bodies fulfil the conditions laid down in paragraph 5. Veterinarians who make use of this option must make a written commitment to the Reporting Office to ensure that all notifications pursuant to paragraph 2 are reported via this reporting body, without prejudice to the provisions of § 9.

(5) Recognised hotlines must have a plausibility check of the data to be reported and have access to the reporting of functioning electronic interfaces by which the data will be sent to the leading body in accordance with the requirements of the Annex 3 shall be forwarded. A publication as a recognised reporting body requires the existence of these possibilities as well as the successful completion of a test run for checking the interface (transmission of a sample data record to the lead-through location). If these possibilities are no longer available, the recognition shall be issued. The deletion of the recognition shall be published by the Federal Minister of Health in the "Official Veterinary Messages".

Section 3

Voluntary reports

Voluntary reports

§ 8. (1) The following data may be collected and transmitted to the implementing body for the better readability and availability of the antibiotics used in the single animal, in addition to the reports of the second section of this Regulation:

1.

Data on the use of antibiotics by the animal keeper or by the keeper,

2.

Data on the use of antibiotics by the veterinarian by the veterinarian.

(2) The period of collection of voluntary notifications shall include the full previous calendar year. The notifications shall be sent to the responsible body by 31 March of the following year.

Bundlers

§ 9. (1) For the transmission of notifications in accordance with § 8, animal keepers and veterinarians of so-called "Bündler" have to be served. The Federal Minister for Health may designate such bodies as a grouping by means of the presentation of the "Official Veterinary Messages", if this is in accordance with the principles of appropriateness and convenience of the notification procedure and if the reporting bodies are responsible for the The requirements of Section 2 and Section 7 (5) are fulfilled. Veterinarians who make use of this option must make a written commitment to the Bündler that all notifications in accordance with § 8-in the case of animal-specific bundlers all notifications of the species concerned-via this Bundlers are reported.

(2) Graubündeners need to be more plausible for data to be reported and for the reporting of functioning electronic interfaces, via which the data is available in compliance with the data set out in Annex 4 shall be communicated to the agency in full anonymized form.

(3) Weiters must be able to receive all notifications from a veterinarian, or of a veterinarian, the same animal species as set out in the Annex 3 and, at the same time, to act as a recognised reporting body within the meaning of Section 7 for the species concerned. In case of use of the bundler for the transmission of mandatory reports in accordance with § 7, the obligation of § 7 with regard to the animal species concerned is deemed to be fulfilled.

(4) A publication as a bundler requires the existence of these possibilities as well as the successful completion of a test run for checking the interface (transmission of a sample data record to the lead-through location). If these possibilities are no longer available, the recognition shall be issued. The deletion of the recognition shall be published by the Federal Minister of Health in the "Official Veterinary Messages".

Section 4

Final provisions

Entry into force and transitional provisions

§ 10. (1) This Regulation shall enter into force on 15 April 2014.

(2) The first annual report according to § 6 shall be made until 31 March 2015 for the collection period 2014.

(3) The first-time annual report pursuant to § 7 shall be made until 31 March 2016 for the collection period 2015.

Annex 1

1.1. Veterinary medicinal product

Note: The detailed technical specification is published on the home page of the implementing body.

1.1.1. Data fields provided by veterinaetitibiotics

Field name

Obligation

Format

Description

Approval number

Yes

Text

Marketing authorisation number of the proprietary medicinal product

Label

Yes

Text

Name of the proprietary medicinal product

Pharmaceutical Form

Yes

Text

Pharmaceutical speciality pharmaceutical form

Marketing authorisation holder

Yes

Text

Organization name of the marketing authorisation holder of the proprietary medicinal product

Sales Company

No

Text

Organization name of the sales company of the drug speciality

Status

Yes

Text

Status of drug speciality

Status Date

Yes

Date

Date of the status of the proprietary medicinal product
Note: If the proprietary medicinal product is approved, the date of first admission is indicated. If the drug speciality is lifted, the lifting date is displayed

ATCvet Code

Yes

Text

ATCvet code of the proprietary medicinal product

Submittal Status

Yes

Text

Delivery status of the proprietary medicinal product

Application Device

Yes

Catalog

Smallest unit of drug speciality to be used in "ml", "l", "g", "kg", "stk"

Package size

Yes

Number

Pack size of the proprietary medicinal product (referred to the pack unit)

Unit of package

Yes

Catalog

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

Animal species

Yes

Catalog

Bsp.: "Rind", "Schwein", etc.

