Cosmetovigilance – EU & UK Cosmetic Product Safety & Surveillance

Cosmetovigilance is the collection, evaluation, and monitoring of spontaneous reports of undesirable events observed during or after the normal or reasonably foreseeable use of a cosmetic product. Together with other tools, cosmetovigilance contributes to post-market surveillance. The responsibility for cosmetovigilance lies with the product’s designated Responsible Person (RP), who must continuously monitor and record such effects and regularly re-assess the risk associated with them. Since July 2013, when the European Cosmetics Directive was replaced by Regulation (EC) No. 1223/2009, even cosmetic product distributors have a legal obligation to notify authorities about Serious Undesirable Effects (SUEs) occurring in Europe to the local competent authority. Cosmetic adverse event reporting in the EU is governed by a harmonised regulatory framework designed to protect consumer health and ensure product safety across Member States, achieved primarily through Regulation (EC) No. 1223/2009 and the implementation of standardised SUE Reporting Guidelines. Our team assists the Responsible Person in meeting all regulatory, compliance, and safety obligations for cosmetic products  from setting up robust cosmetovigilance systems to handling SUE reports and ensuring full post-market safety compliance.

This service is tailored to:

• Cosmetic and Personal Care Product Brands & Manufacturers: Companies that place cosmetic products on the EU and/or UK market and need to fulfil cosmetovigilance obligations. This includes brand owners, manufacturers, or importers who act as the Responsible Person (RP) for cosmetics under Regulation (EC) No. 1223/2009 (in the EU/EEA) or the UK Cosmetics Regulations. Every cosmetic product placed on the Great Britain market must have a designated UK Responsible Person (UK RP). If you are an RP managing a portfolio of skincare, haircare, makeup, fragrance, or personal care products, our service ensures you have a compliant system to monitor product safety and report any issues to authorities. We support both large multinational cosmetics companies that require professional oversight of their cosmetovigilance programmes and small or mid-sized brands that may lack in-house safety surveillance expertise.
• Responsible Persons Needing Expert Support: Appointed Responsible Persons (whether in-house or third-party) who require specialised assistance in establishing or operating a cosmetovigilance system. Key duties of the UK RP include CPSR compliance, SCPN notification, PIF maintenance, and SUE reporting. This includes fulfilling obligations such as collecting consumer feedback on Undesirable Effects (UEs), performing causality assessments, preparing Cosmetic Product Safety Reports (CPSRs), maintaining Product Information Files (PIFs), and notifying Serious Undesirable Effects (SUEs) to the authorities. We help RPs implement efficient procedures to capture and evaluate all adverse effects, handle communications with distributors and authorities, and stay inspection-ready. This is particularly valuable for RPs managing multiple brands or having to comply with dual EU and UK requirements post-Brexit. Since 1 January 2021, an EU-based Responsible Person is no longer sufficient for the UK market  a UK-based RP established in Great Britain is required.
  • Companies with Borderline or High-Risk Cosmetic Products: Businesses dealing in borderline cosmetic products (e.g. a cosmetic with borderline medicinal claims or a skin-care product containing active ingredients at high concentrations) who must navigate carefully between cosmetics and other regulatory regimes. Such companies benefit from a strong cosmetovigilance system to detect any safety signals early. Failure to comply with reporting obligations can lead to regulatory enforcement actions, including product withdrawal from the EU market. Our service helps you monitor product safety vigilantly and initiate risk management actions before issues escalate. We also interface with pharmacovigilance or medical device vigilance systems if your product portfolio overlaps, ensuring that any adverse incident is routed to the proper monitoring system.

  (Note: While we provide comprehensive support and can act on your behalf in cosmetovigilance activities, the legal responsibility for cosmetics safety and compliance remains with the designated Responsible Person (or other obligated company) under cosmetics law. We work closely with the RP to fulfil these obligations, but do not assume the statutory role of the RP).

Meeting EU & UK Cosmetovigilance Obligations: The EU Cosmetics Regulation (EC) No. 1223/2009 introduced unified cosmetovigilance requirements, fully implemented when it replaced the previous Cosmetics Directive in July 2013. Companies face the challenge of implementing these rules in practice: establishing processes to collect reports of Undesirable Effects (UEs) from consumers and professionals, performing causality assessments, and if an effect is serious, notifying authorities. Serious Undesirable Effects must be reported within 20 calendar days from the date any employee of the company or the Competent Authority becomes aware of the event, regardless of their role or function. In the UK, the Office for Product Safety and Standards (OPSS) expects equivalent rigour: since 2021, Great Britain follows a domestic regime mirroring EU rules. All SUE forms in the UK should be submittedFor serious undesirable effects reported to District Councils by health professionals or end users in Northern Ireland, Form C must be submitted to OPSS. Navigating the dual EU/UK frameworks can be complex  we help streamline compliance across jurisdictions.

Capturing and Managing Adverse Events Effectively: Cosmetics are generally very safe, and adverse reactions are relatively rare. This can lead companies to underinvest in cosmetovigilance systems or to assume that infrequent complaints do not warrant formal processes. In reality, regulators require robust mechanisms to capture all adverse events and to investigate their causes. An Undesirable Effect (UE) is any adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product. We address this challenge by setting up easy-to-use reporting channels, training your teams to recognise and escalate any potential UE, and feeding this data into a structured evaluation process. Timely internal escalation procedures are essential to meeting the 20-day regulatory reporting deadline for Serious Undesirable Effects.

Ensuring Comprehensive Product Documentation & Risk Assessment: Cosmetic companies must maintain a detailed Product Information File (PIF) for each product, including a Cosmetic Product Safety Report (CPSR) and records of any Serious Undesirable Effects and corrective measures taken. The UK RP must provide the Product Information File within 96 hours of authority request. A common challenge is keeping these documents up-to-date in light of new information. Adverse event data becomes part of the CPSR and must be made available to the public upon request. Depending on the findings, corrective actions may include updating usage instructions, modifying labelling or warnings, reformulating the product, or initiating a recall. Any corrective action must be reported to the original Competent Authority, which then informs other Member States as part of coordinated market surveillance. We assist in updating CPSRs and PIFs with post-market data and ensure that any safety-related changes are documented and implemented compliantly.

Borderline Product and Compliance Issues: Some products marketed as cosmetics may drift into borderline territory (e.g. a cream with an implied therapeutic effect or a very high content of an active ingredient). Misclassification can lead to enforcement actions if regulators deem the product should have been regulated as a medicine or biocide. We provide regulatory guidance to identify such issues early and implement controls (like formula review and claim substantiation) to keep your products safely within the cosmetics regulatory domain. For technically compliant cosmetic products that nonetheless raise safety concerns, we assist in the “safeguarding” notifications required in the UK, whereby you must consult OPSS and potentially take action even if all regulatory limits were met.

Regulators in both the EU and UK expect that cosmetic companies have a proactive post-market surveillance system for product safety:

• A Designated Responsible Person with a Safety System: Every cosmetic sold in the EU or UK must have a Responsible Person (RP) established in the respective market who ensures compliance and safety monitoring. The UK RP can be the manufacturer, brand owner/importer, or a designated third party, and must be established in Great Britain with a physical address (not a PO Box). Authorities expect the RP to have the requisite scientific and regulatory expertise to carry out safety obligations  companies should ensure that obligations are met through a qualified Responsible Person with scientific and regulatory expertise. The RP must maintain the Product Information File (PIF) for each product. In the UK, the RP must provide the PIF within 96 hours of authority request and must keep the CPSR for 10 years after the last batch of the product is placed on the market.
• Active Collection and Assessment of Undesirable Effects: Competent authorities expect companies not only to react to reported problems but also to actively collect and evaluate Undesirable Effects (UEs) as part of ongoing cosmetovigilance. A causality assessment is a central element of cosmetic adverse event reporting  this process evaluates whether a reported event is likely attributable to the cosmetic product used by the consumer. While Competent Authorities may conduct causality assessments themselves, Responsible Persons and distributors are expected to support this process by providing complete and timely information. If a distributor submits the initial report, they must promptly inform the Responsible Person so the assessment can be completed without delay. Even non-serious undesirable effects should be logged internally and monitored in case they reveal trends that might signal an emerging risk.
• Prompt Reporting of Serious Undesirable Effects: Both EU and UK regulators insist on prompt reporting of serious adverse reactions linked to cosmetics. Serious Undesirable Effects must be reported within 20 calendar days from the date any employee of the company or the Competent Authority becomes aware of the event, regardless of their role or function. To ensure consistency across Member States, the EU uses standardised reporting forms: SUE Form A is submitted by the Responsible Person or distributor to notify the Competent Authority; SUE Form B is completed by the Competent Authority to summarise the case when sharing it with other authorities and the Responsible Person; and SUE Form C is used when Competent Authorities transmit reports received from health professionals or end users. In the UK, the Responsible Person must notify OPSS by submitting the SUE report via email. It is important to note that a SUE notification does not necessarily mean that a product is unsafe or noncompliant with the regulations — an undesirable effect from a cosmetic product can arise as a result of an individual allergy or sensitivity. Nonetheless, penalties for non-compliance with cosmetics obligations in the UK include unlimited fines and up to 3 months imprisonment.
• Continuous Risk Management and Product Safety Reviews: Cosmetic companies are expected to integrate cosmetovigilance findings back into their product safety management. That means regularly reviewing whether reported adverse effects (even non-serious ones) warrant changes to the product or its usage instructions. Adverse event data becomes part of the CPSR and must be made available to the public upon request. Corrective actions may include updating usage instructions, modifying labelling or warnings, reformulating the product, or initiating a recall. If a product that is otherwise compliant is discovered to pose a serious risk to health, regulators expect the RP to take action. In the UK, if you identify a cosmetic product which is technically compliant with the legislation but you consider could still pose a serious risk to human health and are intending to take action, you must consult OPSS before taking action  setting out information about the identity of the cosmetic product, a description of the product risk including a summary of any test results or analysis, the nature and duration of any measures proposed (e.g. recall), and information on supply chains and distribution of the product.
• Northern Ireland Considerations: Northern Ireland operates under the Windsor Framework and continues to follow EU cosmetic regulations. Products sold in Northern Ireland require an EU-based Responsible Person and notification in the EU CPNP, not the UK’s SCPN. If you sell in both GB and NI, you need both a UK RP and an EU RP. For serious undesirable effects reported to District Councils by health professionals or end users in Northern Ireland, Form C must be submitted to OPSS.

We deliver a structured, end-to-end service that ensures your cosmetic products remain in compliance with safety monitoring regulations and that you are prepared for any scrutiny by regulators. Our approach spans five key areas:

We help you navigate the cosmetics regulatory landscape in the EU and UK, establishing a solid foundation for compliance:

• Compliance with EU Regulation 1223/2009 & UK Cosmetics Regulations: We ensure your cosmetovigilance system meets the requirements of the EU Cosmetics Regulation (EC) No. 1223/2009 — which replaced the previous Cosmetics Directive from July 2013and the UK’s equivalent retained legislation. This includes clarifying the roles and responsibilities of the Responsible Person (RP) and distributors in each jurisdiction. Post-Brexit, an EU-based RP is no longer valid for products in Great Britain  a UK RP established in GB is required since 1 January 2021. The UK RP and EU RP can be the same company only if they have establishments in both jurisdictions. We ensure that both your EU and UK RPs (if you need both) are aligned on safety surveillance practices so that adverse effects reported in any market are captured and assessed consistently. Companies should stay current with EU guidance and use the harmonised reporting forms for consistency and compliance.
• Scope of Products and Borderline Categories: We clarify which of your products are considered cosmetics and thus fall under cosmetovigilance and distinguish them from any products that might be regulated as medicines or medical devices. If you have a product that rides the border, we assist in borderline classification and ensure that you have appropriate vigilance measures in place. Our service covers all categories of cosmetic products.
• Integration with Overall Safety Compliance: Cosmetovigilance does not exist in isolation — it is part of your overall product safety and compliance programme. We ensure that insights from cosmetovigilance feed into your ongoing obligations like periodic safety reviews of product formulations, updates to the PIF, and any required safeguard clause notifications or product withdrawals.

A core part of our cosmetovigilance service is managing Serious Undesirable Effects (SUEs) and ensuring regulatory compliance:

• Rapid Assessment and Notification: When a potential Serious Undesirable Effect is reported  for example, a consumer is hospitalised with a suspected reaction to a cosmetic our first step is to verify the case details and gather all necessary information. Serious Undesirable Effects must be reported within 20 calendar days from the date any employee of the company or the Competent Authority becomes aware of the event. We have procedures in place to ensure draft reports are prepared and reviewed within days, allowing ample time for internal approval and submission well before the deadline. Timely internal escalation procedures are essential to meeting this requirement.
• Preparing SUE Reports (EU & UK): We handle the entire SUE reporting process. In the EU, we complete the required SUE Form A on your behalf and submit it to the Competent Authority in the Member State where the SUE occurred. We ensure all required details are included according to the European Commission’s SUE Reporting Guidelines. In the UK, we use the OPSS SUE Notification Form to alert OPSS all SUE forms should be submitted to: seriousundesirableeffects@businessandtrade.gov.uk. For serious undesirable effects reported in Northern Ireland, Form C must be submitted to OPSS. We also guide your team in communicating with any involved distributors — the Regulation places an obligation on distributors to notify serious undesirable effects occurring in Europe to the local competent authority, and if a distributor submits the initial report, they must promptly inform the Responsible Person.
• Liaising with Regulators and Follow-Up: After an SUE is reported, regulators may have follow-up questions or require further investigation. We act as your representative in these communications, providing any additional information requested. This harmonised approach supports effective information sharing and coordinated market surveillance across the EU. In the EU, once a Member State’s Competent Authority receives a SUE report, it prepares a SUE Form B to share with other EU authorities and the Responsible Person. We ensure transparency and cooperation throughout these processes, reinforcing trust with regulators.
• Corrective Actions & Preventive Measures: When a SUE or cluster of serious complaints indicates a safety risk, we help you take appropriate risk mitigation actions. Depending on the findings, corrective actions may include updating usage instructions, modifying labelling or warnings, reformulating the product, or initiating a recall. Any corrective action must be reported to the original Competent Authority, which then informs other Member States as part of coordinated market surveillance. In the UK, if you plan to withdraw a technically compliant product due to safety concerns, we assist in the required safeguarding notification to OPSS prior to taking action — you must consult OPSS before taking action and set out information about the identity of the product, a description of the risk including a summary of any test results, the nature and duration of proposed measures, and information on supply chains and distribution.

We embed cosmetovigilance within your broader safety and quality infrastructure, ensuring no information silos and robust oversight:

• Linking Customer Feedback and Medical Support to Cosmetovigilance: Often, the first sign of an undesirable effect comes through customer care or medical information channels. We train and set protocols for your customer service and medical inquiry teams to recognise and capture such information. All reports of potential health-related issues with a cosmetic are funnelled into the cosmetovigilance system. We provide standard operating procedures for this, ensuring the consumer or professional is interviewed thoroughly about the incident (collecting details like product used, batch, circumstances, medical treatment needed) so that the subsequent safety evaluation is well-informed. This integration ensures no adverse feedback is overlooked.
• Quality Control and Safety Surveillance: Cosmetic product issues can sometimes stem from quality defects — for example, microbial contamination, packaging failures leading to formula spoilage, or mislabelling of ingredients. Our cosmetovigilance service works closely with your Quality Assurance (QA) unit. If a pattern of adverse effects suggests a quality issue, we alert your QA team immediately to investigate and initiate any necessary product testing. Likewise, if your QA team identifies a potential safety-related non-compliance, we feed that into the cosmetovigilance process to evaluate potential consumer impact and determine if it constitutes an undesirable effect or serious risk requiring regulatory notification.
• Borderline Product Escalation: If our cosmetovigilance monitoring uncovers that a so-called cosmetic is consistently causing medically significant harm, we help you consider whether the product’s regulatory status is correct. Our cross-functional expertise (with deep knowledge of pharmacovigilance for drugs and device vigilance for borderline device-cosmetics) allows us to approach these scenarios effectively and ensure you remain compliant in whichever regulatory sphere your product belongs.
• Governance and Record-Keeping: We help set up a governance framework for cosmetovigilance in your organisation, including periodic safety review meetings where trends in undesirable effects are reviewed by key stakeholders (e.g. the RP, toxicologists, product development, quality managers). Maintaining detailed, well-organised records, including causality assessments, outcomes, and corrective measures, is essential. Internal procedures should be reviewed regularly to reflect evolving EU guidance and enforcement expectations. We ensure your Product Information Files are kept up-to-date with all cosmetovigilance data. In the UK, the RP must provide the PIF within 96 hours of authority request.

Drawing on extensive experience, we help you avoid (and, if needed, respond to) common pitfalls in cosmetovigilance compliance:

