Herbal Vigilance – Safety & Compliance for Herbal Medicinal Products

Comprehensive pharmacovigilance support for herbal medicinal products, ranging from Traditional Herbal Registrations (THRs) to well-established herbal medicines, as well as borderline herbal products where medicinal and supplemental categories overlap. The marketing authorisation holder for a medicinal product (herbal medicinal products, certain medicinal products for external use or natural remedies) or the registration holder for a traditional herbal medicinal product must operate a pharmacovigilance system. For other herbal medicinal products not falling within the scope of the traditional use registration, the requirements to operate a pharmacovigilance system, to prepare, maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system apply. The EU’s Committee on Herbal Medicinal Products (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, while the UK’s MHRA retains responsibility for pharmacovigilance across the UK. As all THR registrations will be based on 30 years’ safe use, Marketing Authorisation Holders (MAHs) for the majority of registered herbal products will be requested to submit PSURs on a three-yearly cycle. However, more frequent PSURs may be required for some registered products. Pharmafile PV’s Herbal Vigilance service helps you meet and exceed these requirements ensuring effective safety monitoring that protects patients and secures regulatory compliance in both the EU and UK.

Our Herbal Vigilance service benefits:

• Herbal Medicinal Product Marketing Authorisation Holders (MAHs): Companies holding full marketing authorisations or traditional registrations for herbal medicines in the EU or UK. Whether you market herbal remedies under a Traditional Herbal Registration (THR) (e.g. herbal teas, tinctures, capsules registered for traditional use) or herbal products with full marketing authorisations (often based on well-established medicinal use), you are obliged to adhere to pharmacovigilance requirements. According to the Human Medicines Regulations (2012), a product is a herbal medicinal product if the active ingredients are herbal substances and/or herbal preparations only. In certain circumstances, vitamins and minerals may be added to the product provided that their action is ancillary to that of the herbal active ingredients regarding the specific claimed indication(s). We assist MAHs that may not have large in-house PV teams by acting as an outsourced vigilance department. We ensure you have a functioning pharmacovigilance system  even though applicants for, and holders of, simplified registrations of traditional herbal medicinal products are not required to submit a pharmacovigilance system summary, each is required to operate a pharmacovigilance system and prepare, maintain and make available on request a pharmacovigilance system master file. For fully licensed herbal medicines (approved via well-established use or full marketing authorisation), the full spectrum of PV obligations applies, including the requirement to submit a summary of the pharmacovigilance system.
• Manufacturers of Borderline Herbal Products: Businesses producing herbal products on the cusp between medicines and supplements  for instance, high-dose herbal capsules marketed as food supplements, or traditional remedies that could be considered natural health products. Such products may not require a THR if no medicinal claims are made, but safety monitoring remains crucial. We help implement appropriate safety monitoring to capture any adverse effects or quality issues from these products. We also guide you in determining whether a product should be classified and registered as a medicine or can remain a supplement. By ensuring correct classification and thorough safety oversight, we protect you from regulatory action and ensure consumer safety regardless of classification.
• Herbal Product Companies Seeking Enhanced PV Compliance: Established manufacturers of herbal medicines who wish to strengthen their pharmacovigilance practices  perhaps after a regulatory inspection, audit, or an internal review  can benefit from our expertise. We support companies that have historically relied on the inherent safety of traditional remedies but now face regulators who demand rigorous documentation and proactive safety monitoring. We also collaborate with companies managing large portfolios of herbal and homeopathic products to ensure consistent vigilance standards across all products, supporting any needed contributions to PSURs and safety communications.

(Note: Our herbal vigilance services provide end-to-end support for fulfilling regulatory requirements, but the legal responsibility to comply with pharmacovigilance obligations remains with the marketing authorisation or registration holder. We act on your behalf and under your oversight to ensure you meet these obligations and uphold patient safety).

