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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Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2014_II_83/BGBLA_2014_II_83.html

83. Regulation of the Federal Minister for health, which establishes a system for monitoring the distribution and consumption of antibiotics in veterinary (veterinary antibiotics MengenströmeVO) as well as the pharmacy operating regulations 2005 and the regulation on the establishment and maintenance of vet list be changed

Article 1

Ordinance of the Federal Minister for health, which establishes a system for the monitoring of the distribution and consumption of antibiotics in veterinary (veterinary antibiotics MengenströmeVO)

On the basis of article 6 par. 3 of the zoonotic Act, Federal Law Gazette I no. 128/2005, as well as § 8 para 4 of the animal medicines Control Act (TAKG), Federal Law Gazette I no. 28/2002, I no. 36/2008, will be amended by the Federal Act Federal Law Gazette in agreement with the Federal Minister of agriculture and forestry, environmental and water management:

1 section

General terms and conditions

Subject matter and scope

The legal basis § 1 (1) this regulation provides for a system for the collection of the sales and consumption of antibiotics in the veterinary field in Austria.

(2) the objective of this regulation is the acquisition of the Antibiotikamengen given in the veterinary field.

Definitions

§ 2. For the purposes of this Regulation:



1. antibiotics: antimicrobial active substances, which are placed in the form of approved medicinal products as veterinary medicinal products on the market and in the ATCvet (anatomical therapeutic chemical) classification system of veterinary medicinal product under the code QA (alimentary tract and metabolism), QG (antiinfectives and antiseptics), QD (Dermatologicals) and QJ (antiinfectives for systemic use) and QP51AG (antiparasitic products, Antiinsecticides and repellents) are listed.

2. organising authority: the Austrian Agency for health and food security GmbH (AGES).

Data transfer, animal medicines record

The data are § 3 (1) to deliver (message) electronically by the natural and legal persons, debtor (articles 6 and 7) of the operating point using a custom data format. The implementing body is to accept messages. A transfer of personal data to third parties is prohibited, except for the purpose of regulatory control.

(2) in the case of corrections of transmission referred to in paragraph 1, the message is until the date referred to in paragraph 5 to send. Only the last received message applies in this case, all messages previously sent to the affected data entry period will expire.

(3) the implementing agency has the messages electronically to to provide the following:



1. the necessary for the transmission of data description of the data format (but not the interface itself), and 2. the type of data transmission.

(4) in order to ensure a uniform data transfer, an electronically searchable, daily updated animal medicines record in accordance with Annex 1 to to provide is by the implementing body.

(5) the implementing agency shall ensure the freshness of the animal drug record referred to in paragraph 4.

Data evaluation

§ 4 (1) is the evaluation of the submitted data to carry out by the implementing agency.

(2) the report on the evaluation of the data is to provide the Federal Minister of health by the implementing agency. The results of this report will be published by the Federal Minister of health on the homepage of the Federal Ministry of health.

Time limits and sanctions

5. (1) the natural or legal persons committed to the delivery (articles 6 and 7) have to ensure that met the reporting obligations incurred in a calendar year to March 31 of the following calendar year and up to this point, the messages to the implementing body have arrived.

(2) a person who does not or not timely comply with the reporting obligations referred to in paragraph 1, commits a violation of § 8 para 4 of the animal medicines Control Act (TAKG), Federal Law Gazette I no. 28/2002, as last amended by Federal Law Gazette I no. 36/2008, which can be punished 10 TAKG Z according to article 13, paragraph 1.

(3) failure to comply with the reporting duties in accordance with articles 6 and 7 must be reported by the implementing agency to the competent authority.

2. section

Reporting obligations

Obligations of distribution

Section 6 (1) is the creation of sales quantities as making census manufacturers operating in Austria, marketing authorisation holders (Depositeuren) and pharmaceutical wholesalers. A list of natural or legal persons will be held by the Federal Minister for health always up to date and published in the "official veterinary news".

(2) the data entry period has each fully to contain the previous calendar year. The sales quantities are once a year after the Federal Minister for health in the "official veterinary news" published procedure to capture.

(3) the messages are for formatting the data rates listed in Appendix 2.

(4) the quality control of the data reported by manufacturers operating in Austria, marketing authorisation holders (Depositeuren) and drug wholesalers and the data analysis for the distribution of antibiotics in Austria has to be carried out by the implementing body.