• Lack of a Formal Cosmetovigilance System: Some companies assume that because cosmetics do not require pre-approval, they also do not need formal post-market surveillance. This is a mistake. Regulators can and do audit cosmetovigilance practices. The task of cosmetovigilance falls to the Responsible Person to continuously monitor and record undesirable effects and regularly re-assess the risk associated with them. We develop a tailored Cosmetovigilance SOP for your organisation, train your team, and simulate mock inspections so you are well prepared to demonstrate compliance.
• Missed or Late SUE Reporting: Failure to report Serious Undesirable Effects within 20 days is a serious violation of both EU and UK requirements. Failure to comply with reporting obligations can lead to regulatory enforcement actions, including product withdrawal from the EU market. In our experience, delays often happen because frontline employees do not recognise that a consumer complaint qualifies as a serious health effect, or because communication gaps between distributors and the Responsible Person cause bottlenecks. To prevent this, we establish clear internal reporting timelines to ensure the clock never runs out.
• Incomplete Product Information File (PIF): The Product Information File is the key evidence dossier for each cosmetic. Adverse event data becomes part of the CPSR and must be made available to the public upon request. Regulators may inspect PIFs during market surveillance or in response to safety concerns. A common pitfall is failing to update the PIF after launch for example, not adding a record when a serious adverse event occurs, or not reflecting a formula change in the safety assessment. We keep your PIFs up-to-date and audit-ready. In the UK, a valid CPSR from a qualified assessor must be in place, and the CPSR must be kept for 10 years after the last batch of the product is placed on the market.
• Inadequate Coordination with Distributors and Authorities: Cosmetic companies often rely on importers and distributors in various countries, which can complicate cosmetovigilance. The Regulation places an obligation on distributors to notify serious undesirable effects occurring in Europe to the local competent authority. A known challenge is when a distributor fails to inform the RP or the authority about a serious incident  this not only violates regulations but also undermines consumer safety. If a distributor submits the initial report, they must promptly inform the Responsible Person so the assessment can be completed without delay. We facilitate clear agreements and training for your distributors about their duties.
• Borderline Product Mismanagement: Some companies have faced issues where a cosmetic product caused unanticipated health effects that prompted authorities to question its safety or classification. We help you avoid this by ensuring such signals are caught early through vigilant monitoring.

We provide cosmetovigilance services in both the European Union and United Kingdom, recognising the largely harmonised requirements but also important differences post-Brexit:

• European Union & EEA: We ensure compliance with the EU Cosmetics Regulation (EC) No 1223/2009, which applies across all EU Member States (and EEA countries). When a Serious Undesirable Effect occurs, we liaise with the Competent Authority of the country where it happened, using the harmonised SUE reporting form process. SUE Form A is submitted by the Responsible Person or distributor to notify the Competent Authority, SUE Form B is completed by the Competent Authority to summarise the case when sharing it with other authorities, and SUE Form C is used when Competent Authorities transmit reports received from health professionals or end users. This harmonised approach supports effective information sharing and coordinated market surveillance across the EU. Our service covers all EU/EEA markets and coordinates multi-country surveillance.
• United Kingdom: We guide you through the nuances of the UK’s cosmetovigilance regime after Brexit:
  • Great Britain (England, Scotland, Wales): Since 1 January 2021, an EU-based Responsible Person is no longer sufficient for the UK market. A UK-based RP must be established in Great Britain with a physical address (not PO Box). UK RP key duties include CPSR compliance, SCPN notification, PIF maintenance, and SUE reporting. UK RP is separate from EU RP — you need both for dual-market sales. Penalties include unlimited fines and up to 3 months imprisonment. Any SUE reports should be submitted to OPSS at: seriousundesirableeffects@businessandtrade.gov.uk. We also assist with UK-specific safeguarding notifications: if you identify a cosmetic product which is technically compliant but could still pose a serious risk, you must consult OPSS before taking action.
  • Northern Ireland: Under the Windsor Framework, Northern Ireland continues to follow EU cosmetic regulations. Products sold in Northern Ireland require an EU-based Responsible Person and notification in the EU CPNP, not SCPN. If you sell in both GB and NI, you need both a UK RP and an EU RP. For serious undesirable effects reported in NI, Form C must be submitted to OPSS.

• International Context: While our primary focus is EU and UK, we apply globally recognised best practices in cosmetovigilance. A strong cosmetovigilance system according to EU/UK standards often exceeds the requirements in other regions, giving you a head start in global compliance.

Managing cosmetovigilance effectively requires adherence to certain critical timelines and proactive monitoring schedules. Here are typical timelines associated with key cosmetovigilance activities:

Note: The 20-day SUE reporting deadline is a maximum; best practice is to report as soon as possible, as delays can increase regulatory scrutiny and consumer risk. Timely internal escalation procedures are essential to meeting this requirement. By maintaining constant vigilance and clear internal communication channels, our goal is to keep actual reporting times well within legal limits.

Based on our experience, we help clients sidestep a number of frequent cosmetovigilance pitfalls:

• “No News is Good News” Syndrome: Some companies assume that the absence of frequent complaints means a product has no issues, and therefore they become complacent. This can lead to inadequate preparation for the one serious incident that might occur. We ensure you have a preventative system in place, collecting even minor feedback. The task of cosmetovigilance falls to the Responsible Person to continuously monitor and record such effects and regularly re-assess the risk associated with them.
• Delayed or Omitted SUE Reporting: Failing to report a serious adverse reaction within the required timeframe (20 calendar days post-awareness in both EU and UK) can lead to serious regulatory consequences. Failure to comply with reporting obligations can lead to regulatory enforcement actions, including product withdrawal from the EU market. In the UK, penalties include unlimited fines and up to 3 months imprisonment. We implement clear guidelines: any hint of a serious reaction is immediately brought to our vigilance team’s attention.
• Inadequate Staff Training and Awareness: Cosmetovigilance is relatively new compared to pharmacovigilance, and not all staff may understand that reporting obligations exist for cosmetics. Companies should ensure that all staff involved in cosmetovigilance are trained on Regulation (EC) No. 1223/2009 and the SUE Reporting Guidelines. All UEs and SUEs should be reported without delay, and consumers and health professionals should be educated on how to submit adverse event information. We deliver training sessions to all relevant departments, emphasising that every complaint related to health must be documented and assessed.
• Poor Coordination in Multi-Market Scenarios: If you sell cosmetics across the EU and UK, differences in regulatory regimes can be a source of errors. Since 1 January 2021, an EU-based RP is no longer sufficient for the UK market a separate UK RP is required. Some companies have continued to only notify the EU system, forgetting the separate UK notification, or vice versa. We maintain a clear record of each product’s notification and Responsible Person status in every jurisdiction and verify that any serious adverse event is reported to the correct authorities.
• Incomplete Product Safety Documentation: Regulators can request your Product Information File or ask about the outcome of an investigation into an undesirable effect. A common pitfall is being unable to produce evidence that you investigated an incident or considered its implications. We maintain meticulous records. Maintaining detailed, well-organised records, including causality assessments, outcomes, and corrective measures, is essential. Internal procedures should be reviewed regularly to reflect evolving EU guidance and enforcement expectations.

Both involve post-market safety monitoring, but: Cosmetovigilance is about cosmetic products, which do not undergo pre-market approval but must be safe for use. It focuses on collecting reports of undesirable effects and ensuring that serious cases are reported and managed, as per cosmetics regulations. Pharmacovigilance deals with medicinal products (drugs), which have formal clinical trials and approvals before marketing and require comprehensive adverse event reporting to medicine regulators continuously. Key differences: cosmetic product issues are reported to product safety authorities (like OPSS in the UK or national competent authorities in the EU), whereas drug adverse reactions go to medicine agencies. The thresholds for reporting differ  only serious effects are mandated for cosmetics, with a 20-day timeline. However, both systems share the goal of protecting consumer health.

Successful cosmetovigilance is closely tied to other regulatory and quality functions. We ensure our Cosmetovigilance service integrates seamlessly with your overall compliance strategy and our broader consultancy offerings:

• Quality & GMP for Cosmetics: Our Quality Services team can support good manufacturing practice for cosmetics. Many cosmetovigilance issues originate from manufacturing lapses (like contamination or formulation errors). By helping you implement robust cosmetic GMP and supplier quality management, we reduce the occurrence of quality-related undesirable effects. (See our Quality Services page)
• Pharmacovigilance & Herbal Vigilance: If your product lines include items that blur the line between cosmetics and medicines, our Pharmacovigilance and Herbal Vigilance teams collaborate with our cosmetovigilance experts to handle any grey-area cases. We can determine whether an adverse event on a borderline product should be processed as a cosmetic SUE or as a medicinal adverse reaction and ensure it is reported to the correct authority. (Refer to our Pharmacovigilance Services and Herbal Vigilance pages)
• Medical Information & Consumer Care Services: Our Medical Information Services complement cosmetovigilance by providing a professional front end for customer inquiries. By managing those inquiries, we can directly capture critical details of any adverse effects and feed them into the cosmetovigilance process in real time. (See our Medical Information Services page)
• Regulatory Compliance Consulting: Our expertise in Cosmetics Regulations (EU and UK) extends beyond vigilance. We assist with Responsible Person services, CPSR preparation, Cosmetic Product Notification, and general compliance audits.