Diverse Regulatory Pathways (THR vs Full MA vs Homeopathics): Herbal medicinal products can be authorised via different routes, each with distinct pharmacovigilance expectations:

• Traditional Herbal Registrations (THR): Products registered under the traditional use provisions enjoy a simplified pathway based on long-standing traditional use. While applicants for, and holders of, simplified registrations of traditional herbal medicinal products are not required to submit a pharmacovigilance system summary, each is required to operate a pharmacovigilance system and prepare, maintain and make available on request a pharmacovigilance system master file. A common challenge is that many THR holders (often small companies) underestimate this requirement, thinking their obligations are limited. We set up and manage the necessary PV system  ensuring compliance with requirements to collect and evaluate ICSRs, submit any necessary expedited reports and PSURs (which for most THRs are due on a three-year cycle).
• Herbal Medicines with Full MAs: For other herbal medicinal products, not falling within the scope of the traditional use registration, the requirements to operate a pharmacovigilance system, to prepare, maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system apply. These products are regulated like any other medicine the challenge is ensuring that the pharmacovigilance of your herbal MAs is integrated seamlessly into your PV system with full compliance with Good Pharmacovigilance Practices (GVP). The GVP modules will remain in force in the UK, supplemented by a guidance note on the exceptions and modifications to the EU guidance on good vigilance practices that apply to UK MAHs.
• Homeopathic Remedies: For homeopathic medicinal products registered via the simplified registration procedure, the requirements to operate a pharmacovigilance system, to maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system do not apply. However, for other homeopathic medicinal products, not falling within the scope of the simplified registration, the requirements to operate a pharmacovigilance system, to prepare, maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system apply. Products authorised through marketing authorisations under the Homoeopathic National Rules scheme are covered by the Windsor Framework  from 1 January 2025 the MHRA will only authorise products through National Rules on a UK-wide basis.

Signal Detection in Largely “Safe” Products: Herbal medicines often have a long tradition of safe use, which can lead companies to be less vigilant. However, authorities absolutely expect that MAHs actively monitor for new signals. MAHs’ signal detection systems need to enable them to meet their requirements for cumulative signal detection across all available data sources. The MHRA does not require MAHs to conduct signal detection against the MHRA’s own database, as it will make relevant UK data available for inclusion in MAHs’ systems. A challenge is that spontaneous ADR reporting for herbals might be lower (due to under-reporting or attribution issues), making signal detection harder. We mitigate this by broadening the search: reviewing literature and real-world studies, monitoring toxicology updates, and engaging with international herbal safety databases. For all products authorised in the UK, MAHs are obliged to notify the MHRA of new information arising from any data source (except the MHRA’s database) which impacts the marketing authorisation  this includes standalone signal notifications submitted to the EMA that are relevant to UK products as well as signals raised by the EMA.

UK and EU Post-Brexit Divergence for Herbal Products: Companies now face dual regulatory regimes. Registration of traditional herbal medicines falls outside the scope of the Windsor Framework and is therefore not impacted the provisions introduced from 1 January 2021 when the UK left the EU still apply. In Great Britain (for products with the prefix THR GB), the Human Medicines Regulations 2012 (as amended) has the provision to accept 15 years of traditional use evidence from a wider range of countries in addition to EU/EEA countries, provided they have a level of pharmacovigilance equivalent to that of the UK. However, these provisions do not apply to traditional herbal medicines intended to be marketed in Northern Ireland. For Northern Ireland, traditional use evidence should be provided that the product has been used for a period of 15 years in the EU/EEA, and only the EU List will be applicable for applicants wanting to apply to market a UK-wide traditional herbal medicine. We help you navigate these dual requirements, ensuring that your pharmacovigilance system and documentation satisfy both EU and UK authorities simultaneously.

Borderline Misclassification & Herbals as Foods: We often see confusion about whether a product should be a licensed herbal medicine or simply a food supplement with herbal ingredients. Misclassification can be risky: selling a product with a supposed therapeutic effect under food laws can draw enforcement for selling an unlicensed medicine, while registering a product as a traditional herbal medicine brings obligations that some companies are unprepared for (like PV and GMP standards). We help you clearly define and document the status of your product and set up the appropriate vigilance measures.

Post-Registration Commitments & Monitoring: Obtaining the registration is not the end herbal products are subject to pharmacovigilance and periodic review just like conventional medicines. For medicines authorised nationally in the UK, the MAH is required to submit pharmacovigilance data to the MHRA, including: UK and non-UK Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and Post-Authorisation Safety Studies (PASS) protocols and final study reports. MAHs are also reminded that they are responsible for ensuring that the information for their product is kept up to date with current scientific knowledge, including checking the MHRA website, the EMA and HMA websites for the outcome of procedures which affect product information.

Regulatory bodies in the EU and UK hold herbal medicine manufacturers to high pharmacovigilance standards, analogous to those for conventional pharmaceuticals:

• Functioning Pharmacovigilance System: The marketing authorisation holder for a medicinal product (herbal medicinal products, certain medicinal products for external use or natural remedies) or the registration holder for a traditional herbal medicinal product must operate a pharmacovigilance system. The one administrative concession is that applicants for, and holders of, simplified registrations of traditional herbal medicinal products are not required to submit a pharmacovigilance system summary, however, each is required to operate a pharmacovigilance system and prepare, maintain and make available on request a pharmacovigilance system master file. For herbal products with full marketing authorisations (e.g. well-established use authorisations or specific indications beyond “traditional use”), all standard PV requirements apply  including preparing and maintaining a PSMF, operating a PV system, and submitting a pharmacovigilance system summary.
• Diligent Adverse Reaction Reporting & Periodic Safety Updates: Herbal product manufacturers must collect and evaluate all adverse drug reactions (ADRs) and submit them as ICSRs to relevant authorities. In the UK, the MHRA requires submission of all UK (including Northern Ireland) ICSRs (serious and non-serious) and serious ICSRs from other countries via the MHRA Gateway and/or ICSR Submissions portal. For products placed on the market in Northern Ireland, MAHs should continue to submit ICSRs according to EU requirements to the EudraVigilance database including all serious reports from the UK and other countries and non-serious reports that occur in the EEA or in Northern Ireland. As all THR registrations will be based on 30 years’ safe use, MAHs for the majority of registered herbal products will be requested to submit PSURs on a three-yearly cycle. However, more frequent PSURs may be required for some registered products. These will be assessed taking into account all relevant information and decisions will be made reflecting UK clinical practice to best support patient safety in the UK.
• Active Signal & Risk Management: Regulators require MAHs to continuously evaluate safety signals and manage risks. Signal detection systems need to enable MAHs to meet requirements for cumulative signal detection across all available data sources. The MHRA will carry out assessment of signals and issue decisions for signals identified by the MHRA as well as those highlighted internationally. MAHs are obliged to notify the MHRA of emerging safety issues within 3 working days after establishing that a signal or a safety issue from any source meets the definition of an emerging safety issue. For validated signals, MAHs should inform the MHRA once validated, and validation should include a thorough analysis of ICSR data available and be complemented by an assessment of other relevant information including whether the risk is addressed in other UK-authorised products. If a PSUR is due to be submitted within 6 months of the completion of the signal assessment, the signal should be reported in the PSUR, and a separate standalone signal notification is not required unless the MHRA advises otherwise  however, if the PSUR includes a signal that corresponds to an important risk, the MHRA should be notified separately at the time of submission.
• Continuous Benefit-Risk Monitoring: MAHs are obliged to notify the MHRA of any information that might influence the evaluation of the benefits and risks of their product as soon as is reasonably practicable, including where the use of the product is restricted in any country  this is particularly important where any new information may potentially impact the clinical management of patients, including where proactive communications to healthcare professionals may be required.
• Seamless Pharmacovigilance Integration for Mixed Portfolios: Many herbal product companies may also deal in conventional pharmaceuticals, cosmetics, or food supplements. Regulators expect that the pharmacovigilance system covers the entire range of medicinal products, herbal or not, and that safety information flows properly even for borderline products. The GVP modules apply to herbal medicines just as to any medicinal product. At inspections, regulators often focus on whether companies treat herbal pharmacovigilance with the same rigour  looking for the presence of standard operating procedures, qualified staff, and evidence of safety data being collected and reviewed.

We provide end-to-end herbal pharmacovigilance services integrated into your operations, ensuring no safety issue goes unnoticed and all regulatory obligations are met:

We begin with a detailed regulatory compliance strategy tailored to herbal medicines:

• Pharmacovigilance System Setup: We establish a GVP-compliant system for your herbal medicinal products. For Traditional Herbal Registrations (THRs): we create a fit-for-purpose PV system that satisfies the simplified registration conditions. We ensure you have a Pharmacovigilance System Master File (PSMF) even though a summary does not need to be submitted to regulators at application time  each THR holder is still required to operate a pharmacovigilance system and prepare, maintain and make available on request a PSMF. For fully licensed herbal medicines (approved via well-established use or full marketing authorisation), the full requirements apply, including submission of the pharmacovigilance system summary. We align with HMPC guidelines and national regulations in both the EU and UK.
• Herbal Safety Specification & PSUR Planning: We plan for regulatory expectations, including PSURs: for most THR products, PSURs are requested on a three-yearly cycle due to being based on long-standing safe use. We track these schedules and prepare insightful PSURs that reflect any new data, even if the product’s safety profile seems well-established. Through our active surveillance (including literature review of herbal safety studies), we feed in any incremental knowledge on your product’s safety or interactions to keep your risk understanding current.
• Homeopathic and Borderline Product Strategy: Within the scope of herbal vigilance, we also account for homeopathic medicinal products if needed:
  • For simplified registered homeopathics (no indications, highly dilute), the requirements to operate a pharmacovigilance system, to maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system do not apply. However, if any safety issues arise, we facilitate voluntary vigilance and assist in determining if escalation is required.
  • For other homeopathic medicinal products, not falling within the scope of the simplified registration, the full requirements to operate a pharmacovigilance system apply. Products authorised through the Homoeopathic National Rules scheme are covered by the Windsor Framework  from 1 January 2025 the MHRA will only authorise products through National Rules on a UK-wide basis. For herbal supplements (regulated as foods), we coordinate with our Nutraceuticals vigilance team to ensure any potential signals in that space are evaluated for whether they indicate a need to consider reclassification or additional warnings.

We manage the entire lifecycle of adverse event (AE) handling for herbal products; from the moment a report is received to its closure:

• Centralised AE Intake for All Sources: We implement mechanisms for collecting adverse reactions related to your herbal medicines through every possible channel: healthcare professional reports, consumer reports, medical information and customer service (training your teams to recognise when an inquiry or complaint might contain information about an adverse effect or quality issue), and quality complaints (particularly important for herbal safety issues, which can arise from quality problems such as contamination or misidentification of herbs).
• Case Triage & Processing: Upon receiving an adverse event report, our vigilance specialists immediately classify it by seriousness and expectedness. We prepare and submit Individual Case Safety Reports (ICSRs) to regulators within required timelines. In the UK, the MHRA requires submission of all UK ICSRs (serious and non-serious) and serious ICSRs from other countries via the MHRA Gateway and/or ICSR Submissions portal. For products placed on the market in Northern Ireland, we continue to submit ICSRs according to EU requirements to the EudraVigilance database  using the country code “XI” in the field primary source country for regulatory purposes for cases relating to Northern Ireland. In the EU, serious cases go to EudraVigilance via national authorities. We ensure no case falls through the cracks  we handle follow-up on cases seamlessly, reaching out for additional information with sensitivity to the context of herbal products (e.g., verifying if the patient was also on conventional drugs that could have caused an interaction).
• Data Management & PSMF Documentation: All case processing activities, from initial receipt to submission dates, are documented and stored in a secure database. The PSMF we maintain for you contains a section on the herbal product specifics (for example, any special national requirements, like the three-year PSUR cycle for THRs, or any additional monitoring commitments). We update the PSMF with any changes.

Our team employs rigorous techniques to identify and address safety signals for herbal medicines:

• Proactive Signal Monitoring: We periodically perform signal detection on cumulative safety data of your herbal products. Signal detection systems need to enable you to meet requirements for cumulative signal detection across all available data sources. For products with higher case volumes, we employ statistical tools (disproportionality analyses) to detect unexpected reporting patterns; for those with lower volumes, we focus on in-depth clinical review of cases and emerging literature. The MHRA does not require MAHs to conduct signal detection against its own database, as it will make relevant UK data available for inclusion in MAHs’ systems. We monitor scientific literature, pharmacovigilance databases, and international herbal safety data.
• Signal Notification & Regulatory Communication: When a signal is identified and validated, we manage regulatory notification. MAHs are obliged to notify the MHRA of emerging safety issues within 3 working days after establishing that a signal meets the definition of an emerging safety issue. For validated signals that require action, where the MAH concludes there is a new or changed risk requiring a change to the product information and/or Risk Management Plan, a variation application should be submitted in this case a separate standalone signal notification is not required as the proposed changes and supportive evidence will be assessed within the variation procedure. Where a variation to address a signal has been submitted to the EU and affects products authorised in the UK, the variation should also be submitted to the MHRA. We coordinate these multi-jurisdictional submissions on your behalf.
• Implementing Risk Minimisation Measures: If a safety signal is confirmed, we help develop and implement risk minimisation: updating your patient information leaflet (PIL) and Summary of Product Characteristics (SmPC) to include new warnings or contraindications, communicating with healthcare professionals if urgent, and changing packaging or labelling to mitigate misuse. In extreme cases, we coordinate with regulators on product recalls or withdrawals.

We ensure that your herbal pharmacovigilance activities are not siloed but rather integrate with all other relevant functions:

• Medical Information & Customer Feedback Loops: We link our Herbal Vigilance service with your Medical Information service. If a patient or herbal practitioner contacts the medical information line with a concern about a possible side effect or a question hinting at a safety issue, this is immediately shared with the PV team. This ensures no safety signal is missed simply because it came through a customer service channel.
• Quality & Manufacturing Synergy: Herbal products can have quality variations affecting safety  e.g., variable alkaloid content, contamination with heavy metals, or misidentification of plant species. We coordinate closely with your Quality Assurance (QA) and manufacturing teams. If our vigilance process picks up a pattern of issues that point to a quality defect, we promptly loop in QA to investigate. Conversely, if the QC team finds an impurity or labelling error that could pose a safety risk, we treat it as a potential safety issue to evaluate and possibly report to regulators. MAHs are obliged to notify the MHRA of any information that might influence the evaluation of the benefits and risks of their product as soon as is reasonably practicable.
• Governance & Compliance Oversight: We help establish or enhance your internal pharmacovigilance governance specifically for herbal products. This includes regular Safety Review Team meetings focusing on herbal product safety, where our experts present analyses of new adverse cases, regulatory changes (like HMPC monograph revisions or new MHRA guidance), and progress on any open safety actions. We also conduct internal audits to prepare you  checking your PSMF for completeness (it must be available on request even for THRs), reviewing your adverse event files, and making sure your responsible person for pharmacovigilance is properly documented. We ensure that PSURs are produced on time and to high quality  for most THR products, this means every three years, although more frequent PSURs may be required for some products.

Our specialized focus on herbal pharmacovigilance allows us to pre-empt and correct many issues before regulators or inspectors flag them:

• Inadequate PV Systems for THRs: A common inspection finding is that companies holding Traditional Herbal Registrations assume that reduced registration data requirements mean reduced PV obligations. Inspectors frequently find that small herbal companies lack a formal PV system  no designated PV officer, no PSMF, and no ADR collection process. We eliminate this pitfall by setting up a proportionate yet compliant PV system for THRs. Applicants for, and holders of, simplified registrations of traditional herbal medicinal products are not required to submit a pharmacovigilance system summary, however, each is required to operate a pharmacovigilance system and prepare, maintain and make available on request a pharmacovigilance system master file. We document everything so that if inspectors visit, you can show SOPs for handling safety information, training records, and a maintained PSMF.
• Missed or Late PSURs: Since THR products rely on the premise of long-standing safe use, some companies mistakenly believe ongoing periodic reporting is not critical. However, regulators do require PSURs. As all THR registrations will be based on 30 years’ safe use, MAHs for the majority of registered herbal products will be requested to submit PSURs on a three-yearly cycle. More frequent PSURs may be required for some registered products. We diarise PSUR due dates, compile the reports, and submit them on time.
• Assuming “Natural” Means No Need for Vigilance: We often encounter companies thinking that because their products are natural or have decades of use, they do not need active pharmacovigilance. Regulators fundamentally disagree  the marketing authorisation holder for a herbal medicinal product or the registration holder for a traditional herbal medicinal product must operate a pharmacovigilance system. One consequence of this misconception is that adverse events go uncollected or unanalysed. We address this by fostering a safety culture: implementing a straightforward adverse event reporting process for your customer-facing teams and third-party distributors, so everyone knows how to spot and forward a potential problem.
• Poor Coordination Between Herbal and General PV: If you have both conventional medicines and herbal products, another pitfall is separating their PV processes. This can lead to duplicative effort or missed signals. We ensure an integrated approach: one PSMF that covers herbal and non-herbal portfolios (with special sections as needed), one safety database for all ICSRs regardless of origin, and unified oversight. This approach not only satisfies regulators but also improves safety surveillance.
• Documentation & PSMF Gaps for Herbals: Some herbal MAHs have faced critical findings for lacking documentation  e.g., no record of risk management decisions, or an out-of-date PSMF. We continuously update your PSMF to reflect your herbal portfolio and maintain a complete audit trail of all safety decisions for herbal products. This way, during an inspection, every response about your herbal product’s safety management can be backed up with written evidence.
• Failing to Update Product Information with Current Scientific Knowledge: MAHs are responsible for ensuring that the information for their product is kept up to date with current scientific knowledge, including checking the MHRA website, the EMA and HMA websites for the outcome of procedures which affect the product information and, unless advised otherwise, implementing updates to the product information in the UK via the appropriate variation application. Companies that fail to keep SPCs and PILs current risk enforcement action.

Our herbal vigilance services cover regulatory requirements in both the European Union and the United Kingdom:

• European Union (and EEA): We ensure full compliance with EU pharmacovigilance regulations for herbal medicinal products. This includes establishing and maintaining PV systems compliant with GVP modules, submitting ICSRs to EudraVigilance, preparing PSURs, and engaging with the HMPC, which issues scientific opinions on herbal substances and preparations along with information on recommended uses and safe conditions. Whether your product is a THR or a full MA herbal product, we ensure the appropriate level of vigilance is maintained across all EU/EEA countries.
• United Kingdom: We cover Great Britain (England, Scotland, Wales) and Northern Ireland. The MHRA retains responsibility for Pharmacovigilance across the UK. There are some different requirements for products placed on the market with respect to Great Britain and Northern Ireland:
  • For Great Britain, the provisions introduced from 1 January 2021 apply for THR products. GB-only THR registrations (prefix THR GB) benefit from the provision to accept 15 years of traditional use evidence from a wider range of countries in addition to EU/EEA countries, provided they have a level of pharmacovigilance equivalent to that of the UK. The MHRA may also publish its own list of herbal substances, preparations and combinations for use in traditional herbal medicines.
  • For Northern Ireland, EU pharmacovigilance requirements continue to apply in addition to UK requirements. The wider-country provisions for traditional use evidence do not apply to traditional herbal medicines intended to be marketed in Northern Ireland. For NI and UK-wide THR products, traditional use evidence should be provided for a period of 15 years in the EU/EEA, and only the EU List applies.
  • For products authorised for use in Northern Ireland, MAHs should continue to submit ICSRs according to EU requirements to the EudraVigilance database, using the country code “XI” in the field primary source country for regulatory purposes.
  • Registration of traditional herbal medicines falls outside the scope of the Windsor Framework and is therefore not impacted  the provisions introduced from 1 January 2021 when the UK left the EU still apply.
• Global Alignment: While our main focus is EU and UK, our herbal pharmacovigilance practices follow the principles of international standards. We can support harmonisation of pharmacovigilance across different regions.

Herbal pharmacovigilance activities follow regulatory timelines with some nuances specific to the herbal sector. Below are typical timelines and schedules:

(These timelines are guidelines. Our team is structured to handle unexpected situations on short notice. Verify all estimates against current internal performance data before publication.)

By leveraging our expertise, we help your company avoid common herbal pharmacovigilance pitfalls:

