EMA PV environment
The training for the veterinary regulation pharmacovigilance system by the EMA during autumn 2021 and January 2022 was well organised, providing a good practical understanding on the changes in veterinary pharmacovigilance legislation. Also, the implementation of the EMA environments has been successful. However, regardless of the functioning implementation of these new procedures and improvements in functions by the EMA, the systems of marketing authorisation holders and competent authorities still need further development and discussion within the stakeholders.
Registered users can now log into the following EMA environments:
- EVWeb: allows the sending and receiving of safety and acknowledgement messages via the web user interface
- Data Warehouse (EVVet DWH): query tool to access EVVet data in the Data Warehouse (signal detection and data analysis)
- EVWeb test environment: allows the sending and receiving of safety and acknowledgement messages in the test environment
- IRIS: platform to submit signal management and inspection outcomes
The following guidance has been published for the above mentioned environments:
- EVWEB user manual 1.6
- Data warehouse manual v 1.0
New versions of the IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants (europa.eu) in the Guidance and Support section of the IRIS website. It contains a new section on how marketing authorisation holders can submit annual statements and ad-hoc signal management submissions. These procedures are now available on the IRIS website.
Pharmacovigilance System Master File
With the new Regulation, The Detailed Description of Pharmacovigilance System (DDPS) is replaced by the Pharmacovigilance System Master File (PSMF). The content of the PSMF is described in the VGVP module “Pharmacovigilance systems, their quality management systems and pharmacovigilance system master file” (EMA/257136/2021). With this change, more emphasis is put on the PV quality system and documentation. The PSMF is not approved or submitted to the competent authority unless required. However, it should be at all times ready for inspection or available for CA requests within 7 calendar days. Especially the appendices of the PSMF have a lot of information that changes often, and therefore the specificity of information added and maintenance of information should be thoroughly planned within the company. As no inspections have yet been done for systems utilising the new regulation, it remains to be seen whether the PSMFs’ contents meet the competent authorities’ expectations.
Signal management
The significancy of signal management as a procedure has been raised to be the key element in veterinary medicinal products’ benefit/risk evaluation. Periodic Safety Update Reports are no longer required in the EU, but some of the aspects in the previous PSURs are evaluated in relation to signal detection. The process is described in the VGVP module “Signal Management” (EMA/522332/2020). Signal detection for each product is to be done at least once a year as per a risk-based evaluation on the need for it. The schedule for annual signal detection reporting for MPR, DCP and national authorized products to the EMA has not yet been published, but now is the time to prepare the procedures within the company, including standard operation procedure updates and responsibilities for signal management.
Adverse events reporting
All adverse events regardless of their severity must be reported to the Union Safety Database (EVV) within 30 days after receiving the information. However, causality assessment of the event is no longer required. The process is described in the module ”Collection and recording of suspected adverse events for veterinary medicinal products” (EMA/306663/2021). So far, there have been some challenges in the ICSR reporting and downloading the cases from the EVV due to information missing in the UPD and linking of the UPD and the EVV. However, competent authorities have made good progress in entering the data to the UPD.
The availability of accurate product data in the UPD is key in enabling effective signal detection and management via the EVV. Marketing authorisation holders will be able to see the full cases, including the narrative information as per level 2 of the access policy for the products that have been uploaded into the UPD. For other products, industry users will have level 1 access (without case narratives). While the information is not complete in the UPD, level 2 access may not be available for some reports, it may n take up to 2–3 months from the date that all product information is available in UPD to completely resolve the issue.
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