Veterinary Regulatory Affairs – EU & UK Veterinary Medicinal Products

End-to-end management of veterinary medicinal product registrations and lifecycle compliance across Europe and the United Kingdom. We handle regulatory strategy, dossier preparation, electronic submissions, authority liaison, approvals, and post-approval oversight ensuring every product meets the required standards: safety for the animal itself, the consumer of food derived from treated animals, those handling the product, and the environment; consistent high quality; and efficacy conforming with the claims made on the product’s information leaflet and label.

This service is suitable for:

• Animal Health Companies (SMEs & MAHs): Small-to-mid-sized veterinary pharmaceutical or biotechnology companies, including vaccine developers, lacking an in-house regulatory affairs department or needing additional support during peak workloads.
• Non-EU Manufacturers Seeking EU/UK Entry: Veterinary product manufacturers based outside Europe who require EU/EEA and/or UK marketing authorisations. Under EU law, no veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted, and non-EU applicants typically need a locally established entity to act as the Marketing Authorisation Holder.
• Food-Producing & Companion Animal Product Sponsors: Organisations developing food-producing animal medicines (e.g. livestock antibiotics, anti-parasitics, mastitis treatments) or companion animal products (e.g. pet vaccines, anti-parasitics) that must comply with distinct regulatory considerations – including the requirement to establish Maximum Residue Limits (MRLs) for substances used in food-producing species.
• Established MAHs with Limited Bandwidth: Existing Marketing Authorisation Holders who have internal regulatory teams but choose to outsource specific projects such as managing a complex Decentralised Procedure across multiple countries or preparing for an upcoming veterinary pharmacovigilance inspection – to ensure no compliance gaps during critical periods.

This service may not be the right fit if:

• You require regulatory support outside the EU or UK (our veterinary RA services focus on European and UK frameworks).

You are looking for veterinary clinical trial management or laboratory services while we provide regulatory guidance on study design and data requirements, the physical conduct of trials or laboratory analyses is outside our scope.

• Choosing the Right Authorisation Route: Determining the optimal path to approval Centralised (EMA/CVMP) vs Decentralised (DCP) vs Mutual Recognition (MRP) vs National vs Limited Market Authorisation  in a framework governed by Regulation (EU) 2019/6. The centralised procedure is mandatory for all veterinary medicinal products listed under Article 42(2) of that Regulation; for other products, a centralised application can be made if no other marketing authorisation has yet been granted within the Union. We guide you through this decision based on product type, target species, and intended market reach.
• Meeting Updated Data Requirements: Adapting to the modernised dossier demands under the 2019 legislation including enhanced pharmacovigilance standards, detailed benefit-risk assessments, and specific measures to fight antimicrobial resistance ensuring prudent and responsible use of antimicrobials in animals. We identify gaps early, such as missing environmental risk data or incomplete Maximum Residue Limit (MRL) studies for food animals, to avoid last-minute agency objections.
• EU vs UK Submissions Post-Brexit: Managing separate submission processes now that EU and UK frameworks have diverged. For example, you can submit parallel applications for a new GB MA and a new DCP MA where NI is CMS to facilitate UK-wide coverage and allow for efficient application management. However, parallel submissions are not possible for EU centralised procedures (CAP/EUCE), EU Mutual Recognition procedures (MRP), or Subsequent Recognition procedures (SRP) due to the different timescales and procedures used on a national basis and in the EU. We ensure nothing falls through the cracks when running concurrent EU and UK applications.
• Maintaining Compliance Through Product Changes: Handling post-authorisation obligations such as variations and periodic safety updates. Under Regulation (EU) 2019/6, variations are now classified as Variations Not Requiring Assessment (VNRA) or Variations Requiring Assessment (VRA), replacing the former Type IA/IB/II system. We provide end-to-end management of these changes so you remain in continuous compliance.
• Resource Gaps & Urgent Projects: Filling critical expertise gaps when your team is stretched or facing an inspection. Whether it is rapidly assembling a response to CVMP questions within tight clock-stop deadlines or preparing inspection-ready documentation for an upcoming Veterinary Medicines Directorate (VMD) audit, we step in as an extension of your team.

