Update on implementation of the new veterinary regulation - March 2022

Published 30 March 2022

Update by the EMA

The Union Product Database went live on 28 January 2022. The initial focus by the EMA has been to ensure the stability of the platform and to facilitate the uploading of legacy product data by Member States (MSs). There have been a number of teething problems associated both with the platform and with the ability of MSs to upload their legacy data. At the time of writing, over 70% of all EU products have been uploaded successfully to the platform. Further hotfixes, as well as new version releases, are planned before the end of April. Once legacy data have been uploaded, the focus will move towards improving data quality.

The EMA has established a pilot signal management evaluation group, whose role is to:

  • Set up and test the new process regarding signal management of adverse reactions to veterinary medicinal products in the European Union,

  • To identify, prioritise and assess safety issues that must be addressed in relation to the monitoring activities,

  • To support/perform targeted signal management activities across the network,

  • To transmit to the Pharmacovigilance Working Party signals detected and proposed regulatory actions,

  • To contribute to the preparation and provision of training for national competent authorities (NCAs) and stakeholders.

The group is a worksharing group composed of delegates from both the EMA and NCAs, including the HPRA, who meet weekly at present.

The ninth issue of the EMA newsletter on implementation of the IT veterinary systems associated with Regulation 2019/6 has been published.  

At the meeting of the Committee for Veterinary Medicinal Products (CVMP) in March, the CVMP adopted a concept paper on the elaboration of guidance for the application of Article 34, relating to the classification of a veterinary medicinal product as requiring a veterinary prescription or not. There will be a one-month period of consultation until 15 April 2022. 

Update by the CMDv

The CMDv continues to finalise a number of guidelines associated with the implementation of Regulation 2019/6 and you can stay up to date by consulting the CMDv resources on Regulation 2019/6. The following recent developments are of note. 

The Best Practice Guide for parallel trade in veterinary medicinal products and the Best Practice Guide for classification of a product or group of products have been released for a period of public consultation, which will end on 28 April 2022.

The guidance document previously referred to as the “Packaging ‘blue box’ requirements” is under revision at CMDv level and stakeholders will be kept informed as to the progress of this document. The previously published CMDv Q&A document which handles the transitional arrangements for the entry into application of Regulation (EU) 2019/6 has recently been revised and offers advice on when it is acceptable to update from version 8.2 to version 9 of the QRD during ongoing new marketing authorisations application procedures.

Furthermore, this revised document includes an Annex which outlines how individual Member States will handle renewals of marketing authorisations after 28 January 2022. At its March meeting, CMDv agreed that a single VNRA under the code C.6 could be applied for legacy data (products already authorised) in order to update the PSMF number and location in the Union Product Database. The Q&A on variations published on the CMDv webpages of the HMA website will be updated to reflect this decision.

Update by the European Commission

The European Commission is expected to publish a regulation in May on the interpretation of the management of transitional measures on packaging and labelling of existing products. The draft legislation is being discussed at the level of the European Parliament and Council of Ministers currently. The regulation will provide for the phasing in of new packaging changes required by Regulation 2019/6 over a five-year period to January 2027. It should be noted that the transition period will apply only to packaging changes and not to other changes required by Regulation 2019/6.

The European Commission has engaged with Member States in relation to the finalisation of the implementing act for the designation of antimicrobials reserved for treatment of certain infections in humans. The implementing act is expected to be finalised in early April. Consideration is also being given to the timelines needed for its implementation in the Community. Work on the development of an implementing act on the list of antimicrobials, which shall not be used in accordance with Articles 112-114 (cascade) or which may be used in accordance with these articles subject to certain conditions (Article 107(6)) has been stalled, and is not expected to be completed until Q3, 2022 at the earliest.

Update by the HPRA

The HPRA had completed the upload of over 1,150 nationally-authorised products to the Union Product Database (UPD) as of the publication date of this article. Work to upload the remaining 800 veterinary medicines for which Ireland is a CMS is ongoing and is expected to be completed over the coming weeks. In the meantime, if you have an urgent request for a product to be uploaded to the UPD, please contact vetinfo@hpra.ie and we will work to accommodate your request.

The HPRA plans to host a webinar on the experience with the new veterinary regulation on the morning of 19 May. Further information on this event will be available on the webinar information page in April. The event will be free of charge to marketing authorisation holders but registration will be essential.