Application type

Yes

Text

Indication

No

Text

Use indication

Active substance

Yes

Text

Active substance of the proprietary medicinal product

add

Yes

Number

Animal Daily Dose in mg/GVE

Minimum dosage

No

Number

Minimum dosage

Maximum dosage

No

Number

Maximum dosage

Unit of dosing

No

Catalog

Unit of dosing

Minimum application duration

No

Number

Minimum application duration

Maximum application duration

No

Number

Maximum application duration

Application Duration Unit

No

Catalog

Application Duration Unit

pdd

No

Number

Prescribed Daily Dose in mg/GVE

Target tissue

No

Text

Bsp.: "Edible tissue", "Milk"

Dosage

No

Text

Wait Time

No

Number

Wait Time Unit

No

Catalog

Wait Time Unit

Special feature (waiting time)

No

Text

Description of peculiarities in waiting times

Active substance

No

Text

Name of the active substance of the proprietary medicinal product

Active substance content of

No

Number

Active substance content of the active substance per application unit

Active substance content up to

No

Number

Active substance content of the active substance per application unit

Unit of active substance content

No

Catalog

Unit of active substance content

Subject Information

No

Text

Link to the valid specialist information

Package leaflet

No

Text

Link to the valid leaflet for use

Antibiotics Mass Flow Regulation

No

Boolean

1.1.2. Data fields provided by veterinary medicinal products (excluding veterinary medicinal products)

Field name

Obligation

Format

Description

Approval number

Yes

Text

Marketing authorisation number of the proprietary medicinal product

Label

Yes

Text

Name of the proprietary medicinal product

Pharmaceutical Form

Yes

Text

Pharmaceutical speciality pharmaceutical form

Marketing authorisation holder

Yes

Text

Organization name of the marketing authorisation holder of the proprietary medicinal product

Sales Company

No

Text

Organization name of the sales company of the drug speciality

Status

Yes

Text

Status of drug speciality

Status Date

Yes

Date

Date of the status of the proprietary medicinal product
Note: If the proprietary medicinal product is approved, the date of first admission is indicated. If the drug speciality is lifted, the lifting date is displayed

ATCvet Code

Yes

Text

ATCvet code of the proprietary medicinal product

Submittal Status

Yes

Text

Delivery status of the proprietary medicinal product

Application Device

Yes

Catalog

Smallest unit of drug speciality to be used in "ml", "l", "g", "kg", "stk"

Package size

Yes

Text

Pack size of the proprietary medicinal product (referred to the pack unit)

Unit of package

Yes

Text

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

Animal species

Yes

Catalog

Bsp.: "Rind", "Schwein", etc.

Application type

Yes

Text

Target tissue

No

Text

Bsp.: "Edible tissue", "Milk"

Dosage

No

Text

Wait Time

No

Number

Wait Time Unit

No

Catalog

Wait Time Unit

Special feature (waiting time)

No

Text

Description of peculiarities in waiting times

Subject Information

No

Text

Link to the valid specialist information

Package leaflet

No

Text

Link to the valid leaflet for use

Antibiotics Mass Flow Regulation

No

Boolean

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

Identification number of the veterinary skin pharmacist to which the proprietary medicinal product has been delivered

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 the pack size of the proprietary medicinal product sold (e.g. 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

Annex 3

Data of the delivery quantities

Field name

Obligation

Format

Description

MelderID

Yes

Text

ID of the veterinarian skin pharmacist or the authorized body

Reporting Year

Yes

Number

Period of delivery (calendar year)

