Practical Application of the New Veterinary Regulation 

Frequently Asked Questions

The questions and answers below are intended to raise awareness amongst industry in Ireland of the practical implications of the New Veterinary Regulation (NVR). With a little over six months to the go-live deadline of 28 January 2022, industry should prepare for the forthcoming changes if they have not already done so.

The HPRA will update this content on the basis of new developments. Furthermore, the HPRA will look to expand the information on the basis of feedback from industry. New questions from industry can be proposed using the following email address: newvetreg@hpra.ie.

General Queries

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As an Irish MAH, is there a checklist of things that I need to do to ensure that I am compliant with Regulation 2019/6 by 28 January 2022? 

No, there is not a readily available checklist. However, the HPRA recommends that each marketing authorisation holder (MAH) looks to the new requirements of Regulation 2019/6 and is familiar in particular with how to submit variation applications and to conduct the new pharmacovigilance monitoring requirements.

Furthermore, the new EMA Union Product Database (UPD) of authorised veterinary medicines is a fundamental new IT building block in the implementation of the Regulation and will underpin many of the new regulatory processes in the future. The UPD has a number of mandatory data fields to enable the uploading of so-called ‘legacy product’ information to this EU database. While the HPRA is responsible for uploading the national data for individual medicines that are authorised in Ireland, each MAH and veterinary manufacturer organisation should ensure that it is registered with the EMA (so-called OMS data). Users must be registered with the EMA Account Management portal (this is a central point to manage access to EMA systems) and have a relevant user role to request changes and additions to organisation data for OMS and other data fields.

For applicants submitting applications after 28 January 2022, note that the format of the Summary of Product Characteristics has changed, and so too has the scope of the centralised procedure. This means that some applications that might have been submitted for HPRA evaluation under Directive 2001/82/EC will instead fall under the scope of the EMA from 28 January 2022.

 

Union Product Database (UPD)

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What do I need to do as a marketing authorisation holder to enrich my product data in the UPD?

MAHs must register with the EMA Account Management portal in order to access and enrich their product data in the UPD. If the information in the database is incorrect, please engage with the UPD in accordance with the UPD Access Policy.  Articles 55(2), 58(6) and 58(12) require the marketing authorisation holder to record in the product database:

  • the dates when its medicines are placed on the market;

  • information on the availability for each veterinary medicinal product in each relevant Member State and;

  • as applicable, the dates of any suspension or revocation of marketing authorisations, as well as;

  • the annual volume of sales for each of its authorised veterinary medicinal products.

For existing veterinary medicinal products that were placed on the market before 28 January 2022, please record the information relating to dates placed on the market and availability by 28 January 2023.

If I am applying for a new application for marketing authorisation, where do I find information on how to engage with the UPD?

The EU Implementation Guide provides stakeholders, including MAHs, with detailed guidance on the submission of information on medicinal products. You should become familiar with these guidance documents.

Will the HPRA register the data on my currently authorised products in the UPD?

Yes. The HPRA will register a core set of information on veterinary medicinal product authorised in Ireland in the UPD. The HPRA expects to upload information in respect of those products for which it is reference member state before 30 October 2021, and then to proceed to upload the remaining data by 28 January 2022.

 

Pharmacovigilance 

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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).

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.

 

Marketing authorisations 

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According to my licenced documents, my marketing authorisation ceases to be valid on the 1 February 2022. Do I need to submit a renewal application or will the HPRA issue them automatically?

In line with current Directive 2001/82/EC requirements, renewal applications should be submitted at least six months before the marketing authorisation (MA) ceases to be valid. As such, although the period of validity of the MA falls after the 28 January 2022, the renewal application should be submitted six months in advance of the expiry date. The renewal application will be processed in line with current Directive 2001/82/EC requirements. The HPRA will provide additional information to stakeholders when it is available, and we will keep you up to date on emerging information on our dedicated NVR webpage on our website. 

Will the HPRA continue to display a list of authorised veterinary medicinal products on its own website?

A decision on this has not yet been taken. The HPRA is considering how best to ensure that updated information is available on authorised veterinary medicines, whether in the UPD or on its own website.  An update will be provided once the decision has been made. 

How and when should I update my product information templates for my currently authorised MAs?

The MAH will have until 29 January 2027 to update their product information texts. Please note that the texts are still under draft by the European Medicines Agency's Working Group on Quality Review of Documents. To update the texts, a one-off variation requiring assessment will be required to align the product information with the latest version of the QRD templates. The timing of submission should ensure that the variation is finalised and implemented before 29 January 2027.

I plan to submit a new DCP application in December 2021. Should my proposal for the labelling be compliant with the current regulation or new regulation requirements (once finalised)?

Marketing authorisation applications validated before 28 January 2022 shall be processed in accordance with Directive 2001/82/EC. Therefore, proposals for the product information should be in line with current requirements (QRD version 8.2). 

 

Variations

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If I am submitting a variation not requiring assessment, how do I do it?

Variations not requiring assessment will be submitted to the Union Product Database (UPD). The process is still under review by the EMA. Information will be provided to stakeholders when it is available, and we will keep you up to date on emerging information using the dedicated NVR webpage on our website. 

If I submit a variation application on or before 28 January 2022, how will it be processed by the HPRA? 

The variation application will be processed in accordance with the requirements of Directive 2001/82/EC.  Applications submitted after 28 January 2022 will be processed in accordance with Regulation 2019/6.