Competent authority comments received on 9 September 2016
ANNEX I:
SLOVENIA’S COMMENTS TO AND CORRECTIONS OF ENGLISH VERSION OF DRAFT
REPORT
Reference number: DG(SANTE)/2016-8883 - MR Draft Fact-Finding Mission in Slovenia from 7 to 11
March 2016 in order to gather information on the prudent use of antimicrobials in animals
1.
Point 2 of 4.1.1., page 2 of draft report. The last sentence should read as follows:
Preliminary information indicates that sales of antimicrobials increased in 2014
owing to, inter alia, to higher levels of mycotoxins with immune-suppressive
effects found in feed materials.
2.
Point 3 of 4.1.1., page 3 of draft report. The sentence should read as follows:
According to AFSVSPP, a detailed breakdown of use of antimicrobials by
species is not available but several integrated farming enterprises account for a
significant proportion of sales.
3.
Point 4 of 4.1.1., page 3 of draft report. The last sentence should read as follows:
According to AFSVSPP, small quantities of medicated feed produced in other
Member States were brought into the country prior to 2015.
4.
Point 5 of 4.1.2., page 3 of draft report. The first sentence should read as follows:
The division for veterinary medicinal products of the Agency for Medicinal
Products and Medical Devices of the Republic of Slovenia (Javna agencija RS
za zdravila in medicinske pripomočke - JAZMP) is inter alia responsible for
marketing authorisations for pharmaceuticals and immunologicals.
5.
Point 7 of 4.1.2., page 3 of draft report. The last sentence should read as follows:
A team of 5 designated experts out of 14 ICM members is currently preparing a
comprehensive update to the strategy to cover the period to 2022 (see point
38).
6.
Point 8 of 4.1.2., page 4 of draft report. The first sentence should read as follows:
The Veterinary Chamber of Slovenia is the national representative body of the
profession and has currently registered (and licensed to practice) 841
veterinarians from 128 veterinary organisations and other organisations linked
to veterinary activities (not including official veterinarians).
The sentence before last sentence should read as follows:
Other professional and academic organisations are also actively involved in
issues concerning the prudent use of antimicrobials in animals including the
Slovenian Buiatric Association (approximately 150 members), the Slovenian
Small Animal Veterinary Association (142 members), the National Veterinary
Institute and the Veterinary Faculty of the University of Ljubljana.
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Competent authority comments received on 9 September 2016
7.
Point 9 of 4.1.2., page 4 of draft report. The first sentence should read as follows:
According to AFSVSPP, 65 veterinary organisations, which together cover all
farmers in the country, have been granted 10 year concessions to carry out
work on behalf of the State.
8.
Point 10 of 4.1.2., page 4 of draft report. The last sentence should read as follows:
In one example, the representative of a veterinary organisation visited reported
that 96 out of 100 invited farmers participated in an event, which included
presentations on prudent use of antibiotics.
9.
Point 12 of 4.2.1., page 4 of draft report. The first sentence should read as follows:
According to JAZMP, five products containing antimicrobials (two of which were
for food producing animals and three for companion animals) were granted a
special authorisation for their introduction / import into Slovenia in 2014 based
on the relevant national legislation.
The second sentence should read and be extended as follows:
According to Slovenian national legislation, veterinarians from other Member
States, who are allowed to work periodically in Slovenia, are permitted to bring
with them small quantities of veterinary medicinal products, excluding
immunological medicinal products, which do not exceed the daily needs of the
animals they are treating. Such an activity shall be registered in advance with
the Competent Authority (MAFF, which shall notify thereof AFSVSPP and
Veterinary Chamber of Slovenia). Such a registration has not taken place to
date.
The third sentence should be deleted / omitted from text:
According to AFSVSPP, this mainly concerns specialist horse veterinarians.
10.
Point 13 of 4.2.1., page 5 of draft report. The first sentence should read as follows:
Only the quantity of antimicrobials required for one treatment of an animal / herd
may be dispensed by veterinarians, or by pharmacies based on veterinary
prescription only, for medicated feed to be delivered to a relevant farm.
11.
Point 15 of 4.2.1., page 5 of draft report. The last sentence should read as follows:
Unused veterinary medicinal products are returned to the veterinary practices.
12.
Point 16 of 4.2.1., page 5 of draft report. The sentence should read as follows:
National Act (ZZdr2, Article 126) preventing the purchase and dispensing via
the internet of veterinary medicinal products, which shall be dispensed based
on veterinary prescription only, was published in 2014.
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Competent authority comments received on 9 September 2016
13.
Point 17 of 4.2.2., page 6 of draft report. The last sentence should read as follows:
The wording of the product information for one product will be updated during
the next marketing authorisation variation.
14.
