Guidance

Guideline I Pharmacovigilance systems, including risk management

Updated 29 May 2024

Applies to England, Scotland and Wales

1. The Marketing Authorisation Holder

The obligations of the Marketing Authorisation Holder (MAH) for pharmacovigilance associated with their veterinary medicinal products are defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 56.

The MAH must ensure that it:

• has a suitable pharmacovigilance system in place for collecting, collating, and evaluating information in relation to suspected adverse events in respect of any veterinary medicinal product for which it holds an authorisation

• has established and maintained one or more pharmacovigilance system master files (PSMF) describing in detail the pharmacovigilance system with respect to its authorised veterinary medicinal products

• has adequate resources available and that training is provided

• takes responsibility and liability for its veterinary medicinal products on the market and continuously evaluates, by appropriate means, the benefit-risk balance of their veterinary medicinal products (VMPs)

• can take appropriate action to address any risk presented, when necessary

The MAH must designate one qualified person responsible for pharmacovigilance (QPPV) for each PSMF it holds, who must be permanently and continuously at the disposal of the MAH. This person is ultimately responsible for all aspects of the pharmacovigilance system.

Usually, the QPPV will be designated to a single pharmacovigilance system and respective PSMF. It is acceptable for the same QPPV to provide services for more than one MAH, for a shared or for separate pharmacovigilance systems (e.g. in the case of subcontractor QPPV) or, if required, to fulfil the role of QPPV for more than one pharmacovigilance system of the same marketing authorisation holder.

The MAH must ensure that the QPPV can fulfil their responsibilities and activities by providing the following:

• appropriate resources, including sufficient trained personnel

• documented procedures

• communication mechanisms, including access to all sources of relevant information

• authority over and access to the PSMF

• an adequate and effective quality management system for the performance of its pharmacovigilance activities

The MAH must also implement mechanisms to keep the QPPV informed of:

• emerging safety concerns

• any other information affecting the evaluation of the benefit-risk balance of their veterinary medicines

This information may be from ongoing or completed clinical trials and other studies the MAH is aware of, including those carried out by organisations with whom the MAH has contractual arrangements, and which may be relevant to the safety of the veterinary medicine.

The MAH must ensure that the QPPV has the authority to:

• implement changes to the MAHs pharmacovigilance system to promote, maintain, and improve compliance

• provide input into the preparation of regulatory action in response to emerging safety concerns, for example, variations, urgent safety restrictions, and, if necessary, communication to the general public

The MAH should assess risks with potential impact on the pharmacovigilance system and plan for business contingency, including back-up procedures to cover, for example, non-availability of personnel, adverse event database failure, or failure of other hardware or software with impact on electronic reporting and data analysis.

If an MAH acquires a Marketing Authorisation (MA)for a veterinary medicine from another MAH, it should be ensured that the previous MAH provides all available pharmacovigilance information relating to the medicine, including any available sales data. The transfer of pharmacovigilance activities and data should be outlined in an appropriate pharmacovigilance agreement.

If someone other than the MAH becomes responsible for the distribution of a veterinary medicine, the MAH must inform the VMD by means of a suitable variation. Suitable pharmacovigilance contracts must be in place to ensure the MAH is informed of any adverse events reported to the distributor.

2. The Qualified Person Responsible for Pharmacovigilance

The obligations of the Qualified Person for Pharmacovigilance (QPPV) are defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 56B.

The QPPV should be appropriately qualified, with documented experience in all aspects of pharmacovigilance so that they can be responsible for and perform the tasks of the post. If the QPPV is not a veterinarian, they should have access to a person qualified in veterinary medicine to assist with technical aspects of adverse event reports. The assistance should be appropriately documented within the PSMF. MAHs must notify the VMD of changes to the name and contact details of the QPPV, including out-of-office hours details, or back-up procedures to ensure business continuity and continued fulfilment of pharmacovigilance obligations.

The QPPV:

• oversees the establishment and maintenance of a pharmacovigilance system which ensures that information about all adverse events which are reported to any personnel of the MAH, is collected, collated, and made accessible at one or more locations

• oversees the preparation for the VMD of the reports referred to in Part 8 of Schedule 1 of the VMR 2013 (as amended). Detailed guidance for the preparation of these reports is included in:

  • guideline III Adverse event reporting
  • guideline IV Signal management, including benefit-risk reports
  • guideline V Post-marketing surveillance studies

• oversees the conduct of continuous overall pharmacovigilance evaluation during the post-authorisation period

• maintains the PSMF and monitors the pharmacovigilance system to ensure continuous improvement through the use of audits, routine monitoring, and an appropriate corrective and preventative action procedure

• answers fully and promptly any request from the VMD for more information. This information, including volumes of sales or prescriptions of a veterinary medicinal product (VMP), aids the evaluation of the benefits and the risks of a VMP

• provides the VMD with any other information relevant to the evaluation of the benefits and risks of a VMP. This information may come from ongoing or completed post-marketing surveillance studies, or from the actual use of a VMP. It may reveal evidence relating to the validity of the withdrawal period, or lack of efficacy, or an adverse environmental event

• liaises with the VMD in relation to any pharmacovigilance inspection carried out by the VMD

The QPPV should have oversight of the pharmacovigilance system in terms of structure and performance. They should be able to guarantee the pharmacovigilance system components and processes, either directly or through supervision. The oversight should include the functioning of the pharmacovigilance system, including:

• quality control and assurance procedures

• standard operating procedures (SOP)

• database operations

• contractual arrangements

• PSMF preparation and reporting

• adverse event reporting

• signal management and benefit-risk evaluation

• compliance data, for example in relation to the quality, completeness, and timelines for adverse event reporting and submission of benefit-risk reports

• post-marketing surveillance studies

• communication to stakeholders

• deviations and Corrective and Preventive Action (CAPA) plan management

• audit reports

• pharmacovigilance training of personnel

The role of the QPPV involves extensive tasks, depending on the size and nature of the pharmacovigilance system, and the number and type of veterinary medicines for which the MAH holds MAs. The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals, for example, an expert on the safety aspects of certain veterinary medicines. The QPPV must keep system oversight and overview of the safety profiles of all veterinary medicines. Such delegation should be documented in the PSMF. In case of absence of the QPPV, an adequately qualified person must undertake their responsibilities, the back-up arrangements in place should be described in the PSMF.

The MAH should maintain high level organisation charts providing an overview of the pharmacovigilance units and organisations and illustrating the relationships between them. The charts should show the main reporting relationships with management and clearly show the position of the QPPV within the organisation. If the tasks of the QPPV are outsourced to a third party those arrangements should be described in the PSMF and included in a service agreement.

3. Quality Management System Supporting the pharmacovigilance system

The requirements for a quality management system (QMS) supporting the pharmacovigilance system are defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 56 and 56B.

The pharmacovigilance system should be supported by a robust and effective quality management system. A QMS is a set of policies, processes, procedures, and records that helps coordinate and direct an organisation’s activities to meet internal and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

An MAH’s QMS should cover organisational structure of the MAH, responsibilities, established processes supported by written procedures, the management of resources for the pharmacovigilance system including sufficient trained personnel, as well as compliance management and record management.

While there must be compliance with the legal requirements, the implementation of a quality system should be adapted to the respective organisation. The quality management system shall be described in the pharmacovigilance system master file.

3.1 Procedures in place, which are documented in writing

An essential element of any pharmacovigilance system is that there are clear, written procedures in place. The quality management system should include detailed procedures, documented in the PSMF. The following list indicates the topics that should usually be covered by these written procedures:

• maintenance of the PSMF

• the collection and processing of adverse events, including data entry and data management, quality control, coding, classification, review, and reporting. The processes should ensure that reports of different types and from different sources are captured:
  • organised data collection schemes, unsolicited, clinical trials, literature
  • GB and non-GB, veterinarians and other health care professionals, animal owners, sales and marketing personnel, and other MAH personnel, licensing partners, regulatory authorities, others

• the follow-up of reports for missing information and for information on the progress and outcome of the cases

• management of duplicate reports

• reporting adverse events to the VMD

• preparation, processing, quality control, review, and submission of the annual benefit-risk report

• global pharmacovigilance activities applying to all products:
  • signal detection and review
  • continuous monitoring of the benefit-risk balance
  • communication with the VMD and animal health care professionals regarding changes to the benefit-risk balance of products and requests for information

• interaction between safety issues and product defects, specifically product defects that could lead to pharmacovigilance issues

• responses to requests for information from the competent authority

• handling of urgent safety restrictions and safety variations

• meeting commitments to the competent authority in relation to a marketing authorisation

• management and use of databases or other recording systems

• management of contracts and agreements

• audits of the pharmacovigilance system

• pharmacovigilance staff training

• archiving of all relevant documents

Care should be taken to ensure that quality control and review are appropriately addressed in the various processes and reflected in the relevant procedures.

Copies of the global and GB procedures should be available within two working days after receipt by the MAH of a request from the VMD.

A list of written procedures should be available and should comprise the procedural document reference number, title, effective date, and document type (for all SOPs, work instructions, manuals etc.). Procedures belonging to service providers and other third parties should be clearly identified.

3.2 Performance indicators

Key Performance Indicators (KPIs) are important because they provide a value to compare against current performance. An MAH should implement KPIs relating to their pharmacovigilance activities that are achievable and measurable, for collection at defined intervals to demonstrate how effectively the MAH is achieving its key objectives.

It is recommended to re-evaluate KPIs at specific periods to determine whether it’s necessary to make changes to the KPIs so they are up to date, achievable, relevant, and in line with the MAH’s objectives.

A list of KPIs, including the reason they were chosen, if applicable, and a description of how to use them should be included in Annex IV of the PSMF.

3.3 Audits

Pharmacovigilance audits should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the pharmacovigilance system. Audit evidence consists of records, statements, or other information, which are relevant to the audit criteria and verifiable.

MAHs should use a risk-based approach to develop an audit programme covering:

• all pharmacovigilance processes and tasks

• the quality system for pharmacovigilance activities

• interactions with other departments, as appropriate

• pharmacovigilance activities conducted by affiliate organisations or activities delegated to another organisation (e.g. regional reporting centres, pharmacovigilance service providers, and third-party distributors)

The risk approach should also account for changes that have occurred since the previous audit, the importance of the processes being audited, and the results of previous audits. The QPPV may be an important source of information relevant to the risk assessment.

It is recommended that audits are conducted by individuals who have no direct involvement in, or responsibility for, the area being audited. The findings of the auditors should be documented in an audit report and should be communicated to relevant personnel, including the auditee and those responsible for the pharmacovigilance system, in a timely manner. Based on the audit findings, the marketing authorisation holder shall ensure that an appropriate plan detailing corrective and preventative actions is prepared and implemented.

The MAH shall place a note concerning critical and major audit findings of any audit relating to the pharmacovigilance system in the PSMF. Once the corrective and preventive actions have been fully implemented, the note may be removed.

The MAH should ensure that a list of all scheduled and completed audits is kept in Annex IV to the PSMF. The dates and results of audits and follow-up audits should be documented.

3.4 Corrective and Preventive Action Plan

MAHs should have processes for managing Corrective and Preventive Action (CAPA) plans implemented in response to any deviations detected in daily operational work, during audits conducted by the MAH, or during a pharmacovigilance inspection.

CAPA plans should be documented in writing and should include the following:

• a root cause analysis

• clear corrective and preventive actions

• a timeline for completion of the actions

• requirements for communication to relevant stakeholders, as appropriate.

If major changes to the pharmacovigilance system are required as part of a CAPA plan it is recommended that a change management process is followed to ensure all relevant stakeholders are consulted.

The MAH should periodically follow up on of the actions implemented as part of a CAPA to ensure their effectiveness.

Documentation relating to CAPA should be retained by the MAH for an appropriate period of time in line with their internal procedures.

3.5 Pharmacovigilance Training

Staff should be appropriately trained for performing pharmacovigilance related activities, taking into account their role within the company. This includes not only staff within the pharmacovigilance units but also staff who may receive or process safety reports, such as sales personnel, technical veterinarians, regulatory affairs, quality assurance, or clinical trial staff. Additionally, all members of an MAH should receive information about what to do if they become aware of a safety concern.

The QPPV should maintain oversight of PV training conducted and required using documented training plans and records. It is expected that personnel will receive training relevant to their role on entering the company and at defined timepoints to ensure continuous development. It is recommended that a system is implemented to monitor the training outcome and ensure the understanding of personnel. Information on training plans and records for pharmacovigilance activities and a reference to their location should be kept in Annex IV to the pharmacovigilance system master file.

3.6 Document management system

The MAH should have a document management system for the storage, management, and control of all documents relating to pharmacovigilance activities. The document management system should be described in Section D of the PSMF.

The document management system should include a database for the compilation of adverse event reports, a description of which should be included in the PSMF. The VMD is flexible as to whether an MAH has an electronic database, depending on the number of reports the MAH receives. However, we would prefer all MAHs to have some form of electronic storage for pharmacovigilance data, for example spreadsheets.

Systems should be in place to ensure the security, integrity, and confidentiality of adverse event data and to ensure that pharmacovigilance data and records are protected from destruction during the applicable record retention period. The length of time for which pharmacovigilance reports are archived should be documented. The VMD would expect this to be at least for the life of the product plus some time to allow for expiry of the product.

Electronic databases used as part of pharmacovigilance activities should be designed and maintained to suit their intended purpose. These systems should be subject to appropriate checks, qualification, and/or validation activities to prove their suitability. Evidence of the validation status of the systems used should be available upon request.

MAHs may use a third party database, with appropriate functionality, as their electronic database for recording adverse events. In that case the VMD would expect this database to be supported by a local record of adverse events maintained by the MAH, for example through the use of a spreadsheet, unless otherwise justified.

3.7 QMS requirements for pharmacovigilance tasks contracted by the MAH

An MAH may transfer pharmacovigilance tasks and functions, including the role of the QPPV, to another person or organisation. The MAH remains responsible for the quality and integrity of all pharmacovigilance tasks carried out. The MAH must have detailed, up-to-date, and clearly documented contractual arrangements with the other persons or organisations involved. They must provide information on such arrangements to the VMD on request. The third party may be subject to inspection depending on the tasks and responsibilities delegated to them.

Pharmacovigilance agreements should be prepared with the aim of enabling compliance with the legal requirements by each party and should contain sufficient detail to ensure that the requirements are met. It is the responsibility of the MAH to decide what provisions need to be included in these agreements, particularly considering the content required in agreements may vary depending on the parties involved. Some provisions which the MAH may wish to consider in agreements are outlined below, however, this list is not intended to be exhaustive, and the MAH should use their judgement when deciding what information should be included in agreements:

• agreed definitions

• the roles and responsibilities of each party

• the types of safety information which should be collected and exchanged (e.g. suspected adverse events, lack of efficacy reports, product quality complaints etc.)

• timeframes for the exchange of safety information between parties and case confirmation and/or reconciliation provisions

• contact details of relevant individuals within each party

• how the transfer of outstanding safety information to the MAH will be handled should the agreement be terminated

• mechanisms for oversight of the third-party by the MAH (e.g. in process compliance measures and the right of the MAH to audit the third-party)

• provisions stating that the third party may not subcontract any task assigned to it by the MAH without the MAH’s written consent

MAHs who co-market a VMP must have arrangements that include measures to avoid the duplicate submission of adverse events to the VMD.

Where pharmacovigilance tasks have been contracted/subcontracted out by the MAH to a third party, those arrangements shall be set out in detail in the PSMF.

4. The pharmacovigilance system

All MAHs are required to have an appropriate system of pharmacovigilance in place as outlined in the VMR 2013 (as amended) Schedule 1 Part 8 Paragraph 56 and 56B. The MAH should ensure that the pharmacovigilance system is:

• fit for purpose

• describes the roles and responsibilities of all parties involved in the system

• supported by an appropriate QMS

• contains systems and processes for monitoring the benefit-risk balance of the MAH’s VMPs, and for managing any risks identified in relation to those products

• is monitored to ensure that, if necessary, an appropriate corrective or preventive action plan is prepared and implemented to improve the operation of the system

• is clearly documented in the PSMF

5. Requirements for the PSMF Summary and the PSMF

When applying for an MA, the Applicant should submit a Summary of the PSMF in accordance with paragraph 2(2)(g), in Part 1 of Schedule 1 of the Veterinary Medicines Regulations and, where appropriate, a description of the risk management plan.

The name and contact details of the QPPV should be provided in section 8.3 of the MA application form. Companies might, for example, use a 24-hour telephone number through which the QPPV or their back-up can be reached, diverting it to the appropriate person according to availability.

The MAH must clearly document the pharmacovigilance system in the PSMF and should have the full PSMF available for inspection when required.

5.1 PSMF Summary

The PSMF Summary should be provided in Part 1 of the MA application and should include:

• the pharmacovigilance system master file reference number

• the pharmacovigilance system master file location

• name, contact details, and place of operation of the QPPV

• a signed statement from the marketing authorisation holder and the QPPV that the QPPV has the necessary means to fulfil the tasks and responsibilities required by the applicable GB legislation

• the type of record management system used for adverse events reports including the name of the database, if applicable

Upon a change in any of the information in the summary of the applicant’s PSMF, the relevant variation not requiring assessment must be submitted to the VMD.

5.2 Content of the PSMF

The MAH must maintain, and make available on request of the VMD, a PSMF that describes the global pharmacovigilance system and reflects the global availability of safety information for UK authorised products.

The marketing authorisation holder may, where appropriate, use separate pharmacovigilance systems for different categories of VMP. Each such system shall be described in a separate PSMF. For each VMP, the MAH must not have more than one pharmacovigilance system described in a PSMF.

