Veterinary Drugs
Medicinal products for animals, including pharmaceuticals and biologicals, subject to authorisation, maximum residue limits (MRLs) in food of animal origin, and environmental impact assessments.
Foresight tracks Veterinary Drugs developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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Last updated
13 May 2026, 11:53
Latest Veterinary Drugs alerts
The most recent regulatory and guidance signals tracked by Foresight
Lithuania VMVT Adopts 2026 Dairy Cow Mastitis Antimicrobial Resistance Monitoring Programme
Lithuania’s State Food and Veterinary Service has adopted a 2026 surveillance programme for mastitis pathogens in dairy cows and their susceptibility to antimicrobials, with binding rules on sampling, laboratory testing, farmer responsibilities and EUR 83,000 in dedicated funding, effective from May 2026. This significantly reinforces antimicrobial resistance monitoring and stewardship expectations in the Lithuanian dairy sector, tightening oversight of antibiotic use, data reporting and milk quality management for producers and accredited laboratories.
LithuaniaColombia (ICA) Drafts Resolution on Good Manufacturing and Storage Practices for Veterinary Products (G/SPS/N/COL/421)
Colombia’s agricultural authority has proposed a new GMP and storage certification regime for companies manufacturing or warehousing veterinary medicines and related products, with application planned from October 2026. If adopted, this will raise compliance expectations for veterinary supply chains and importers, aligning national controls with updated Andean veterinary standards and introducing time-bound certification and transition obligations, including a 2031 deadline for biologicals.
ColombiaUS FDA Seeks Stakeholder Participation in AGDUFA Reauthorization Consultation Meetings
FDA has opened stakeholder consultation meetings to inform reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), asking organisations to register representatives by 1 June 2026 to participate in recurring discussions with the Agency and industry. Generic animal drug sponsors and veterinary stakeholder groups should consider engaging early in this process to shape future user fee commitments and review resources before the current AGDUFA IV authority expires in 2028.
United StatesMissouri SB1724 Referred to Judiciary Committee; Would Classify Xylazine as Schedule III Controlled Substance
Missouri’s SB1724 would classify the veterinary sedative xylazine as a Schedule III controlled substance while preserving specified authorised animal-health uses, and it has advanced to the Senate Judiciary and Civil and Criminal Jurisprudence Committee in May 2026. If enacted, manufacturers, distributors, veterinarians, and pharmacies operating in Missouri would face tighter controls and monitoring around xylazine, so they should begin assessing supply chains, prescribing practices, and diversion-prevention measures in anticipation of possible passage.
United StatesUkraine Draft Cabinet Resolution on Fee Methodologies for Evaluation of Veterinary Medicinal Product Registration Dossiers and Changes
Ukraine’s Ministry of Economy has released a draft Cabinet resolution to formalise methodologies for calculating fees charged for evaluating veterinary medicinal product registration dossiers and subsequent registration changes, now open for public input as of early May 2026. If adopted, this will clarify and potentially adjust cost structures for companies seeking to register or vary veterinary medicines in Ukraine, affecting budgeting, pricing and market-access planning for animal-health portfolios.
UkraineUkraine Publishes Draft Decree On Fee Methodologies For Veterinary Medicinal Product Registration
Ukraine’s economic ministry has opened consultation on a draft Cabinet decree that would approve methodologies for calculating the fees charged for scientific evaluation of veterinary medicinal product registration dossiers and subsequent registration changes. These methodologies would formalise how authorities calculate cost-recovery charges, shaping the fee burden for companies registering or updating veterinary medicines in Ukraine and informing future budgeting and pricing decisions.
UkraineEMA Opens Consultation On Revised Annexes To VICH GL18 Residual Solvents Guideline For Veterinary Medicinal Products
In April 2026 EMA opened a public consultation on revised Annex I and new decision trees to the VICH GL18/ICH Q3C residual solvents guideline for veterinary medicinal products. These changes could alter how manufacturers justify and control residual solvent levels in EU veterinary product quality dossiers, so teams should review the draft annexes and prepare feedback before the consultation closes in June 2026.
European UnionEU Expert Group Issues Cascade-Use Recommendations Under Veterinary Medicinal Products Regulation (EU) 2019/6
An EU expert group on veterinary medicinal products has issued non-binding recommendations on when veterinarians may use cascade prescribing under Regulation (EU) 2019/6, clarifying the relationship between Article 106 and Articles 112–114 and outlining illustrative clinical scenarios. This guidance shapes expectations around off-label use, reporting of lack of efficacy and adverse events, and emerging antiparasitic resistance, signalling how EU authorities are likely to interpret veterinary cascade rules in practice for manufacturers and prescribers.
European UnionEMA Publishes 2026 Pharmacovigilance Recommendations for Centrally Authorised Veterinary Medicinal Products
European Medicines Agency has issued its 2026 compilation of pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicines, updating product information and safety monitoring advice for a range of vaccines and treatments across species. Marketing authorisation holders and veterinary teams should review whether their products are listed, prioritise implementation of new warnings and monitoring requirements such as strengthened diabetic ketoacidosis risk management for certain cat medicines, and align pharmacovigilance systems and client communications accordingly.