Type of message * *

Yes

Catalog

"Application to the application"

Hapo_Id *

Yes

Text

Identification number of the veterinarian's home pharmacy

LFBIS

Yes

Text

Operating number (LFBIS)-if not available VIS-registration number-the company on which the drug speciality has been handed over

Marketing authorisation number * *

Yes

Text

Marketing authorisation number of the proprietary medicinal product

Animal species * *

Yes

Catalog

Species to be selected: "Rind", "Schwein", "Huhn", "Pferd", "Fisch", "Schaf", "Ziege", etc.

Type of use * *

Yes

Catalog

Entry to be selected: "mast", "breeding", "milk", "laying hens", "parent animals", "mixed", etc.

Annual amount of the quantity delivered

Yes

Number

Annual sum of the quantity delivered in the application unit

Application Device

Yes

Catalog

Smallest unit to be applied in "ml", "l", "g", "kg", "stk"

* Maintenance of the list by ÖTK

** in accordance with the published list (s) of the

Annex 4

Volunteer Part: Application Data

Field name

Obligation

Format

Description

MelderID

Yes

Text

ID of the veterinarian or LFBIS of the company, if not available VIS registration number or ID of the bundler

Reporting Year

Yes

Number

Calendar year of application

Type of message *

Yes

Catalog

"Application"

Application by TA

Yes

Boolean

Use by veterinarian yes/no

Date

Yes

Date

Date of application in DD.MM.YYYY format

ID of the veterinarian

No

Text

Veterinarian ID

LFBIS

Yes

Text

Operating number (LFBIS)-if not available, VIS-registration number-the operation on which the proprietary medicinal product has been applied

Marketing authorisation number *

Yes

Text

Marketing authorisation number of the proprietary medicinal product

Animal species *

Yes

Catalog

animal species to be selected: "beef", "pig", ... etc.

Usage type *

Yes

Catalog

Animal tags

Yes

Text

Rind: ear tag number

Pigs or chickens: herds, stables or coves

Total Daily Amount

Yes

Number

the amount used in the application period

Application Device *

Yes

Catalog

Smallest unit to be applied in "ml", "l", "g", "kg", "stk"

Number of animals treated

Yes

Text

Number of animals treated

Diagnostic code *

Yes

Catalog

Application duration (in days)

Yes

Text

application or period of application specified on the submission document

Batch number

No

Text

Charge of the proprietary medicinal product

HAPO_ID **

No

Text

Identification number of the veterinarian's home pharmacy

* according to the published list (s) of the passage

** Maintenance of the list by ÖTK

Article 2

Ordinance of the Federal Minister of Health, which changes the pharmacies operating order in 2005

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 80/2013, shall be arranged:

The pharmacies operating order 2005-ABO 2005, BGBl. II No 65/2005, as last amended by BGBl. II No 474/2010, shall be amended as follows:

1. § The following paragraph 1a is inserted after 60 (1):

" (1a) On the occasion of the opening of a veterinary skin pharmacist, the District Administrative Authority for the Office of the Hausapotheke has a location number according to the requirements of: Annex 1 Pkt. 1.2.1. of the Regulation on the establishment and management of the veterinary list and the list of veterinary surgeons and veterinary surgeons, as well as on the form and content of the veterinary certificate (Tierärzteliste und -ausweisVO), BGBl. II No 421/2012, as last amended by BGBl. II No 83/2014, and attach the location number generated in this way to the Austrian Veterinary Chamber on the ad referred to in paragraph 1 above. "

2. § 60 (9) to (11).

3. In accordance with § 60, the following § 60a is inserted:

" Recording requirements for veterinary skin pharmacies

§ 60a. (1) The veterinarian has to keep electronic records on the purchase of medicinal products and, in doing so, to record the following information:

1.

delivery date,

2.

the quantity received,

3.

