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

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 VMPs but it does not highlight the need to protect animal welfare during the use of animals for testing nor during their…

Organic husbandry plays an important role in german agriculture. Herbal and homeopathic veterinary medicinal products are therefore highly important as they are explicitly recommended as the first line treatment of animal diseases on organic farms (EU Regulation 2018/848 on organic production). Taking this into consideration, the COMMISSION IMPLEMENTING REGULATION (EU) /...

Our organisation, the VMDA, represents the largest group of manufacturers of veterinary medicines and other animal health products in Australia, and we export around the world, including to EU countries. We also import many products from the EU. The VMDA congratulates the EU on its eminently practical proposal for the regulation of animal health products.

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 medicinal products, traditional herbal veterinary medicinal products and homeopathic veterinary medicinal products.

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.

Regulation (EU)2019/6 provides (recital (68)): Good manufacturing practice should take into account EU and international animal welfare standards when active substances are produced from animals. Recital (2) of the Regulation: good manufacturing practice in the Union should continue to be brought into line with the relevant int. standards.

Filed in German · English published by the European Commission

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 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13994-Veterinary-medicines-rules-on-good-manufacturing-practices_en COMMISSION IMPLEMENTING REGULATION (EU) /...

The Animal Welfare Association of Iceland (Dýraverndarsamband Íslands) would like to urge the Commission to follow the European Parliaments and citizens request and set high animal welfare standards for the good manufacturing practices of veterinary medicines. This matter is at the top of the Associations agenda since Iceland remains home to blood farms for Pregnant Mare Serum Gonadotropin (PMSG) production.

Dear Sir/Madam, please find attached the opinion on the GMP guide for veterinary medicinal products. We would like to point out that the consultation deadline of only four weeks is considered insufficient to thoroughly assess all specific requirements and possible changes. In addition, the envisaged transitional period of eight months does not provide an adequate possibility for manufacturers to adapt.

Filed in German · English published by the European Commission

In the past years, several studies (e. g. https://www.aok.de/mk/cms/fileadmin/user_upload/AOK-BW/CSR_Info_Hub/Policy_Paper_Sustainable_supply_of_pharmaceutical_products_AOK.pdf) have shown that fluctuant and peak concentrations of pharmaceuticals in the environment can be attributed to emissions from pharmaceutical production processes, often unintentionally.

As a French and European citizen, I want the European Commission to include ambitious animal welfare standards in the manufacture of veterinary medicines. In particular, I would like to see a ban on the collection of blood from pregnant mares and on the use of hormone derived from the blood of mares in the composition of veterinary medicinal products.

Filed in French · English published by the European Commission

The European Commission must take into account the situation of animal suffering, in particular the constant taking of pregnant mares; permanent and binding sampling that destroys the health of equidae. Permanent sampling must stop, from farms which do not have anything to do with animal experiments, from open-cast laboratories. Animal welfare must be the priority, but opencast blood farms are encountered.

Filed in French · English published by the European Commission

although my profession directly involves me in the use of this type of medicine (eCG), I would like to see the current sampling practices on pregnant mares removed or replaced by a quick alternative. It is necessary to support the use of a molecule for intensive livestock farming, where it is often used systematically, so that ad hoc curative use should be the rule.

Filed in French · English published by the European Commission

The European Commission needs to put in place strong measures to ensure animal welfare, in particular to replace practices detrimental to animal welfare. It is unacceptable for horses to be exploited in the worst way! I am thinking above all of the use of eCG hormone in several veterinary formulations. This hormone is derived from blood samples from pregnant mares.

Filed in French · English published by the European Commission

Hello, in my capacity as a French and European citizen, I would like the European Commission to be uncompromising as regards animal welfare in the manufacture of veterinary medicines. I would like to see, in particular, a ban on blood collection from pregnant mares and on the use of hormone derived from mares in the composition of veterinary medicinal products.

Filed in French · English published by the European Commission

Publication of draft documents for comments within 4 weeks timeframe is not considered sufficient to allow careful review of all specific requirements, specifically when the final text will potentially become stricter than the currently existing GMP-guide and its Annexes and in the format of an Implementing Regulation immediately legally binding after a short transition period.

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 welfare when active substances are prepared from animals.

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 regulation, - Legislators and Inspectors only have to manage & update 1 set of applicable regulation on GMP.

We are supposed to be humans with sensitivity, reason, intelligence, compassion in front of the suffering of other living beings. Yet, when the productivist logic determines the amount of our income, we turn into monstres and we take as many products as possible from such an intelligent animal, the horse.

Filed in French · English published by the European Commission

Hello, the inclusion of animal welfare standards in the manufacture of veterinary medicinal products should not be an option. I see that blood farms continue around the world to supply the EU with ECG hormone. LECG collection practices cause significant and unacceptable animal suffering and abuse.

Filed in French · English published by the European Commission

Hello, these blood farms wherever they are (India, Argentina, etc.) are innumerable cruelty and generate human behaviour that insults the human race. The corollary is intensive chicken to recover umbilical cords. How did we get here? The European Commission, European countries cannot commit themselves in such acts.

Filed in French · English published by the European Commission

The Animal Welfare Association of Zurich (TSB) calls on the European Commission to include high animal welfare standards in Good Manufacturing Practice (GMP), in particular the 3 Rs principle and a ban on blood collection from pregnant animals/horses. Animal welfare standards are not even mentioned in the proposed draft. This is not acceptable. A detailed opinion of the TSB can be found in the annex.

Filed in German · English published by the European Commission

The Animal Welfare Foundation urges the European Commission to include high animal welfare standards in the Good Manufacturing Practice (GMP), in particular the 3 R principle and a prohibition to take blood from pregnant animals/horses. Animal welfare standards are not even mentioned in the draft presented. This is unacceptable. The AWFs statement can be found attached.