• Misjudging the Product Category: A frequent error is claiming “It’s just a supplement, so we don’t need PV,” while simultaneously implying medicinal effects in marketing. Under the Human Medicines Regulations (2012), a product is a herbal medicinal product if the active ingredients are herbal substances and/or herbal preparations only. If a product makes medicinal claims, it is likely a herbal medicine requiring a THR or MA and with that comes PV obligations. We prevent this by either fully committing the product to the medicines route (with proper approval and PV system) or clearly positioning it within the supplement category with adjusted claims.
• Insufficient Pharmacovigilance for THR Products: Companies sometimes submit THR dossiers without adequately establishing their PV systems, perhaps assuming that the simplified registration pathway means simplified PV. While a PV system summary does not need to be submitted, each THR holder is required to operate a pharmacovigilance system and prepare, maintain and make available on request a PSMF. Failure to have these in place is a compliance breach.
• Missing PSUR Deadlines: Companies that assume their product’s long safety record eliminates the need for periodic reporting are mistaken. As all THR registrations will be based on 30 years’ safe use, PSURs are requested on a three-yearly cycle, and more frequent PSURs may be required. Not filing PSURs when required can jeopardise your licence. We diarise all PSUR deadlines and ensure timely completion.
• Neglecting Signal Detection and Notification Obligations: Herbal product companies sometimes lack formal signal management processes. MAHs are obliged to notify the MHRA of emerging safety issues within 3 working days of recognition, and for all products authorised in the UK, MAHs must notify of new information from any data source that impacts the marketing authorisation, including standalone signal notifications submitted to the EMA that are relevant to UK products. We implement robust signal detection procedures and ensure all notifications are made within required timescales.
• Ignoring Regulatory Updates: Herbal medicinal regulations evolve. For example, the Windsor Framework arrangements took effect for human medicines from 1 January 2025, though THR registrations fall outside its scope and remain governed by the provisions from 1 January 2021. Companies that do not keep track of such changes risk non-compliance. We keep track of all regulatory developments and transitioned clients through Brexit seamlessly.
• Inadequate Documentation of Manufacturing & Supply Chain: Herbal products often involve multiple suppliers (growers, extract manufacturers). A mistake is failing to maintain proper documentation from each source. Quality issues (contamination, adulteration) are a known risk with herbal raw materials and can trigger both quality complaints and adverse event reports. We help set up and document quality assurance measures that support both your PV and quality systems.
• Treating Herbal PV in Isolation from General PV: If you have both conventional medicines and herbal products, running separate PV processes can lead to gaps. We integrate herbal vigilance into your overall PV framework, ensuring consistent processes and the ability to detect cross-product signals (such as herb-drug interactions between your herbal and conventional products).

Ensuring the safety of herbal medicinal products often intersects with other areas of regulation and practice. We provide a holistic suite of services that complement Herbal Vigilance:

• Pharmacovigilance Services: For companies that also market conventional pharmaceuticals, our comprehensive Pharmacovigilance Services integrate seamlessly with Herbal Vigilance. We can manage a unified PV system covering all your medicines  synthetic, biological, or herbal  avoiding duplication and ensuring no safety signal is missed. (See our Pharmacovigilance Services page for details on our full-range PV offering).
• Nutraceuticals: If you produce herbal supplements regulated as foods, our Nutraceuticals service handles safety and compliance for those products. It coordinates closely with Herbal Vigilance to manage borderline product issues and ensures appropriate safety monitoring for non-medicinal herbal products. This way, whether a product is legally a medicine or a supplement, safety data is captured and assessed. (Refer to our Nutraceuticals service page for more on food supplement compliance and safety monitoring).
• Quality Services: Our Quality Assurance (QA) Services help maintain good manufacturing practice (GMP) and quality control for herbal products. Many herbal safety issues originate from quality problems (e.g., adulteration or contamination). By ensuring robust GMP for herbals, including sourcing checks for herbal raw materials and appropriate testing, we help prevent quality-related safety issues from occurring. (See our Quality Services page for how we support GMP and quality systems).
• Regulatory Affairs (Herbal Registrations): If you need to register new herbal medicines, our Regulatory Affairs Management service guides you through THR applications (compiling traditional use evidence, preparing the CTD) or full marketing authorisation submissions for herbal products. A well-planned registration can pre-empt many PV issues (e.g., by ensuring the product has appropriate contraindications from the start). (Refer to Herbal Products service page for our expertise in Traditional Herbal Medicine Registration).
• Medical Information: Our Medical Information Services team can serve as the front-line for both your herbal medicines and any related healthcare queries. Often, these teams receive the first insight into safety concerns from patient calls. By linking them with Herbal Vigilance, we create an efficient feedback loop between customer queries and safety management. (See Medical Information service page for how we handle consumer and HCP inquiries).
• QPPV Services: Our experienced QPPVs provide oversight for herbal medicinal products as part of our broader QPPV service offering. (See our QPPV Services page for details on outsourced Qualified Person for Pharmacovigilance provision).
• Training & Auditing: We offer targeted training sessions for your staff on herbal pharmacovigilance responsibilities and the importance of reporting. Additionally, our team can perform pharmacovigilance audits on your herbal medicinal product operations, helping you prepare for regulatory inspections by identifying and rectifying any gaps in your PV system before authorities do.