Practical Application of the New Veterinary Regulation 

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.

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.

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.

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).

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.

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.

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. 

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.

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.