(5) the return transmission of data from the creation of sales volumes on the EMA has to be carried out by the implementing body.

Obligations of home pharmacy leading veterinarians and animal doctors

§ 7 (1) monitoring the consumption of antibiotics has using the data, in accordance with section 60a (4) pharmacy Regulations 2005 - subscription 2005, Federal Law Gazette II No. 65/2005, II are last amended by BGBl. electronic record No. 83/2014, the Selfcare leading veterinarians and veterinarians, to be carried out.

(2) which apply 2005, committed individuals who hold antibiotics in its veterinary medicine cabinet, or submit the application according to § 60a subscription data on the distribution of antibiotics used on animals have, in section 1 of 1 animal husbandry regulation, Federal Law Gazette II No. 285 / 2004, last amended by Federal Law Gazette II No. 61 / 2012, are listed to provide the operating point.

(3) the data entry period has each fully to contain the previous calendar year. The quantities are to gather once a year after the procedure, published by the Federal Minister of health in the "official veterinary news" and to the implementing body electronically in compliance with the deadline of § 5 para 1, using the records in the specified data format described in annex 3.

(4) veterinarians and animal doctors of recognized hotlines can control to submit reports in accordance with paragraph 2. The Federal Minister of health may set in the "official veterinary news" as a recognized hotlines by proclamation such hotlines if this complies with the principles of convenience and quickness of the notification procedure and reporting bodies meet the requirements of paragraph 5. Veterinarians and animal doctors who make use of this possibility, must undertake in writing of the Registrar to all messages according to para 2 - Notwithstanding the provisions of section 9 - through this Clearinghouse to be reported.

(5) recognized hotlines need to reporting data deduplicating which further and functioning electronic interfaces have for the messages, which transmitted the data to the implementing authority in accordance with the requirements of annex 3. A publication as recognized Registrar assumes the existence of these possibilities, as well as the successful completion of a test run to check the interface (transmission of a sample data set at the operating point). These options no longer exist, the recognition will be void. The termination of recognition issued by the Federal Minister of health in the "official veterinary news".

3. section

Voluntary reports

Voluntary reports

§ 8 (1) for the better traceability and attribution of antibiotics applied to the individual can - be following data collected about the messages of the 2nd section of this regulation, and the implementing office shall:



1. data on the use of antibiotics by the Tierhalterin or by the owners, 2. data about the use of antibiotics by the veterinarian or by the veterinarian.

(2) the acquisition period of voluntary reports each has completely to contain the previous calendar year. The messages are intended to transmit up to March 31 of the following year at the operating point.

Bundler


9. (1) for the transmission of messages in accordance with § 8 have to use stockbreeders and livestock keepers and veterinarians and veterinarians of so-called Bundler. The Federal Minister of health may set in the "official veterinary news" as a coordinator by proclamation such bodies if this complies with the principles of convenience and quickness of the notification procedure and reporting bodies meet the requirements of paragraph 2 as well as article 7, par. 5. Veterinarians and animal doctors who make use of this possibility, must the Bundler agree to in writing that all messages according to § 8 - species-specific comrades all the relevant animal species - over this Bundler are reported.

(2) Bundler must deduplicating data continue to report and functioning electronic interfaces have for the messages, that the data in compliance with the data set descriptions listed in Appendix 4 are delivered anonymously at the operating point.

(3) Bundler in the location must be in addition to accept all messages of a veterinarian or a vet's same species on in accordance with the requirements of annex 3 and forward and thus at the same time to act as a recognized Registrar in the meaning of § 7 of the concerned species. For the use of the Bündlers for the transmission of mandatory messages according to § 7 obligation of article 7 with regard to the affected species is considered to be fulfilled.

(4) a publication as a Coordinator requires the existence of these possibilities, as well as the successful completion of a test run to check the interface (transmission of a sample data set at the operating point). These options no longer exist, the recognition will be void. The termination of recognition issued by the Federal Minister of health in the "official veterinary news".

4 section

Final provisions

Entry into force and transitional provisions

10. (1) effective this regulation with April 15, 2014.

(2) the first annual message has to be made until March 31, 2015 for the data entry period 2014 according to § 6.

(3) the first annual message according to § 7 to March 31, 2016 for the data entry period 2015 must be made.

