Notification Detail | TRIS - European Commission

Proposal of the Swedish Medical Products Agency (HSLF-FS 2021:xx) on labelling and package leaflets for veterinary medicinal products

Notification Number:

2021/0398/S (Sweden)

Date received:

29/06/2021

End of Standstill:

30/09/2021 (closed)

Draft Text:

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

Impact assessment:

SV DE EN FR

Final Text:

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

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Message

Message 002

Communication from the Commission - TRIS/(2021) 02412
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2021/0398/S

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: 202102412.EN)
1. MSG 002 IND 2021 0398 S EN 29-06-2021 S NOTIF

2. S

3A. Kommerskollegium
Box 6803, 113 86 Stockholm Sverige
Tel: 08-690 48 00, Fax: 08-30 67 59
epost: 9834@kommers.se

3B. Läkemedelsverket

4. 2021/0398/S - C00P

5. Proposal of the Swedish Medical Products Agency (HSLF-FS 2021:xx) on labelling and package leaflets for veterinary medicinal products

6. Veterinary medicinal products

7. - The Regulation concerns an area of EU law; Regulation of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.

8. Requirements that packaging containing veterinary medicinal products shall be labelled with a national identification code and that the package leaflets of these medicinal products shall be in a certain format and contain certain information in addition to the requirements of Regulation (EU) 2019/6.

9. Ensure that veterinary medicinal products on the Swedish market are safe and correctly labelled and that the package leaflet provides the necessary information.

10. No basic texts available

11. No

12. -

13. No

14. No

15. Yes

16. TBT aspect

No - The project has no significant impact on international trade.

SPS aspect

No - The draft is neither a sanitary nor phytosanitary measure

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

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

Disclosed messages

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