Notification Detail | TRIS - European Commission

Act amending the Animal Health Act, the Veterinary Medicinal Products Act and the Animal Health Fines Act

Notification Number:

2025/0438/DE (Germany)

Date received:

12/08/2025

End of Standstill:

13/11/2025

Issue of comments by:

European Commission

Draft Text:

DE EN

Click here for a printable version of this page

Message

Message 001

Communication from the Commission - TRIS/(2025) 2151

Directive (EU) 2015/1535

Notification: 2025/0438/DE

Notification of a draft text from a Member State

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20252151.EN

1. MSG 001 IND 2025 0438 DE EN 12-08-2025 DE NOTIF

2. Germany

3A. Bundesministerium für Wirtschaft und Energie, Referat EB3

3B. Bundesministerium für Landwirtschaft, Ernährung und Heimat, Referat 322; 322@bmleh.bund.de

4. 2025/0438/DE - C00A - AGRICULTURE, FISHING AND FOODSTUFFS

5. Act amending the Animal Health Act, the Veterinary Medicinal Products Act and the Animal Health Fines Act

6. — In-vitro diagnostics for testing for the presence of an epizootic disease,
— Authorisation, use and manufacture of immunological veterinary medicinal products,
— Prohibition of movement of infected animals, their products and contaminated objects/substances

7.

8. Article 1 of the Act amending the Animal Health Act, the Veterinary Medicinal Products Act and the Animal Health Fines Act (Amendment to the Animal Health Act) contains regulations on the authorisation, use, manufacture and placing on the market of in vitro diagnostics for testing the presence of a contagious disease in animals (Section 11 (Article 1 No. 14) and Section 12 (Article 1 No. 15)) and on the use of certain unauthorised immunological veterinary medicinal products (Section 11 (Article 1 No. 14)). Provision is also made for prohibitions on the movement of animals which have been infected with a contagious disease or which have been proven to be infected with a disease agent or which may be infected with a disease agent, as well as products from such animals which may be contaminated with a disease agent; the prohibition also applies to objects or substances which may be contaminated with a disease agent (§ 13 (Article 1(17))).
In Article 2 (Amendment of the Veterinary Medicinal Products Act) provisions on the authorisation, use and manufacture of immunological veterinary medicinal products previously contained in the Animal Health Act are transferred to the Veterinary Medicinal Products Act (Sections 35a to 35h (Article 2(5))). Necessary consequential amendments (Infection Protection Act, Animal Vaccine Ordinance) are regulated in Article 3, amendments to the Animal Health Fines Act in Article 4, information on the limitation of fundamental rights in Article 5, the publication authorisation in Article 6 and the entry into force in Article 7. The provisions in Articles 3 to 7 are not relevant to the present notification procedure.

9. The directly applicable EU Animal Health Law – Regulation (EU) 2016/429 and its supplementing Delegated and Implementing Regulations – partly applicable since April 2021 – largely supersedes the national Animal Health Law. In addition, Regulation (EU) 2019/6 on veterinary medicinal products, which has become directly applicable since 28 January 2022, supersedes various provisions of the national animal health law as regards prescriptions on immunological veterinary medicinal products. There is therefore an urgent need to adapt to national law.

10. Reference to the basic texts: Basic texts have been forwarded under a previous notification:
2024/0408/DE
2022/0551/D
2021/0136/D

11. No

12.

13. No

14. No

15. No

16.
TBT aspects: No

SPS aspects: No

**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	Year	Number	Country	Type	Title	Date received	Is answer to
112696	2025	2152	COMEuropean Commission	003	Receipt of the draft text	12-08-2025
112697	2025	2153	COMEuropean Commission	037	Competitiveness analysis	12-08-2025
113734	2025	3190	COMEuropean Commission	303	Comments	11-11-2025
114235	2025	3690	DEGermany	201	Answer of the notifying Member State	18-12-2025	2025-3190

Languages

Stakeholders Contributions

The TRIS website makes it easy for you or your organization to share your views on any given notification.

Due the notification’s status or the end of standstill, we are currently not accepting any further contributions for this notification via the website.

No contributions were found for this notification