Point 21 of 4.2.3., page 6 of draft report. The first sentence should read as follows:
Each individual dispensing of veterinary medicinal products must be recorded in
the records of veterinary organisation and in the standard logbook of veterinary
treatments at the holding keeping food producing animals.
15.
Point 23 of 4.2.3., page 6 of draft report. The sentence should read as follows:
A test model for reporting on the consumption of antimicrobials at a pig farm is
being prepared by AFSVSPP.
16.
Point 26 of 4.3.1., page 7 of draft report. The first and the second sentence should
read as follows:
According to AFSVSPP, there is currently no new legal regulation in place,
which would additionally restrict the excessive use of antimicrobials. As regards
CIAs, there are in place the Specific Warnings by drug manufacturers on the
precaution measures at drug use in animals, which are to be followed based on
the existing applicable legislation already.
As from 2008, AFSVSPP has been focussed on raising awareness about the
prudent and responsible use of antimicrobials as set out in the AMR-Combatting
National Strategy (see point 7).
17.
Point 30 of 4.3.1., page 7 of draft report. The sentence should read as follows:
According to AFSVSPP, several recommendations on the use of antimicrobials
in veterinary medicine were prepared as part of the Targeted Research Project
'Antimicrobial Resistance in Bacteria of Animal Origin'7.
18.
Point 32 of 4.3.1., page 8 of draft report. The second sentence should read as follows:
The pig famer visited had noted an improvement in this respect after
strengthening biosecurity measures such as by including disinfection barriers,
restricting access to the animals and thorough cleaning and disinfection
between production cycles.
19.
Point 33 of 4.3.1., page 8 of draft report. The first sentence should read as follows:
On the farm concerned, there was some evidence of visits by the veterinarian
(although the visits were only recorded when there was something to note,
which is compliant with national legislation) and records complying with
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Competent authority comments received on 9 September 2016
applicable national legislation for the use of veterinary medicinal products and
the associated prescriptions were available.
20.
Point 39 of 4.3.1., page 9 of draft report. The second sentences should read as
follows:
Most notably, these include upgrading and supplementing the existing IT and
support systems, inter-linking a number of databases, and implementing an
electronic reporting system for sales and consumption of antimicrobials.
21.
Point 40 of 4.3.2., page 9 of draft report. The two sentences should read as follows:
AFSVSPP is responsible for controls of the use of medicinal products, and of
use-related traceability of veterinary medicinal products, while JAZMP can also
carry out checks on topics within its remit such as good distribution practice at
wholesalers of medicines. There are currently eleven (11) active wholesalers of
veterinary medicinal products and five (5) approved feed mills producing
medicated feed.
22.
Point 41 of 4.3.2., page 9 of draft report. The sentence before last sentence should
read as follows:
These also showed that, in few cases, antimicrobials not prescribed by a
veterinarian and illegally sourced were used.
23.
Point 44 of 4.3.2., page 9 of draft report. The first sentence should read as follows:
According to the Veterinary Chamber of Slovenia, it may perform additional expert
controls if it is suspected that veterinary organisations have seriously violated the rules
on expertise and sanctions can be imposed if appropriate.
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Competent authority comments received on 9 September 2016
ANNEX II:
SLOVENIA’S COMMENTS TO AND CORRECTIONS OF SLOVENIAN TRANSLATION OF
DRAFT REPORT
Reference number: DG(SANTE)/2016-8883 - MR Draft Fact-Finding Mission in Slovenia from 7 to 11
March 2016 in order to gather information on the prudent use of antimicrobials in animals
I.
GENERAL COMMENTS (applicable to the entire text)
1.
“protimikrobna odpornost” shall be corrected to: “odpornost mikrobov proti
protimikrobnim zdravilom”
2.
“protimikrobna sredstva” shall be corrected to: “protimikrobne učinkovine” if not evident
from the context that this means “protimikrobna zdravila”
II.
SPECIFIC COMMENTS (applicable to certain terms)
1.
“flushing” / “izplakovanje” shall be corrected to: “čistilne šarže krme”
2.
“rezultati posredovanih stališč” shall be corrected to: “zaključki napotitvenih postopkov”
3.
“sestrami in zdravstveniki” shall be corrected to: “negovalci”
4.
“barriers” / “pregrad” (point 32) shall be corrected to: “dezinfekcijske bariere /
dezinfekcijskih barier”
5.
“veterinarske ordinacije” shall be corrected to: “veterinarske organizacije”
6.
“po postopkih predložitve” (point 5) shall be corrected to: “po napotitvenem postopku”
(“referral” shall be translated as “napotitveni postopek”)
7.
“Protimikrobna odpornost pri bakterijah živalskega izvora“ (point 30) shall be corrected
to: “Odpornost proti antibiotikom pri bakterijah živalskega izvora”
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