Regulatory authorities in the EU and UK have well-defined expectations to ensure veterinary products are safe and effective. This section outlines the core requirements you must meet:

• Valid Marketing Authorisation Before Marketing: No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted by the competent authorities of that Member State or in accordance with the centralised procedure. In the EU, the current governing legislation is the Veterinary Medicinal Products Regulation (EU) 2019/6, which replaced Directive 2001/82/EC and became applicable on 28 January 2022. In the UK, the Veterinary Medicines Regulations 2013 (SI 2033), which came into force on 1 October 2013, form the basis of UK veterinary medicines law, now administered independently by the VMD. We ensure your application meets the format and content requirements set out in these laws.
• Safety for All Stakeholders: Regulators require evidence that the product is safe for the target animal, the consumer of food derived from treated animals, those handling the product, and the environment. This means comprehensive studies addressing target animal tolerance, human food safety (via residue depletion studies), user safety, and environmental impact. For food-producing species, active substances must have an established Maximum Residue Limit (MRL)  the highest concentration allowed for a residue in a food product obtained from an animal that has received a veterinary medicine  as set out under Regulation (EC) No 470/2009. The EMA’s Committee for Veterinary Medicinal Products (CVMP) is responsible for recommending MRLs, which become legally binding food safety standards when adopted by the European Commission. Applications to the VMD should provide the information set out in Annex II to EU Regulation 2019/6 and the Veterinary Medicines Regulations Annex 2 Requirements Guidance.
• Demonstration of Quality and Efficacy: Every batch of the product must be consistently manufactured to high quality standards (GMP). The dossier must demonstrate that the product is of consistent high quality, does not deteriorate, and has the stability to last at least until the expiry date, and that the product’s efficacy conforms with the claims made on its information leaflet and label. The efficacy section, including laboratory and field trial data, must substantiate each claim in the Summary of Product Characteristics.
• Pharmacovigilance & MAH Oversight: Having a veterinary pharmacovigilance system and a qualified person responsible for pharmacovigilance (QPPV) is a legal obligation for veterinary medicinal product marketing authorisation holders. Inspectors check that the MAH is fulfilling vigilance duties collecting adverse event reports, submitting safety data, and acting on emerging safety issues. If deficiencies are found during an inspection, they are documented in the inspection report and the MAH must respond with a corrective and preventive action (CAPA) plan. If major gaps are found, a re-inspection will be performed. The frequency of inspection for each MAH is risk-based  it could be based on the quality of the reports submitted or the quality of the signal management process. Section 5 of Regulation (EU) 2019/6 (Articles 73 to 81, Articles 123 and 126) describes the rules for monitoring veterinary medicines, with further detail in Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices.
• Continual Regulatory Maintenance: Granting the licence is not the end  regulators expect the authorisation to be maintained. The MAH shall be responsible for the marketing of the medicinal product, and the designation of a representative does not relieve the marketing authorisation holder of this legal responsibility. All post-approval changes must be submitted as formal variations before implementation (or immediately after, for certain minor “Do and Tell” changes). Under the current EU legislation, the marketing authorisation is initially granted with a five-year validity period. After this period, the MAH can confirm to the Agency that they wish the marketing authorisation to become unlimited in duration; no assessment is involved in this administrative step, and no fee is payable for the amendment. If the MAH replies in the negative or does not respond, the marketing authorisation will automatically expire after the five-year period.

Our approach follows a structured, step-by-step process mirroring the lifecycle of a veterinary product from development through to market and beyond.