Name and address of supplier

4.

the name of the medicinal product, and

5.

in the case of proprietary medicinal products batch number or

6.

in the case of magistral preparations, the date of manufacture.

(2) The veterinarian has to keep electronic records of the confirmations in accordance with § 60 (3) and (4) of the electronic records, from which

1.

the date of manufacture,

2.

the type and quantity of ingredients;

3.

the type of manufacture and

4.

the duration of the applicability (expiration date)

can be determined.

(3) The veterinarian is responsible for the delivery of veterinary medicinal products containing antibiotic active substances and in accordance with the provisions 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,-with the exception of Section 4b of the TAKG, which does not apply to equidae-have been given electronic records. The records have been recorded in accordance with the requirements of the Annex 1 shall be directed.

(4) For medicinal products which are not covered by paragraph 3 and have been submitted in accordance with the provisions of the TAKG, with the exception of § 4b TAKG, which is not applicable here for equidae, the veterinarian has to keep records of electronic records which: have included the following information:

1.

the date of delivery,

2.

Recipient of the medicinal product (LFBIS number or VIS registration number),

3.

the marketing authorisation number of the medicinal product and

4.

the quantity delivered.

(5) The records referred to in paragraphs 1 to 4 shall be kept by means of electronic data processing, ensuring that the data are available during the retention period in the veterinarian's home pharmacy.

(6) Veterinary/veterinary surgeons who are obliged to maintain electronic records in accordance with paragraph 3 of this Regulation shall have one in accordance with the Veterinary Antibiotics Quantity strömeVO, BGBl. II no. 83/2014, the electronic interface, the establishment and operation of which are used by the hospital-leading veterinarian and/or the veterinarian of the skin's pharmacist. "

(4) The following paragraphs 7 to 9 are added to § 78:

" (7) § 60 (1a) and Annex 1 in the version of the BGBl. II No. 83/2014 will enter into force on 15 April 2014. The site number will be transmitted by the Federal Minister of Health to the Austrian Veterinary Chamber for veterinary skin pharmacies, which are already registered with the Austrian Veterinary Chamber until 14 April 2014.

(8) § 60a in the version of the BGBl. II No. 83/2014 shall enter into force on 15 April 2014, with the expiry of 14 April 2014, Section 60 (9) to (11) shall expire.

(9) The obligation to maintain electronic records in accordance with § 60a shall be made with 1. Jänner 2019. "

5. The Regulation shall be: Annex 1 attached:

" Annex 1

Data of the dispensing quantities of veterinary skin pharmacies

Field name

Format

Description

Date

Date

Date of submission in the format DD.MM.YYYY

Hapo_Id *

Text

Identification number of the veterinarian's home pharmacy

LFBIS

Text

Operating number (LFBIS)-if not available, VIS-registration number of the holding-the company on which the drug application/delivery has been made

Marketing authorisation number * *

Text

Marketing authorisation number of the proprietary medicinal product

Animal species * *

Catalog

Animal species to be selected: "bovine", "pig", "poultry", "horse", "fish", "sheep", "goat", etc.

Usage Type

Catalog

Entry to be selected: "mast", "breeding", "milk", "laying hen", "parent animal", mixed, etc.

Quantity

Number

specified amount in the application unit

Application Device

Text

Smallest unit to be applied in "ml", "l", "g", "kg", "stk"

* Maintenance of the list by ÖTK

** in accordance with the published list (s) of the leading position "

Article 3

Regulation of the Federal Minister of Health, amending the Regulation on the establishment and management of the veterinary list and on the form and content of the veterinarian's card

Pursuant to § § 5 (6), 6 (2), 10 (1) and (2), 13a and 73 of the Tierärztegesetz, BGBl. No. 16/1975, as last amended by the Federal Act BGBl. I No 80/2013, shall be arranged:

The regulation on the establishment and management of the veterinary list and on the form and content of the veterinary certificate, BGBl. II No 421/2012, shall be amended as follows:

1. The title of the Regulation is: