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Draft Decree amending the Royal Decree of 21 July 2016 on conditions for the use of medicines by veterinarians and by persons responsible for animals

Notification Number:

2019/0388/B (Belgium)

Date received:

31/07/2019

End of Standstill:

04/11/2019

Draft Text:

NL SK LV HR SL IT EL FI LT BG DA HU SV CS PL ET MT PT RO DE EN ES FR

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Message

Message 002

Communication from the Commission - TRIS/(2019) 02134
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2019/0388/B

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201902134.EN)
1. MSG 002 IND 2019 0388 B EN 31-07-2019 B NOTIF

2. B

3A. FOD Economie, KMO, Middenstand en Energie
Algemene Directie Economische Analyses en Internationale Economie
City Atrium
Vooruitgangstraat 50
B - 1210 Brussel
Tel: 02/277.74.81

3B. Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
Afdeling Wetgeving en Geschillen
Victor Hortaplein 40/40
B - 1060 Brussel
Tel: 02/528.40.00

4. 2019/0388/B - C10P

5. Draft Decree amending the Royal Decree of 21 July 2016 on conditions for the use of medicines by veterinarians and by persons responsible for animals

6. The measures aim to reduce the use of critical antibiotics important for public health in food-producing animals. To this end, rules are imposed for the prescription, provision and administration of such medicines for veterinary use.

7. -

8. The draft Royal Decree contains specific rules for the prescription, provision and administration of critically important antibiotics, as listed in the Annex to the Decree, by veterinarians for metaphylactic and curative treatment in food-producing animals:

- condition of carrying out a preliminary laboratory test from which it can be concluded that the identified bacterial strain is not sensitive to the tested non-critically important antibiotics or to other tested antibacterial substances and is exclusively sensitive to the tested critically important antibiotics;
- conditions for prescribing critically important antibiotics in cases where a preliminary laboratory test is not possible for technical reasons;
- conditions for prescribing critically important antibiotics in exceptional cases of extreme urgency while awaiting the outcome of a laboratory test.

9. The rules contained in this draft Decree aim to assign responsibility to veterinarians for the administration, provision and prescription of critically important antibiotics and thereby impose limits on the use of specific classes of molecules in animals. These rules are in line with the broader objective of limiting the veterinary use of antibiotics which are important for humans (resistance issues).

10. No basic text(s) available

11. No

12. -

13. No

14. No

15. -

16. TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft has no significant impact on international trade.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

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