Regulatory Strategy Planning

We design a bespoke regulatory roadmap for your veterinary product. This includes selecting the optimal registration procedure  centralised (if mandatory under Article 42(2) of Regulation (EU) 2019/6 or if the product qualifies optionally), Decentralised, Mutual Recognition, national, or Limited Market Authorisation for niche species or rare diseases (where certain data gaps may be acceptable with proper justification). We advise on classification questions (medicinal product vs feed additive vs biocide) and identify requirements early such as whether an MRL assessment, residue depletion studies, or a withdrawal period establishment is needed for food-producing species. Strategy is aligned with your development milestones so all necessary studies are planned and completed in time for submission.

Dossier Preparation & Gap Analysis

We undertake full regulatory due diligence on your draft dossier to make it inspection-ready. Our team reviews each section (quality, safety, efficacy) against EU and UK standards, pinpointing gaps or red flags. For example, we might identify that batch analysis data for all proposed production sites are not included, or that available data on the active substance and excipients need to be evaluated scientifically to predict potential skin and eye irritation and skin sensitisation and propose appropriate user warnings. For Limited Market Authorisations, some data may be omitted from the application package provided they are not critical to the safety of the product and it is possible to mitigate any risks to an acceptable level. Before submission, we ensure your dossier is complete and coherent including expert reports and an overall risk: benefit assessment  minimising the risk of authority objections.

VNeeS / eCTD Publishing & Submission

We compile and publish your application in the required electronic format. In Europe, applications and responses must be submitted electronically and the presentation and format of the dossier must be in accordance with VNeeS (Veterinary Non-eCTD electronic Submission) guidelines  mandatory since 28 January 2022 under Article 6(3) of Regulation (EU) 2019/6. The HPRA, for example, accepts submissions in VNeeS format without paper copies, or through the Common European Submission Platform (CESP) available on the HMA website. All submission typesincluding new applications for centralised, decentralised, mutual recognition and national procedures, variations, renewals, line extensions, and responses to assessment questions  are accepted in VNeeS format. Applicants must prove technical validity before submission and include the validation report in the add-info folder of the VNeeS submission. For UK applications, we prepare the dossier in the format required by the VMD, ensuring content meets UK-specific requirements. In practice, this step includes assembling all application forms, expert reports, module documents, and annexes (including draft SPCs and product literature), then submitting the dossier to the authority on your behalf.

Regulatory Liaison & Query Management

Once submitted, we act as your interface with regulators throughout the evaluation. This involves monitoring procedure timelines and promptly addressing questions or deficiencies raised by assessors. For centralised and decentralised procedures, authorities typically issue a List of Questions or Observations after their initial review phases. Our regulatory scientists coordinate with your technical experts to draft clear, compliant responses  whether explaining a manufacturing process detail, providing additional trial data, or revising product literature. For UK national procedures, we similarly manage VMD queries. Throughout, we maintain a constructive dialogue with the agency and keep you fully informed of progress, translating regulatory requirements into actionable instructions for your team.

Approval & Post-Approval Support

We guide the application through to a successful outcome: the granting of your Marketing Authorisation. At that stage, we review the draft approval documentation (such as CVMP opinion, Commission Decision, or VMD grant letter) to ensure all details  including the Summary of Product Characteristics (SPC), product literature, and any post-approval commitments  are correct. After approval, we help establish your post-authorisation procedures, including setting up or validating a pharmacovigilance system with a veterinary QPPV, scheduling initial PSUR submissions, and ensuring packaging meets all conditions before the product launches (including any required mock-up submissions for artwork assessment). The goal is a seamless transition from approval to market with every compliance requirement addressed.

Ongoing Regulatory Management (Optional)

After the initial launch, clients often retain us to provide a continuous outsourced regulatory function. This can include managing variations over the product’s lifecycle (e.g. adding a new species, changing a manufacturing site, extending shelf life), planning and executing the administrative step to convert a five-year time-limited authorisation into one of unlimited duration, and keeping documentation current as guidelines evolve. We also maintain your regulatory intelligence, alerting you to any upcoming changes in legislation or pharmacovigilance requirements that could affect your product — for instance, new antimicrobial stewardship rules arising from the Regulation’s objective of strengthening EU action to fight antimicrobial resistance, or updated EMA templates. For companies without an internal RA team, we can effectively serve as your regulatory department; for those with a team, we act as a flexible extension, handling overflow work or specialist projects. This ensures compliance remains continuous: regulators see that even as your product portfolio grows or changes, all regulatory obligations are under active control.