 

Annex 1

1.1. animal pharmaceutical record

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

1.1.1. provided data fields of veterinary antibiotics



Field name









Duty









Format









Description









Approval number





Yes





Text





Approval of the medicinal







Description





Yes





Text





Name of the medicinal







Pharmaceutical form





Yes





Text





Pharmaceutical form of the medicinal







Marketing authorisation holder





Yes





Text





Organization name of the marketing authorisation holder of the medicinal







Sales company





No





Text





Organization name of the distribution company of the medicinal







Status





Yes





Text





Status of the medicinal







Date of status





Yes





Date





Date of the status of medicinal Note: If the medical specialty is approved, the first registration date will be shown. The medical specialty is lifted, the date of termination will be shown







ATCvet code





Yes





Text





ATCvet code of medicinal







Tax status





Yes





Text





Tax status of the medicinal







Application unit





Yes





Catalog





Smallest applicable unit of medical specialty in "ml", "l", "g", "kg", "PK"







Pack size





Yes





Number





Packaging of medicinal (related to the packing unit)







Unit of packaging





Yes





Catalog





Pack size of the medicinal unit (for example "ml", "l", "g", "kg", "PCs")







Species





Yes





Catalog





Example: "beef", "Pig", etc.







Type of application





Yes





Text





 







Indication





No





Text





Usage indication







Active ingredient





Yes





Text





The active ingredient of the medicinal







Add





Yes





Number





Animal daily dose in mg/Lu







Minimum dosage





No





Number





Minimum dosage







Maximum dosage





No





Number





Maximum dosage







Unit of dose





No





Catalog





Unit of dose







Minimum duration of application





No





Number





Minimum duration of application







Maximum application time





No





Number





Maximum application time







Unit of duration of application





No





Catalog





Unit of duration of application







PDD





No





Number





2weeks daily dose in mg/Lu







Target tissues





No





Text





Example: "edible tissues", "Milk"







Dosage





No





Text





 







Waiting time





No





Number





 







Unit of time





No





Catalog





Unit of time







Special feature (latency)





No





Text





Description of special features of waiting times







Active ingredient





No





Text





Name of the active substance of the medicinal







Active ingredient content of





No





Number





Active ingredient content of active substance per unit of application







Active ingredient content to





No





Number





Active ingredient content of active substance per unit of application







Unit of the active ingredient content





No





Catalog





Unit of the active ingredient content







Information for professionals





No





Text





Link to the valid information for professionals







Instructions for use





No





Text





Link to the valid instructions







Antibiotics electricity regulation of amounts of





No





Boolean





 





 

 

1.1.2. provided data fields of veterinary medicinal products (except veterinary antibiotics)



Field name









Duty









Format









Description









Approval number





Yes





Text





Approval of the medicinal







Description





Yes





Text





Name of the medicinal







Pharmaceutical form





Yes





Text





Pharmaceutical form of the medicinal







Marketing authorisation holder





Yes





Text





Organization name of the marketing authorisation holder of the medicinal







Sales company





No





Text





Organization name of the distribution company of the medicinal







Status





Yes





Text





Status of the medicinal







Date of status





Yes





Date





Date of the status of medicinal Note: If the medical specialty is approved, the first registration date will be shown. The medical specialty is lifted, the date of termination will be shown







ATCvet code





Yes





Text





ATCvet code of medicinal







Tax status





Yes





Text





Tax status of the medicinal







Application unit





Yes





Catalog





Smallest applicable unit of medical specialty in "ml", "l", "g", "kg", "PK"








Pack size





Yes





Text





Packaging of medicinal (related to the packing unit)







Unit of packaging





Yes





Text





Pack size of the medicinal unit (for example "ml", "l", "g", "kg", "PCs")







Species





Yes





Catalog





Example: "beef", "Pig", etc.







Type of application





Yes





Text





 







Target tissues





No





Text





Example: "edible tissues", "Milk"







Dosage





No





Text





 







Waiting time





No





Number





 







Unit of time





No





Catalog





Unit of time







Special feature (latency)





No





Text





Description of special features of waiting times







Information for professionals





No





Text





Link to the valid information for professionals







Instructions for use





No





Text





Link to the valid instructions







Antibiotics electricity regulation of amounts of





No





Boolean





 





 

 

Annex 2

Data of the distribution companies



Field name









Format









Duty









Description









Filing year





Number





Yes





Period of delivery (calendar year)







Type of message





Catalog





Yes





Type of message: 'Sale'







Company registration number *.





Text





Yes





Company book number of sales company







Business name





Text





No





Name of the distribution company







Hapo_Id *.





Text





Yes





Identification number of the veterinary medicine cabinet medicine speciality was traded to the







Registration number *.





Text





Yes





Approval of the medicinal







Pack size





Number





Yes





Pack size relative to the packaging unit







Pack size unit





Catalog





Yes





Pack size unit of sold medicinal (for example in "ml", "l", "g", "kg", "PCs")







Annual total in packs





Number





Yes





Annual total of sold packages





* Format of company registration number: FN [space] [up to six digits] [check letter]

* Maintenance of the list by ÖTK

According to the published lists of operators site

 

 

Annex 3

Data of the quantities



Field name









Duty









Format









Description









MelderID





Yes





Text





ID of the veterinary medicine cabinet or other authorized body







Filing year





Yes





Number





Period of the tax (calendar year)







Type of message *.





Yes





Catalog





"Submission to the application"







Hapo_Id *.





Yes





Text





Identification number of the veterinary medicine cabinet







LFBIS





Yes





Text





Operation number (LFBIS) - if not exists VIS registration number the operation takes place on the dispensing of the medicinal







Registration number *.





Yes





Text





Approval of the medicinal







Species *.





Yes





Catalog





To select species: "Beef", "Pig", "Chicken", "Horse", "Fish", "Sheep", "Goat", etc.







Type of use *.





Yes





Catalog





Selectable entry: "Mast", "Farming", "milk", "Laying hens", "Breeders", "mixed", etc.







Annual total of the quantity





Yes





Number





Annual total of the quantity in your application unit







Application unit





Yes





Catalog





Unit applicable to smallest "ml", "l", "g", "kg", "PK"

















* Maintenance of the list by ÖTK

* in accordance with the published lists of operators site

 

 

 

 

Annex 4

Voluntary part: application data



Field name









Duty









Format









Description









MelderID





Yes





Text





ID of the veterinarian's or LFBIS of operation, if not exist VIS registration number or ID of Bündlers







Filing year





Yes





Number





Calendar year of application







Type of message *.





Yes





Catalog





"Application"







Application by TA





Yes





Boolean





Application by veterinarian yes/no







Date





Yes





Date





Date of the application in the format DD. MM.JJJJ







ID of the veterinarian





No





Text





ID of the applying veterinarian







LFBIS





Yes





Text





Number of (LFBIS) - if not present, is VIS registration number operation, where is the application of medicinal







Registration number *.





Yes





Text





Approval of the medicinal







Species *.





Yes





Catalog





to select species: "Beef", "Pig",... etc.







Type of use *.





Yes





Catalog





 







Animal characteristics





Yes





Text





Beef: ear tag number

Herds of pigs or chickens: -, barn, or bays label







Day total applied amount





Yes





Number





applied amount in the application of







Application unit *.





Yes





Catalog





Unit applicable to smallest "ml", "l", "g", "kg", "PK"







Number of treated animals





Yes





Text





Number of treated animals







Diagnostic code *.





Yes





Catalog





 







Duration (in days)





Yes





Text





Application - specified on the delivery slip or duration of use







Batch number





No





Text





Batch of medicinal







HAPO_ID *.





No





Text





Identification number of the veterinary medicine cabinet





* in accordance with the published lists of operators site

* Maintenance of the list by ÖTK

 

 

Article 2

Ordinance of the Federal Minister for health of the pharmacy operation order in 2005 changes

On the basis of article 62a of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by the Federal Act Federal Law Gazette I no. 162/2013, and §§ 7 para 1 and 2, 24 para of 5, 31 para of 4, 34 para of 2, 38 and 60 par. 3 of the pharmacy Act, RGBl. No. 5/1907, last amended by Federal Law Gazette I no. 80/2013, is prescribed:

The pharmacy operation order 2005 - subscription 2005, Federal Law Gazette II No. 65/2005, as last amended by Federal Law Gazette II No. 474/2010, is amended as follows:

1 § paragraph 1 is inserted after 60 the following paragraph 1a:


"(1a) when opening a veterinary medicine cabinet, the district administrative authority for the home pharmacy has a site number according to the requirements of annex 1 pt. 1.2.1. the regulation on the establishment and maintenance of vet list and the list of home pharmacy leading veterinarians and veterinarians, as well as on the form and the content of the vet card (veterinarian list and ausweisVO), Federal Law Gazette II No. 421/2012, as last amended by Federal Law Gazette II No. 83/2014" ", to forgive and to add the generated site number of the message to the Austrian Veterinary Association about the display in accordance with paragraph 1."

