If I receive a report of a suspected adverse reaction on 30 January 2022, how should I handle it?
MAHs should continue to record and report suspected adverse reactions in accordance with current guidance until 27 January 2022. However, from 28 January 2022, in accordance with Article 76.2 of the regulation, MAHs will need to upload all suspected adverse event reports reported to them to the Union Pharmacovigilance Database within 30 days of receipt of the reports.
What is happening to periodic safety update reports (PSURs)?
PSURs will no longer be required under the new veterinary regulation. Instead, MAHs will need to carry out a signal management process for their veterinary medicinal products, the outcome of which must be recorded on the European Medicines Agency’s Union Pharmacovigilance Database. This database is currently being developed.
As submission and assessment of PSURs after 28 January 2022 is not foreseen in the regulation, only PSURs submitted to the HPRA prior to 28 January 2022 will be assessed, i.e., those submitted on or after 28 January 2022 will not be assessed.
Consequently, MAHs with a PSUR data lock point (DLP) of 27 November 2021 or earlier will need to submit those PSURs for assessment prior to 28 January 2022. Marketing authorisations with a PSUR DLP falling between 28 November 2021 and 27 January 2022 may also be submitted prior to 28 January 2022 for assessment.
What if the data lock point (DLP) for the next PSUR falls after 28 January 2022, how will we handle reporting non-serious ADR reports?
The HPRA is aware that for a number of marketing authorisations currently on a three-year PSUR submission cycle and for which the DLP for the next PSUR submission falls on or after 28 January 2022, those non-serious adverse event reports that would normally be reported in a PSUR will not be available for review by the HPRA within the context of a PSUR assessment.
However, it is expected that those adverse event reports will be included within the first signal management process to be conducted by marketing authorisation holders in accordance with Article 81 of the Regulation.
Please note that MAHs can currently submit non-serious adverse event reports directly to EudraVigilance Vet data warehouse (not to the National Competent Authority) and are encouraged to do so.
Further information is also available from the CMDv Question & Answer document on transitional arrangements for the entry into application of Regulation (EU) 2019/6 (link here) and which includes recommendations on the transition from PSURs to signal management (see section 2).
What is a Pharmacovigilance System Master File (PSMF) and how does the system work?
In accordance with Article 77.2 of the Regulation, from 28 January 2022, MAHs must have in place a PSMF that describes in detail the pharmacovigilance system for their product(s). This replaces the current Detailed Description of the Pharmacovigilance System (DDPS). However, the PSMF is not included in the marketing authorisation dossier of VMPs but instead only a summary of the PSMF will be required to be included in the application dossier for new marketing authorisations. The HPRA understands that existing products will not require updates to their dossiers to replace the DDPS with a summary of the PSMF. The PSMF is to be located at the site location where the main pharmacovigilance activities of the MAH are performed, or where the QQPV operates (within the EU).
What information do I need to record in the Union Product database in respect of a PSMF and how should I do it?
As previously highlighted by the HPRA, as of 28 January 2022, all MAHs need to have a Pharmacovigilance System Master File (PSMF) in place for all authorised veterinary medicinal products (both new and existing products).
The European Medicines Agency has recently published guidance on use of the Union Product Database.
In that guidance, question number 25 indicates that the PSMF reference number/code and its location shall be included in the Union Product Database (UPD).
As the Q&A recommends that MAHs agree with NCAs how to upload this information, the HPRA wishes to clarify that such information should be recorded on the UPD by way of a variation not requiring assessment (VNRA) and should not be submitted directly to the HPRA. Note that the information to be uploaded to the UPD relates specifically to the reference number/code and location of the PSMF i.e. the PSMF itself does not need to be uploaded to the UPD.
As indicated in the aforementioned Q&A document, it is recommended to postpone submission of a VNRA to upload this information to the UPD until June/July 2022 when the next release of VNRA functionality will go live.
Where can I find guidance on pharmacovigilance signal management?
Guidance on the signal management to be conducted by MAHs in accordance with Article 81 of the Regulation is currently being drafted by the EMA and will be published on their website in due course.