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

Read the untranslated law here: https://www.global-regulation.com/law/austria/2995916/nderung-der-veterinr-antibiotika-mengenstrmevo%252c-der-apothekenbetriebsordnung-2005--sowie-der-tierrzteliste--und-ausweisvo.html

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5. Regulation of the Federal Minister for health, modifies the veterinary antibiotic MengenströmeVO, the pharmacy operating regulations 2005 and the veterinarian list and ausweisVO

Article 1

Regulation of the Federal Minister for health, modifies the 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:

The veterinary antibiotics MengenströmeVO, Federal Law Gazette II No. 83/2014, is amended as follows:

1. in article 5, paragraph 2, the word is "culpably" inserted after the phrase "Paragraph 1".

2. paragraph 6 ABS. 1:

"(1) the creation of sales volumes is as census manufacturers operating in Austria, making marketing authorisation holders (Depositeuren) and drug wholesalers and includes the amounts distributed shall:"



"1. veterinary house pharmacies, 2. public pharmacies, 3. institution pharmacy of the University of veterinary medicine Vienna, 4. apotheke(n) of the Austrian Federal Army, 5. other eligible sites for which the Federal Ministry of health assigns an ID number."

3. in article 7, paragraph 1, the phrase replaced "Paragraph 4" by the phrase "Paragraph 3".

4. paragraph 7 subsection 2:

"(2) which apply 2005, committed individuals who hold antibiotics in its veterinary medicine cabinet, according to section 60a of the subscription or give to the application, have data on the distribution of antibiotics to the application



1 cattle, sheep, pigs and goats as well as 2 other ruminants, hooves, birds, poultry, to make rabbit and the aquaculture animals, provided that they are intended for products on or in the people serving the extraction of food or other application, the implementing authority."

5. in section 9, paragraph 2, the word order is after the word "Data set descriptions" "pursuant to the provisions of the data protection Act 2000, Federal Law Gazette I no. 165/1999, as amended by Federal Law Gazette I no. 83/2013," inserted.

6 paragraph 9 para 3:

"Bundler able must be (3) in addition to accept all output messages of a veterinarian or a vet's same species regarding, edit and forward as annual message, thus at the same time to act as a recognized Registrar in the meaning of § 7 of the concerned species. If these data transfers to those pursuant to section 7 para 2 (mandatory reports of veterinarians and animal doctors), Bundler in the position must be, to reduce the records when the receipt of the data referred to in annex 3 to delete beyond information to generate the annual message from the communications received during the entry period pursuant to § 7 para 2 and to send them the implementing authority."

7. According to article 9, paragraph 3, the following paragraph 3a is inserted:

"(3a) for the use of a Bündlers for the transmission of mandatory messages according to § 7 obligation of § 7 of the vet or veterinarian for the affected species is satisfied."

8. According to § 10 paragraph 3 the following paragraph 4 is added:

"(4) § 5 para 2, article 6, paragraph 1, article 7, paragraph 1 and 2, section 9, paragraph 2, 3 and 3a and annex 2 as amended by Federal Law Gazette II No. 5/2016 with 1 January 2016 into force."

9. Annex 2 is as follows:

"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 House pharmacy the medicinal was traded to the or that ID number awarded points by the BMG the medicinal was traded for community pharmacies and other rightful claimants 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 (such as 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"

Article 2

Regulation of the Minister of health, the pharmacy operation order 2005 modifies the

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. 32/2014, 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. 83/2014, is amended as follows:

1. the introductory phrase of section 60a paragraph 1 reads:

"The vet the vet has to keep preparations electronic records to lead and with the following information about the purchase of medicines and highways:"

2. § 60a para 3 first sentence reads:

"The vet the vet has about the dispensing of veterinary medicinal products that contain antibiotic ingredients and according to the provisions of the animal medicines Control Act (TAKG), Federal Law Gazette I no. 28/2002, as amended by Federal Law Gazette I no. 36 / 2008, - with the exception of § 4 b TAKG - were issued to keep electronic records."

3. the introductory phrase of section 60a paragraph 4 reads:

"For medicinal products which fall under paragraph 3 and in accordance with the TAKG - with the exception of section 4 b TAKG - were fired, as well as for magistral preparations has electronic records to conduct the animal doctor / the veterinarian who have to contain the following information:"

4. section 60a paragraph 4 No. 2 is:

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

5. According to § 79 paragraph 9 the following paragraph 10 is added:

"(10) section 60a paragraph 1, 3 and 4 as amended by Federal Law Gazette II No. 5/2016 with 1 January 2016 into force."

Article 3

Regulation of the Minister of health with the vet list - ausweisVO change the

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

The veterinarian list and ausweisVO, Federal Law Gazette II No. 421/2012, as last amended by Federal Law Gazette II No. 83/2014, is amended as follows:

1 § 6a para 1 last sentence reads:

"The records are to apply to the data set description of the annex 1 pt. 1.1. and to store five years after logging off of the medicine cabinet."

2 the following sentence is added to in section 6a, paragraph 3:

"This list last sentence has also all in paragraph 1 listed records already before entry into force of this regulation in the version of Federal Law Gazette. II Nr. 5 / 2016 registered veterinary pharmacies of House to include only within at the latest one year after its cancellation."

3. paragraph 7 subsection 2:

"(2) any veterinarian badge has an ID number, which is identical with the veterinarian number and contain at least the following information:"



"1 / the first name and surname, 2. the / degree/degrees, 3 date of birth and place of birth, 4th national, 5. the occupation veterinarian" / "vet - a specialist veterinarian title (§ 1 Z 13) may be worn in addition, 6 the date, 7 signature, 8 photograph."

4. after article 7, the following paragraph 7a is inserted:

"Article 7a. (1) they are allowed the Chamber to be be the veterinarian issued in deviation from § 7 para 1 as map on plastic base. The external characteristics of the base material of such veterinarian ID have to comply with the ISO 7810 standard.

(2) the veterinarian statements contain at least the following information pursuant to paragraph 1 to:



1 print "Austrian Veterinary Association", "Austrian Chamber of veterinary surgeons', 'Vet card', 2. the ID number, which is identical with the veterinarian number, 3. the / the first name and surname, 4. the / degree/degrees, 5 date of birth and place of birth, 6 7 nationality occupation veterinarian" / "vet - a specialist veterinarian title (§ 1 Z 13) may be worn in addition, 8.

the date of issue, 9 the signature, 10 the photograph.

(3) the detailed design of the card has to make the Chamber in the borne area of effect in the way of a resolution of the Congress of delegates. A pattern is to publish on the website of the Veterinary Association - after obtaining the consent of the Federal Minister / the Federal Minister of health.

(4) the veterinarian certificates issued pursuant to paragraph 1 the provisions of § 7 para 4 to 7 are to apply by analogy."

5. the following paragraph 6 is added after paragraph 5 section 8:

"(6) Article 6a, paragraph 1 and 3, article 7, par. 2 and § 7a as amended by Federal Law Gazette II No. 5/2016 with 1 January 2016 into force."

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