Our veterinary regulatory affairs services cover all European and UK markets:

• European Union (EU) & European Economic Area (EEA): We manage applications via all EU procedures Centralised (coordinated by the EMA, where the CVMP supports the scientific assessment of quality, safety, environmental compatibility, and efficacy), Decentralised (DCP) and Mutual Recognition (MRP) (handled through the network of Member State authorities under CMDv coordination), as well as purely national routes in any EU/EEA country. A centralised marketing authorisation is issued by the European Commission and is valid across all EU states and the three EFTA states of the European Economic Area. We also handle Subsequent Recognition Procedures (SRP) to extend an existing DCP/MRP licence to additional Member States, with a duration of 30 to 90 days.
• United Kingdom: We navigate the UK’s independent system post-Brexit. This includes Great Britain (England, Scotland, Wales) where applications are submitted to the Veterinary Medicines Directorate (VMD) and Northern Ireland, where EU Regulation 2019/6 currently applies. Applicants can submit parallel applications for a new GB MA and a new NI MA in a single application, by selecting both GB and NI, provided the products are aligned (same pharmaceutical form, same qualitative and quantitative composition, same target species with the same indications, and a shared dossier). We coordinate these parallel tracks when UK-wide coverage is needed.
• Pan-European Projects: If you are targeting both the EU and UK, or if you intend to later extend a national authorisation across Europe, we factor that into your strategy from day one. Our experience includes obtaining approvals that span multiple Member States and managing referral procedures where necessary.

Regulatory timelines for veterinary medicinal products vary by procedure and product specifics. The following durations reflect the statutory assessment periods and typical overall project lengths: Procedure Key statutory period Typical overall estimate (verify internally) EU Centralised Procedure CVMP scientific assessment: 210 days of active evaluation (Article 44 of Regulation (EU) 2019/6), with a possible extension of 90 days when consultation of a reference laboratory or advisory committee is needed. The process includes a first phase of 120 days followed by clock-stop periods for applicant responses. ~12–15 months from submission to Commission Decision (confirm against current EMA performance data) Decentralised Procedure (DCP) Coordinated assessment by the Reference Member State, structured similarly to the centralised timetable with clock-stops for applicant questions. ~9–12 months (confirm internally) Mutual Recognition (MRP) 90 days statutory timetable for the mutual recognition phase ~4–6 months including pre-procedural coordination and national licence issuance Subsequent Recognition (SRP) 30 to 90 days Shortest route to add countries to an existing DCP/MRP licence UK National (VMD) The VMD applies a structured assessment timetable; specific day counts should be confirmed via VMD guidance notes ~variable Variations (VRA) Formal assessment timelines per EU variation classification guidelines ~variable

Even well-resourced companies can stumble in the complex world of veterinary regulation. We proactively steer you clear of common pitfalls:

• Incomplete Dossiers (Missing Data): A frequent error is omitting required studies or data. For example, failing to provide residue depletion studies for a food-animal product, or not including a scientific evaluation of user safety data. Where data gaps are proposed (e.g. in a Limited Market Authorisation application), these must not be critical to safety and it must be possible to mitigate any risks to an acceptable level. We audit your data package to ensure all regulatory-critical information is present, or that robust justifications are in place for any omissions for example, using published pharmacokinetic data and MRL summary reports to predict expected depletion of residues and propose appropriate withdrawal periods.
• Misjudging the Regulatory Pathway: Companies sometimes pursue the wrong authorisation route for instance, attempting a Centralised Procedure for a product that does not meet the mandatory criteria under Article 42(2) of Regulation (EU) 2019/6 (wasting time on a validation refusal), or conversely, going through multiple national submissions when a single EU procedure would be more efficient. We help you get this decision right from the start.
• Neglecting UK in the Strategy: Post-Brexit, overlooking the need for a separate GB application is a costly oversight. If a company focuses only on EU approval, it cannot sell in Great Britain. Parallel submissions are not possible for all EU procedure types for instance, they are not available for centralised, MRP, or SRP procedures due to differing timescales and procedures. We ensure parallel planning for GB (and NI) so that your launch is not limited to the EU alone.
• Poor Variation Management: Implementing changes to an approved product without regulatory clearance is a serious compliance breach. Whether it is a new API supplier, updated labelling, or revised shelf-life data, the appropriate variation category (VNRA or VRA under the new classification) must be identified and the submission made before or at the time of implementation. We establish a change control process so that no quality, safety, or efficacy change goes unreported, keeping you continuously compliant.
• Inadequate Pharmacovigilance Set-up: In the rush to launch, companies sometimes delay setting up a proper PV system. Having a veterinary pharmacovigilance system and a QPPV is a legal obligation, and if deficiencies are found during inspection, the MAH must respond with a CAPA plan. Inspections are risk-based, meaning a poor track record increases scrutiny. We integrate pharmacovigilance planning into the submission process, ensuring all PV roles, procedures, and reporting systems are operational before the product reaches the market.
• Lack of MAH Oversight on Outsourced Tasks: If you outsource pharmacovigilance, manufacturing, or regulatory tasks, inspectors expect to see active governance by the MAH. The marketing authorisation holder is responsible for the marketing of the medicinal product, and the designation of a representative does not relieve the holder of this legal responsibility. We help put in place oversight records  regular vendor audits, review of batch release documentation, periodic safety data exchanges so that at inspection time, you can demonstrate you remained in control.

Q1. What is veterinary regulatory affairs management, and why is it important?

Veterinary regulatory affairs management is the discipline of ensuring that veterinary medicinal products meet all legal and scientific requirements for authorisation and remain in compliance throughout their lifecycle. The objectives of regulatory registration are to ensure that the product is safe for the animal itself, the consumer of food derived from treated animals, those handling the product, and the environment; that the product is of consistent high quality; and that the product’s efficacy conforms with the claims made on its information leaflet and label. Without a valid marketing authorisation, no veterinary medicinal product may be placed on the market of an EU Member State, making regulatory affairs management a prerequisite for lawful market access.

 

Q2. Do I need a marketing authorisation to sell a veterinary medicinal product in the EU or UK?

Yes. Under EU pharmaceutical law, no veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted by the competent authorities of that Member State or in accordance with Regulation (EC) No 726/2004 (for centralised authorisations). This requirement is now governed by the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which replaced Directive 2001/82/EC and became applicable on 28 January 2022. In the United Kingdom, a separate national authorisation from the Veterinary Medicines Directorate (VMD) is required to sell veterinary medicines in Great Britain. Operating without a valid marketing authorisation is illegal and can result in enforcement action, so securing the proper licence is an essential first step in marketing any veterinary pharmaceutical.

 

Q3. What routes are available to authorise a veterinary medicine in Europe?

European marketing authorisation procedures for veterinary medicinal products are established by Regulation (EU) 2019/6. The centralised procedure is handled by the EMA’s Committee for Medicinal Products for Veterinary Use (CVMP), and is mandatory for certain veterinary products (e.g. those produced by specified biotechnological processes, as set out in Article 42(2) and (3) of Regulation (EU) 2019/6), while for other products it can be used optionally. The decentralised procedure (DCP) allows simultaneous applications in multiple EU Member States, with one acting as the Reference Member State to lead the assessment. The mutual recognition procedure (MRP) is used when an authorisation already granted in one Member State is recognised in one or more other Member States; its duration is 90 days. A subsequent recognition procedure (SRP) also exists, allowing recognition of an authorisation that has already gone through a DCP or MRP in one or more additional Member States, with a duration of 30 to 90 days.

 

Q4. What changed with the Veterinary Medicinal Products Regulation (EU) 2019/6?

Regulation (EU) 2019/6 updated the rules on the authorisation and use of veterinary medicines in the European Union when it became applicable on 28 January 2022, replacing Directive 2001/82/EC. Its main objectives include simplifying the regulatory environment and reducing administrative burden for pharmaceutical companies (for example, through streamlined pharmacovigilance rules), stimulating the development of innovative veterinary medicines including products for small markets, improving the functioning of the internal market, and strengthening EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals. The EMA revised its procedures and guidance documents in line with the Regulation and led the implementation of new IT systems, including the Union Product Database, which serves as a single source of information on all authorised veterinary medicines and their availability in EU Member States. This represents the most significant overhaul of the EU veterinary regulatory framework in decades.

 

Q5. How has Brexit affected veterinary medicine regulation in the UK and EU?

The EU and UK now operate distinct veterinary regulatory systems. In the EU, veterinary medicinal products continue to be regulated under a harmonised framework governed by Regulation (EU) 2019/6, with the EMA/CVMP overseeing centralised procedures and national competent authorities managing DCP, MRP, and national authorisations. The United Kingdom has its own national framework, with marketing authorisations for veterinary medicines in Great Britain issued by the Veterinary Medicines Directorate (VMD). The UK’s Veterinary Medicines Regulations 2013 (SI 2033) referenced on the Pharmafile veterinary page as coming into force on 1 October 2013 continue to form the basis of UK veterinary medicines law, though this framework can now evolve independently of EU legislation. Companies seeking to market a veterinary medicine in both the EU and UK should plan for separate regulatory submissions and approval processes in each jurisdiction.

 

Q6. What are the responsibilities of a Marketing Authorisation Holder for a veterinary medicine?

The marketing authorisation holder (MAH) is responsible for the marketing of the medicinal product, and the designation of a representative does not relieve the MAH of this legal responsibility. Key post-approval obligations include maintaining a functioning pharmacovigilance system with a designated Qualified Person for Pharmacovigilance (QPPV), keeping the product’s documentation current by submitting variations for any changes, and ensuring that manufacturing and testing remain in accordance with Good Manufacturing Practice. The MAH must also ensure the product continues to meet all safety, quality, and efficacy standards and that its labelling and patient information remain up to date. Even when specific activities are outsourced to third parties, the MAH retains overall legal accountability for the product and must demonstrate active governance over any delegated functions.

 

Q7. Is a Qualified Person for Pharmacovigilance (QPPV) required for veterinary medicinal products?

Yes. Having a veterinary pharmacovigilance system and a qualified person responsible for pharmacovigilance (QPPV) is a legal obligation for veterinary medicinal product marketing authorisation holders. The QPPV’s role is to oversee the company’s pharmacovigilance system, ensuring that any adverse events or safety concerns with the veterinary product are properly collected, evaluated, and reported to regulators. For EU authorisations the QPPV must typically reside within the European Economic Area; for UK licences a UK-based QPPV arrangement is expected. Regulatory authorities conduct inspections and checks in relation to these legal requirements and if deficiencies are found in the pharmacovigilance system, they are documented in the inspection report, and the MAH must respond with a corrective and preventive action (CAPA) plan.

 

Q8. What pharmacovigilance obligations apply after a veterinary medicine is approved?

Once a veterinary medicine is on the market, the MAH must implement continuous safety monitoring. This includes systematically collecting reports of adverse events observed in treated animals (or humans in case of accidental exposure), investigating safety signals, and promptly reporting significant findings to the relevant authority. Inspections may be performed either on site or remotely, and if major gaps are found in the pharmacovigilance system during an inspection, a re-inspection will be performed. The frequency of inspection for each MAH is risk-based it could be based on the quality of the reports submitted or the quality of the signal management process. Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81, Articles 123 and 126) describes the rules relating to the monitoring of veterinary medicines, with further detail in the Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices.

 

Q9. What data is required in a veterinary medicinal product marketing authorisation application?

A veterinary medicine application must contain a comprehensive dossier demonstrating the product’s quality, safety, and efficacy. The quality section includes detailed information on the product’s composition, manufacturing process, and quality control testing, ensuring the product is of consistent high quality, does not deteriorate, and has the stability to last at least until the expiry date. The safety section provides evidence that the product is safe for the target animal, safe for people handling the product, safe for consumers of food derived from treated animals, and safe for the environment. The efficacy section contains study data showing that the product’s efficacy conforms with the claims made on its information leaflet and label. All data is assembled in a structured format (such as the VNeeS electronic submission format) according to EU and national authority guidelines, enabling regulators to assess whether the veterinary product meets all required standards.

 

Q10. What is a Maximum Residue Limit (MRL), and why does it matter for veterinary medicines?

A Maximum Residue Limit (MRL) is the highest concentration allowed for a residue in a food product obtained from an animal that has received a veterinary medicine or that has been exposed to a biocidal product used to control germs or pests affecting animals. EU law requires that foodstuffs such as meat, milk, or eggs do not contain residue levels of veterinary medicines or biocidal products that may represent a hazard to consumer health. The EMA’s Committee for Veterinary Medicinal Products (CVMP) is responsible for recommending MRLs, which become legally binding food safety standards when adopted by the European Commission. Regulation (EC) No 470/2009 lays down the rules and procedures to establish MRLs. For any veterinary medicine intended for food-producing animals, the active substances must have an established MRL (or be explicitly exempt), and a suitable withdrawal period will be specified to ensure residues fall below the MRL before the animal enters the food chain.

Q11. Are there different regulatory requirements for veterinary medicines for pets compared with food-producing animals?

The fundamental requirements for authorisation demonstrating product quality, safety, and efficacy apply to all veterinary medicinal products regardless of species. However, medicines for food-producing animals have additional regulatory requirements designed to protect the food supply. The registration process must ensure the product is safe not only for the animal itself but also for the consumer of food derived from treated animals, those handling the product, and the environment. This means food-animal products require assessment of drug residues in edible tissues, resulting in established Maximum Residue Limits (MRLs) and mandated withdrawal periods the time between last treatment and when the animal may be used for food production. In contrast, medicines for companion animals do not require MRL studies or withdrawal periods (since those animals do not enter the food chain) but must still meet the same rigorous standards of safety, quality, and efficacy before they can be authorised and marketed.

 

Q12. Are electronic (VNeeS) submissions mandatory for veterinary medicine applications?

Yes. From 28 January 2022, electronic submissions are mandatory for veterinary applications in line with Article 6(3) of Regulation (EU) 2019/6. In the EU, the accepted format is the VNeeS (Veterinary Non-eCTD electronic Submission) a set of electronic files organised into module folders containing PDF or MS Word files, as per European guidance. The Irish Health Products Regulatory Authority (HPRA), for example, accepts submissions in VNeeS format without paper copies, or through the Common European Submission Platform (CESP) available on the HMA website. The HPRA is not in a position to accept other electronic formats, and companies with specific difficulties should contact the authority directly before making an application. All submission types including new applications for centralised, decentralised, mutual recognition and national procedures, variations, renewals, line extensions, and responses to assessment questions are accepted in VNeeS format.

 

Q13. What is a variation to a veterinary marketing authorisation, and how are they classified?

A variation is an official change to the terms of an existing marketing authorisation for a veterinary medicinal product. After a product is authorised, any modification whether to the manufacturing process, formulation, labelling, shelf life, or therapeutic indications must be submitted to the relevant regulatory authority as a variation. Under Regulation (EU) 2019/6, variations are classified into two broad categories: Variations Not Requiring Assessment (VNRA), which are minor changes that can be notified without prior regulatory approval, as governed by Commission Implementing Regulation (EU) 2021/17; and Variations Requiring Assessment (VRA), which are more substantial changes that require formal review and regulatory approval before implementation, as detailed in EMA-CMDv guidance on the classification of variations according to Article 62 of Regulation (EU) 2019/6. By managing variations promptly and correctly, the MAH ensures that the product on the market always conforms to its approved specifications and that regulatory authorities have current information about the product.

 

Q14. Does a veterinary marketing authorisation expire or require renewal?

Under the latest EU veterinary legislation, a marketing authorisation is initially granted with a five-year validity period. After this period, rather than requiring a formal renewal assessment, the MAH can confirm to the Agency that they wish the marketing authorisation to become unlimited in duration; if confirmed, the European Commission takes the necessary steps to make it so. If the MAH replies in the negative or does not respond, the marketing authorisation will automatically expire after the five-year period. No assessment is involved in the administrative removal of the five-year time limit, and no fee is payable for this administrative amendment. It is important to note that even with an indefinite authorisation, regulators retain the power to review, suspend, or revoke an authorisation if serious safety or compliance issues arise.

 

Q15. What is Pharmafile’s experience in veterinary regulatory affairs?

Pharmafile offers tailored solutions in the area of global quality management to international standards and has a well-established veterinary regulatory affairs service. Across its broader regulatory practice, Pharmafile has achieved more than 1,000 product approvals through National, MR, and DC procedures across Europe, drawing on 30 years of experience in the pharmaceutical industry. Pharmafile’s active engagement with the veterinary regulatory landscape is demonstrated by its close monitoring of CVMP activities, including tracking positive opinions for new marketing authorisations and variations for veterinary medicines across species such as cattle, dogs, pigs, and cats. The regulatory registration process described on Pharmafile’s veterinary page traces its origins to the 1965 EC Medicines Directive and covers the full evolution of EU veterinary legislation, including the key Directives 2001/82/EC, 2004/28/EC, and 2009/53/EC. This depth of regulatory knowledge supports companies seeking to navigate both EU and UK veterinary regulatory requirements efficiently and compliantly.

To support a comprehensive solution, we integrate veterinary regulatory affairs services with other key offerings:

• Pharmacovigilance Services – Turnkey drug safety monitoring for both human and veterinary products. We provide veterinary QPPV services, establish adverse event collection processes, and ensure compliance with EU and UK PV requirements. This pairs with Regulatory Affairs to cover the full post-marketing safety obligations.
• Quality & GMP Compliance – Advisory and audit services ensuring that manufacturing and testing adhere to Good Manufacturing Practice. For veterinary products, GMP oversight is critical (especially when using multiple contract manufacturers). We perform vendor qualifications and compliance checks that feed directly into regulatory submissions and satisfy inspectors that quality systems are robust.
• eCTD & Electronic Submission Support – While veterinary submissions use VNeeS, our team also manages eCTD for human medicines and related electronic formats. If your company has both human and veterinary portfolios, we provide a unified approach to all electronic regulatory transactions. We stay at the forefront of e-submission changes such as future updates to VNeeS specifications or transitions to new EU submission portals so you are never caught off-guard by technical requirements.
• Regulatory Affairs (Human Medicinal Products) – Many principles overlap between human and veterinary regulation. If you also develop human medicines, our Regulatory Affairs Management service (covering EMA, MHRA, and national competent authorities) follows the same structured approach.
• Regulatory Outsourcing – For companies that need to delegate specific tasks or fill temporary resource gaps, we provide flexible outsourcing arrangements, from undertaking entire regulatory requirements to performing specific tasks during periods of increased workload or staff vacancies.
• Knowledge Centre – We publish explanatory articles and briefings on regulatory topics, including updates on CVMP activities and evolving EU/UK veterinary regulatory requirements, to help clients stay informed of developments that may affect their products.