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Uniform rules on good manufacturing practice for veterinary medicinal products and active substances

Food safety, Public health

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

Links

Public consultation

ID: 13994

Lobbying Activity

13 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 a few comments on the draft IA on GMPs of Veterinary Medicinal Products 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 Tierarzneimittel. 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

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 17 Feb 2025

Please refer to attached PDF file.

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

European Industrial Gases Association AISBL, 17 Feb 2025

EIGA believe that there is no need to include in the proposed Annex to the regulation a full copy of the GMP Annex 6, but instead it is more effective to only refer in this Annex to the regulation, to the existing regulation on GMP Annex 6 Medicinal Gases. Indeed, by referring to an existing…

Consultation response

World Horse Welfare, 19 Feb 2025

World Horse Welfare welcomes the Commission Implementing Regulation (CIR) on good manufacturing practice for veterinary medical products (VMP) noting that these are essential for both equine health and welfare. The proposal contains reference to animal health, mainly in relation to the quality of…

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 WELFAM / 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

, 18 Feb 2025

Thank you for the opportunity to provide feedback on this draft Implementing Regulation. Please find attached our general remarks and a specific comment for your consideration.

Consultation response

ECA Foundation, 18 Feb 2025

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