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Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products

Food safety, Public health

This initiative will establish common rules for the manufacturing of active substances used as starting materials in veterinary medicinal products.

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Public consultation

ID: 14388

Lobbying Activity

10 responses

Consultation response

Eurogroup for Animals, 17 Feb 2025

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products in its Recital (68) exposes that: The good manufacturing practice for the purpose of this Regulation should take into account the Union and international standards of animal…

Consultation response

International Federation of Organic Agriculture Movements EU Regional Group, 19 Feb 2025

The Regulation laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council and all connected Annexes should consider in particular the special conditions in the production of herbal veterinary…

Consultation response

AnimalhealthEurope, 19 Feb 2025

AnimalhealthEurope is happy to provide the European Commission with a few comments on the draft Implementing act on Good Manufacturing Practice for active substances used as starting materials in veterinary medicinal products. These comments can be found in the attached document.

Consultation response

Bundesverband der Pharmazeutischen Industrie e.V., 19 Feb 2025

Sehr geehrte Damen und Herren, anbei finden Sie im Anhang die Stellungnahme zum GMP-Leitfaden für Wirkstoffe (API). Wir möchten gern anmerken, dass die Konsultationsfrist von lediglich vier Wochen als unzureichend erachtet wird, um alle spezifischen Anforderungen und möglichen Änderungen gründlich…

Consultation response

Deutscher Tierschutzbund - German Animal Welfare Federation, 19 Feb 2025

Verordnung(EU)2019/6 sieht vor (Erwägungsgrund(68)): Die gute Herstellungspraxis sollte EU- und internationale Tierschutzstandards berücksichtigen, wenn Wirkstoffe aus Tieren hergestellt werden. Erwägungsgrund(2) der VO: die in der Union geltende gute Herstellungspraxis soll weiterhin mit den…

Consultation response

Research Institute of Organic Agriculture in Europe, 19 Feb 2025

Based on the both following points, (a) In EU-Regulation 2019/6, it is stated that There is insufficient information to date on traditional herbal products used to treat animals in order to allow the establishment of a simplified system. Therefore, the possibility of introducing such a system…

Consultation response

WELFARM, 19 Feb 2025

Vous trouverez ci-joint l'avis de l'association WELFARM / Protection Mondiale des Animaux de Ferme. WELFARM est une organisation non gouvernementale française agissant pour le bien-être des animaux d'élevage

Consultation response

Vereinigung der am Drogen- und Chemikalien-Groß- und Außenhandel beteiligten Firmen e.V., 19 Feb 2025

VDC statement on COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council…

Consultation response

ECA Foundation, 18 Feb 2025

Please find attached the comments of the ECA Foundation / European QP Association

Consultation response

CPA Italian Chemical Pharmaceutical Association, 18 Feb 2025

COMMISSION IMPLEMENTING REGULATION laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council A. It is recommended to include the following…