European UnionTaiwan TFDA Updates Method for Testing Aminoglycoside Antibiotic Residues in Honey and Milk (II)
Taiwan’s TFDA has updated its official LC-MS/MS method for testing residues of seven aminoglycoside antibiotics in honey and milk, with the revised procedure taking effect immediately on 29 April 2026. This change fine-tunes analytical conditions and documentation without altering residue limits, meaning enforcement labs will keep targeting the same substances and LOQ levels while laboratories and producers must align their testing protocols with the new method.
TaiwanTaiwan TFDA Amends Aminoglycoside Antibiotic Residue Test Method for Animal-Derived Foods
Taiwan’s Food and Drug Administration has updated its LC-MS/MS method for monitoring residues of seven aminoglycoside antibiotics in meat, offal and eggs, with the revised method taking effect immediately from late April 2026. The change refines analytical parameters, naming and documentation without altering analytes or quantitation limits, signalling tighter and more consistent enforcement of veterinary drug residue controls in animal-derived foods.
TaiwanEMA Issues Guidance On Article 62 Variations For EU Veterinary Medicinal Products
EMA has issued revised guidance explaining how to classify variations requiring assessment under Article 62 of Regulation (EU) 2019/6 for EU veterinary medicinal products and what documentation marketing-authorisation holders must submit with those applications. This codified framework and annexed checklists give veterinary companies clearer expectations on which changes trigger a full assessment, likely review timelines, and how to structure dossiers, reducing the risk of invalid or delayed variation procedures.
European UnionItalian Ministry of Health Warns About Unauthorized Online Antiparasitic Products for Pets
In April 2026, Italy’s Ministry of Health warned that unlicensed “natural” antiparasitic products for pets are being sold online without scientific evidence or valid veterinary authorisation, creating health risks for animals and owners. The advisory signals closer monitoring and enforcement with the Carabinieri NAS and underscores the need for manufacturers, distributors, and platforms to ensure that only authorised veterinary medicines are marketed in Italy.
ItalySpain AEMPS Adopts Technical Requirements for Simplified Registration of Certain Non‑Prescription Veterinary Medicines
SpainEuropean Commission Grants EU Marketing Authorisation for AviGate S. Infantis Salmonella Vaccine for Chickens
The European Commission has granted an EU-wide marketing authorisation under Regulation (EU) 2019/6 for AviGate S. Infantis, a live Salmonella Infantis vaccine for chickens, following a positive EMA opinion in March 2026. This adds a new centrally authorised veterinary vaccine to the Union market, giving poultry producers and veterinarians another option for Salmonella control while triggering standard obligations under the veterinary medicines framework.
European UnionViet Nam Draft Circular on Medium- and High-Risk Agricultural Products (G/TBT/N/VNM/401)
In April 2026 Viet Nam notified the WTO of a draft Circular updating the list of medium- and high-risk agricultural inputs under the Ministry of Agriculture and Rural Development, replacing Circular 16/2021/TT-BNNPTNT and open for public comment until 17 June 2026. This could tighten conformity-assessment obligations for suppliers of seeds, fertilisers, feed, veterinary medicines, aquaculture treatment products and related goods entering the Vietnamese market, so companies should check whether their products fall within the revised risk list and consider submitting comments.
VietnamEMA Consults on Concept Paper for Guidance on Biosimilarity of Veterinary Biologicals
EMA has launched a public consultation on a concept paper to develop detailed guidance for demonstrating biosimilarity of biological veterinary medicinal products under Regulation (EU) 2019/6, with comments due by 31 July 2026. This will clarify data expectations for manufacturers of veterinary biosimilars, shaping future comparability packages, development strategies, and EU market authorisation planning over the coming years.
European UnionEuropean Commission Amends Lidocaine Maximum Residue Limits Under Regulation (EU) No 37/2010
In April 2026 the European Commission prepared an implementing regulation to amend Regulation (EU) No 37/2010 by reclassifying lidocaine’s maximum residue limit in foodstuffs of animal origin. This change will alter residue-compliance conditions for lidocaine-containing veterinary medicines and animal-derived foods, so EU manufacturers and food operators must review updated MRL tables and withdrawal periods once the Official Journal text is available.
European UnionEMA Consults on Revision 2 of Guideline on Declaration of Herbal Substances and Preparations in Herbal Medicinal Products
In April 2026 the European Medicines Agency opened a public consultation on Revision 2 of its guideline on how herbal substances and preparations must be declared in SmPCs, package leaflets and labelling for herbal and traditional herbal medicinal products, with comments due by 30 June 2026. The update tightens expectations for marketing authorisation holders and extract suppliers to provide consistent DERgenuine and herbal-mass declarations, explicit extraction solvent details and clearer naming of herbal components, which is likely to drive dossier and labelling adjustments across EU herbal product portfolios.
European UnionVietnam Draft Circular Amends Veterinary Medicines Registration and Import Licensing Rules
Vietnam’s Ministry of Agriculture and Environment has issued a draft circular amending veterinary medicines registration, renewal, import licensing and trial authorisation procedures, with stakeholders invited to comment by 20 June 2026. If adopted in 2026, the changes will affect required GMP/ISO documentation and significantly shorten several review timelines, so veterinary drug manufacturers and importers should adjust their Vietnam registration strategies and supply chain lead times.
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