2. para 9-11 is § 60.

3. According to section 60, 60a the following section shall be inserted:

"Record-keeping obligations for veterinary pharmacies of House

§ 60a. (1) the vet the vet has to keep electronic records about the purchase of medicinal products and thereby hold the following information:



1 delivery date, 2. received quantity, 3. name and address of the supplier of 4. name of the medicinal product, as well as 5th in medicinal batch number or 6 at highways preparations the date of manufacture.

(2) the veterinarian / the vet has to lead 60 par. 3 and 4 electronic records, from which the orders pursuant to section



1. the date of manufacture, 2. type and quantity of ingredients, 3. the type of production and 4. the duration of usability (expiration date) cannot be determined.

(3) the veterinarian / the veterinarian has about the dispensing of veterinary medicinal products containing the antibiotic active substances and according to the provisions of the animal medicines Control Act (TAKG), Federal Law Gazette I amended no. 28/2002, by the Federal Act Federal Law Gazette I no. 36 / 2008, - with the exception of § 4 b TAKG here but not given to equidae - were issued to maintain electronic records. The records must set according to the specifications of annex 1.

(4) for pharmaceutical products falling under paragraph 3 and b TAKG which applies - but not for equidae were made according to the provisions of the TAKG - with the exception of section 4, has the vet the vet to keep electronic records that have to contain the following information:



1. date of delivery, 2. recipient of the medicinal product (LFBIS- or VIS registration number), 3. approval number of the medicinal product and 4. amount.

(5) the records referred to in paragraphs 1 to 4 shall be by means of electronic data processing, which must ensure that the data are available during the storage period in the veterinary medicine cabinet.

"(6) veterinary surgeons/veterinarians, who are committed to the keeping of electronic records pursuant to paragraph 3 have an in accordance with the veterinary antibiotics MengenströmeVO, Federal Law Gazette II No. 83/2014, to use a electronic interface, whose establishment and operation the Selfcare leading veterinarian or the pharmacy leading veterinarians to wear has."

4. the section 78 be added following paragraph 7 to 9:

"(7) § 60 para 1a and Appendix 1 in the version of Federal Law Gazette. II No. 83/2014 with April 15, 2014 into force." For veterinary house pharmacies, which are already registered by 14 April 2014 with the Austrian Veterinary Association, the site number is submitted by the Federal Minister of health on the Austrian Veterinary Association.

(8) § 60a in the version of Federal Law Gazette. No. 83/2014 comes II with 15 April 2014 in force, at the end of the 14 April 2014 is § 60 para 9-11 override.

(9) the obligation for the management of electronic records according to section 60a comes with 1 January 2019."

 

 

 

 

5 the following Annex 1 is added to of the regulation:

'Annex 1

Data of the quantities of veterinary house pharmacies



Field name









Format









Description









Date





Date





Date of the submission in the format DD. MM.JJJJ







Hapo_Id *.





Text





Identification number of the veterinary medicine cabinet







LFBIS





Text





Number of (LFBIS) - if not present, is VIS registration number of operation - the operation on which the medicinal application/tax is







Registration number *.





Text





Approval of the medicinal







Species *.





Catalog





To select species: "Beef", "Pig", "Poultry", "Horse", "Fish", "Sheep", "Goat", etc.







Type of use





Catalog





Selectable entry: "Mast", "Farming", "milk", "Hen", "Parent", mixed, etc.







Lot





Number





Amount in the application unit







Application unit





Text





Unit applicable to smallest "ml", "l", "g", "kg", "PK"





* Maintenance of the list by ÖTK

"* in accordance with the published lists of operators site"

Article 3

Ordinance of the Federal Minister for health, modifies the regulation on the establishment and maintenance of vet list, as well as on the form and content of the vet card

On the basis of §§ 5 para 6, 6 para 2, 10 para 1 and 2, 13a and 73 of the veterinary Act, Federal Law Gazette No. 16/1975, as last amended by Federal Law Gazette I no. 80/2013, is prescribed:

The regulation on the establishment and maintenance of vet list, as well as on the form and the content of the vet card, Federal Law Gazette II No. 421/2012, is amended as follows:

1. the title of the regulation reads: