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Frequently Asked Questions

Q. What is the policy on electronic reporting of adverse events?

A. All marketing authorisation holders (MAH) are required to submit expedited adverse event reports electronically from 1st October 2010. MAHs should submit electronic reports to the VMD using the EudraVigilance Veterinary (EV VET) network created by the European Medicines Agency (EMA) in partnership with EU regulatory authorities and industry.

This network enables electronic adverse event reports to be transmitted between EU competent authorities and MAHs in a secure manner. The EudraVigilance Gateway is at the centre of the network and reports are automatically routed through the gateway to the chosen recipient. The EV VET central database is part of the network.

MAHs must register with the EMA to use the network. The gateway is supported by the EMA and information on registering and using the gateway can be found on the EudraVigilance website.

Q. Where can information on the electronic reporting standards be found?

A. The electronic reporting format which should be used is defined in the CVMP Guideline on Data Elements required for the Electronic Submission of Adverse Events Reports which can be found on the EudraVigilance website. This site also contains information about the electronic reporting standards, links to several EU guidance documents on electronic reporting, and a link to the Combined VeDDRA List of Clinical Terms which must be used to code reports.

Q. Do small and medium size companies have to use EV VET?

A. Small and medium size companies should use the EVWEB tool to submit reports electronically. MAHs must register with the EMA to use EVWEB and details can be found on the EudraVigilance website. EVWEB enables both the sending and receipt of electronic Adverse Event Reports by MAHs. The VMD can provide training in the use of EVWEB and requests for training should be addressed to the pharmacovigilance team. The VMD does not accept reports transmitted by the MAH Simplified Electronic Reporting Form.

Q. Which adverse events should an MAH report to the VMD?

A. All serious adverse events in animals and all human adverse events which occur in the UK should be reported to the VMD. These reports should be sent to the VMD within 15 calendar days of receipt of the information by the MAH.

The VMD forwards all serious UK reports to the central EV VET database. These cases must not be sent there directly by the MAH.

Q. Which adverse events should be reported directly to the EV VET database?

A. All serious and unexpected adverse events in animals and all human adverse events which occur in third countries should be sent directly to the EV VET database within 15 calendar days of receipt of the information by the MAH. There is no need to send these reports to the VMD as they will be available for analysis in the central database.

Q. Will the VMD accept Periodic Safety Update Reports (PSUR) covering more than one authorised presentation of a product?

A. National legislation requires a PSUR to be submitted for each marketing authorisation. Combined PSURs might be acceptable provided that their format has been discussed and agreed with the VMD before their submission.

Q. Why does the VMD not accept EU harmonised birth dates as published on the Heads of Medicines Agencies website for generic products?

A. The VMD is always willing to harmonise the submission dates of PSURs for individual products, providing that the overall frequency of these reports respects the schedule set out in Article 75(5) of the Directive and that the MAH describes how the transition will be managed to avoid gaps or overlaps in the data.

The VMD is unable to agree to requests from MAHs to move the PSUR schedule for newly authorised generic products directly to the 3 year PSUR interval. The PSUR submission schedule is specified in European legislation and national legal advice supports the view that there is little flexibility as to its interpretation. Irrespective of legal constraints the VMD considers that it is not appropriate for newly authorised products to move immediately to 3 year PSUR intervals for the following reasons:

  • MA application dossiers do not include Safety Assessments to support requests to move directly to the 3 year interval, and there is currently no guidance on the content of Safety Assessments or their evaluation.
  • Harmonisation of PSUR schedules based on active substance ignores the role of excipients in adverse events. Even for well-known excipients experience has shown that new concentrations or combinations can be factors. For 'Informed Consent' applications, the excipients are not always declared when the copycat MAH differs from the parent MAH. In generic products, the sources of active substances may differ from those used in originator products.
  • The rationale for more frequent PSURs in the 4 years after a product is first placed on the market is justified as it allows a more concentrated level of monitoring during the period when unforeseen safety issues are most likely to become apparent. Implementation of the 'sunset clause' is a further consideration.
  • PSURs are the only source of incidence data. The UK has agreed with industry to use reaction incidence data in response to Freedom of Information questions. Signal detection in the veterinary field has to develop significantly before it can be relied on to yield valid results and in any case it will not be a substitute for incidence data.

Q. Will the PSUR schedule change after a mutual recognition or decentralised procedure?

A. After the completion of a mutual recognition procedure (MRP) or decentralised procedure (DCP), the MAH is required to submit PSURs to all the Concerned Member States (CMS) involved in the procedure. The PSUR schedule should be the same for all competent authorities involved in the MRP or DCP. The PSUR submission schedule to be followed in the CMS is the one in place in the Reference Member State (RMS), unless otherwise agreed during the MRP or DCP. When the UK is a CMS, the VMD will follow the PSUR schedule established in the RMS, and, if a UK national MA existed before the MRP, will not require additional data if the last PSUR submitted to the VMD based on the national authorisation date overlaps the first PSUR submitted after completion of the MRP.

Q. What is the frequency of pharmacovigilance inspections?

A. Targeted pharmacovigilance inspections will be carried out on the basis of a risk assessment and these inspections may incur fees. VMD inspection reports following national inspections will not be disclosed to third parties.

Last Updated: 20 December 2012

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