The PSMF should be an accurate representation of the pharmacovigilance system that has been established and the MAH must assign a unique PSMF reference number to every pharmacovigilance system covering a UK authorised product.

When pharmacovigilance activities are shared between MAHs it is advised that the partners agree on how to maintain the relevant sections within their own PSMF Accessibility of the PSMF to all the applicable MAHs, and its provision to regulatory authorities should be defined in written agreements.

The PSMF should describe the pharmacovigilance system that is in place at the current time. A system should be in place to review and update the PSMF, as appropriate, to ensure up to date and accurate information. The sections in the main part of the PSMF should contain information that is fundamental for the description of the pharmacovigilance system, whereas the corresponding Annexes should include supplementary information for each section that may change frequently. The content should be indexed and follow the structure described.

The main part of the PSMF should be version controlled, any alteration to the content of the PSMF made within the last five years should be recorded in the logbook, indicating:

• the section that was changed

• information regarding the changes that were made

• the date of the change

• the person that was responsible for the change

• where appropriate, the reason for the changes made

Changes to the information in the Annexes do not need to be tracked in the form of a logbook and version control should be adjusted to the type of information. For example, information in the Annexes of the PSMF that is being regularly updated may include outputs from controlled systems (such as electronic document management systems or regulatory databases). The information and superseded versions of such content may be managed outside of the PSMF content itself, provided that the history of changes is maintained and available.

The main part of the PSMF should contain the following sections:

Section A: Information on the PSMF, including:

• PSMF reference number
• PSMF location

Section B: QPPV, assistant veterinary surgeon and back up procedures, including:

• information on the QPPV including name, contact details, and a signed statement from the MAH and the qualified person confirming that the qualified person concerned has the necessary means to fulfil the tasks and responsibilities required by the applicable GB legislation

• documentation regarding arrangements for the assistance of a veterinary surgeon, if applicable, including the contact details

• a description of back-up arrangements that apply in the absence of the QPPV

Section C: Marketing Authorisation Holder information including:

• a detailed description of the organisational structure of the MAH, including a parent company or group of companies associated

• the position of the QPPV within the organisation

Section D: A description of the document management system including: 

• information regarding the database used for recording adverse event reports, for example paper records, spreadsheets, a database developed in-house, or a proprietary database, including the name of the database if applicable. If the database is capable of assisting the compilation of safety reports and performing electronic reporting to the VMD this should be described. The location where the adverse event database is kept, the person or group responsible for the operations and management of the database, and a summary of the assessment of its fitness for purpose should be described.

• information regarding any additional systems and databases used for pharmacovigilance purposes, for example, signal detection, contract management, sales data, document life-cycle management, CAPA management; brief functional descriptions of these should be provided.

Section E: Quality Management System for pharmacovigilance activities, including:

• a description of the processes used for pharmacovigilance activities

• a description of the training management system in place

• a description of the system used for documenting or archiving information

• a description of the system for monitoring the performance of the pharmacovigilance system

• a description of the responsibilities for quality assurance auditing of the pharmacovigilance system including, where appropriate, auditing of subcontractors. The process for risk-based planning should be described and the rationale for the risk-based schedule should be documented.

• a list of audits associated with unresolved critical or major findings

• a description of the CAPA plan management and change management in place

Section F: A description of the contractual arrangements between marketing authorisation holders and third parties concerning pharmacovigilance activities, where applicable

The PSMF shall contain the following Annexes:

Annex I: a logbook containing records of all changes to the main part of the PSMF

• any alteration to the content of the PSMF made within the last five years should be recorded in the logbook, indicating:
  • the section that was changed
  • information regarding the changes that were made
  • the date of the change
  • the person that was responsible for the change,
  • where appropriate, the reason for the changes made

Annex II: additional information regarding the QPPV, assistant veterinary surgeon, and associated back-up arrangements:

• curriculum vitae including information on qualifications and training of the QPPV and, if applicable, the assistant veterinary surgeon

• a description of the tasks and responsibilities of the QPPV

• list of the pharmacovigilance activities that have been delegated by the QPPV to third parties

Annex III: additional information on the marketing authorisation holder:

• a list of all VMPs registered in GB and covered by the PSMF, including the international non-proprietary name (INN) of the active substances, if applicable, and the authorisation number

• a list of reference numbers for other PSMFs held by the same MAH, where applicable

• the name of the local representative for the purpose of receiving reports of suspected adverse events in GB, including their contact details and responsibilities, where applicable

• a list of the sites where pharmacovigilance activities are carried out

Annex IV: further details about the quality management system:

• a list of documents, policies, procedures, and processes used for pharmacovigilance activities which should include the procedure reference number, the title, the effective date, and document type (SOPs, work instructions, manuals etc.). Procedures belonging to service providers and other third parties should be clearly identified.

• a list of all scheduled and completed audits including outstanding critical and major findings

• a list of performance indicators and how to use them, as applicable

• information on training plans and training records

• a list of risk management measures, including Risk Management Plans (RMPs) held by the MAH, safety related changes to the product literature, and the outcome of risk minimisation measures

Annex V: further information on contractual arrangements between marketing authorisation holders and third parties concerning pharmacovigilance activities:

• a list of the activities or services subcontracted by the MAH to third parties to fulfil pharmacovigilance obligations and information on who the activities or services are subcontracted to, including the name and address of any subcontractors, where applicable

• a list of the tasks of the QPPV that have been totally or partially outsourced and the information on who the activities or services are subcontracted to, including the name and address of the subcontractor(s), where applicable

• a list of existing contracts and agreements with third parties, where applicable, including the products and territories concerned

Annex VI: GB specific information

The VMD is prepared to accept the PSMF produced in line with the EU regulations. In this case the PSMF should include an additional annex covering GB specific information, this may include, but is not limited to:

• a signed statement from the MAH and the qualified person confirming that the qualified person concerned has the necessary means to fulfil the tasks and responsibilities required by the applicable GB legislation

• a list of all VMPs marketed in GB, and covered by the PSMF, including the INN of the active substances, if applicable, and the authorisation number

• a list of contracts and agreements with third parties specific to veterinary medicinal products marketed in GB, not already included in Annex V

• a list of completed and scheduled audits, including outstanding critical and major findings, specific to veterinary medicinal products marketed in GB, not already included in Annex IV

• a list of UK specific written procedures covering pharmacovigilance activities, where applicable

• a list of any risk management measures, including RMPs held by the MAH, safety related changes to the product literature, and the outcome of risk minimisation measures specific to a VMP marketed in GB, not already included in Annex IV

• the name of the local representative for the purpose of receiving reports of suspected adverse events in the UK, including their contact details and responsibilities, where applicable

Where appropriate, information may be provided in the form of charts or flow diagrams.

After the system as described in the PSMF has been formally terminated, MAHs should maintain an electronic version of the PSMF for a reasonable length of time.

Upon request, the MAH must provide a copy of the PSMF to the VMD within seven days of receipt of the request.

6. Risk Management Plans

A VMP is authorised on the basis that, at the time of authorisation, the benefit-risk balance is judged positive for the target population, the user, the consumer of food from food producing animals, as well as the environment. However, not all actual or potential risks are identified when an initial MA is granted; it is recognised that safety information  is relatively limited due to many factors including the limited representation of target animals, for example the number of animals, age, breeds etc, used in the pre-clinical and clinical development of the product. Risks of many potentially affected subpopulations remain to be identified. This is particularly true for novel therapies and for products authorised under ‘exceptional circumstances’ to cover an as yet unmet medical need. In these situations, it may be necessary for the MAH to develop an RMP in relation to a specific VMP or group of related VMPs.

GB legislation recognises that the MAH may need to develop an RMP for inclusion in the MA application before an MA can be granted in accordance with paragraph 2(3)(k), Part 1 of Schedule 1 of the VMR. Requests for the provision of an RMP could also be made following the assessment of pharmacovigilance data as described in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 61.

An RMP is defined as a set of targeted pharmacovigilance activities and interventions designed to identify, characterise, prevent, or minimise risks relating to VMPs. The content and requirements of the RMP will be assessed by the VMD and agreed with the MAH prior to implementation, the following list describes elements that may be required as part of the RMP:

• a description of any known and potential risks and any areas lacking data, including a summary of any specific safety concerns relating to the VMP

• a description of any specific activities required that complement routine pharmacovigilance and that address the specific safety issues, for example through the implementation of post-marketing surveillance studies, data collection questionnaires, or specific sampling

• the RMP may also propose and evaluate potential risk minimisation activities for each specific safety issue should the data collected confirm the need for additional actions

Data generated through an RMP should be provided to the VMD within the timeframe specified in the agreed RMP.  This data would be assessed and the need for further actions determined as appropriate. Once actions outlined in the RMP have been successfully completed, the plan would be terminated.