Monthly update on implementation of the New Veterinary Regulation — July 2021

Update of note by the EMA

The CVMP adopted the revised QRD product information template v.9. This document, which has been updated based upon the outcome of the public consultation, reflects the requirements of Regulation (EU) 2019/6 for the summary of product characteristics and packaging. Further information is available on the EMA website.

The CVMP adopted a number of documents related to medicinal products for limited markets following the close of public consultations. The documents are available to view on the EMA website and are as follows:

  • A reflection paper on eligibility criteria for classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 of Regulation (EU) 2019/6 (applications for limited markets);

  • A procedure for companies to request the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4 (29) and for eligibility for authorisation according to Article 23 of Regulation (EU) 2019/6;

  • A guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6;

  • A guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6;

  • A guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets applications submitted under Article 23 of Regulation (EU) 2019/6.

Update of note by the CMDv

The CMDv has prepared a Q&A document in order to assist both MAHs and NCAs in the management of the transition between the requirements of Directive 2001/82/EC and Regulation (EU) 2019/6. Current topics included in the document include renewals, the update of QRD templates and the transition from PSUR to signal management. This document will continue to be updated with new developments.

Following adoption by both CVMP and CMDv in their respective July meetings, version 9 of the English versions of the QRD veterinary templates, have now been published. As a next step, the EMA will finalise the combined label-leaflet QRD template in the fourth quarter of 2021, for use when there is no package leaflet and all information has to appear on the outer packaging.

Update of note by the European Commission

The European Commission continues to focus on the elaboration of the 12 acts relating to the first and second packages of the secondary legislation, which must be adopted by 28 January 2022, together with the two acts on ‘horse passports’ which are linked to the Animal Health law.

Concerning the delegated act relating to the criteria for reserving antimicrobials for use in humans, the matter was considered by the European Parliament sub-group on 13 July. Arising from their concerns, the proposal for a delegated act must now be considered by the Parliament. At a minimum, this action could lead to a delay in the adoption of the act until September. Alternatively, it could mean that the proposal will have to be withdrawn in favour of a more conservative approach to the availability of veterinary antibiotics in the EU. The Federation of Veterinarians of Europe has stated that such an action would risk that half of the antimicrobial medicinal products on the EU market would be lost, meaning that many bacterial diseases in animals could no longer be treated.

Regarding the feasibility of a substance-based monograph system for environmental scrutiny of active substances in veterinary medicinal products under Article 156, the EU Commission has reported that an interim report on the feasibility of such a centralised system has been received from the contractor. A final study report is expected to be ready before the end of September 2021.

Update of note by the HPRA

The HPRA is planning to host an information day for marketing authorisation holders and veterinary manufacturers on 28 October 2021. The purpose of the information day is to provide stakeholders with the opportunity to hear first-hand how the new requirements will affect them and to outline future developments. The HPRA is currently finalising arrangements for the event. Although it is being planned as an in-person all-day event in a Dublin airport hotel venue, some presentations may be given online. Depending on COVID-19 restrictions in place at that time, the event may transition to an online format instead. A separate notice on the event, including details on how to register and a draft programme, will be uploaded to the HPRA events webpage in early September.

The HPRA has published a webpage containing responses to frequently asked questions about the NVR. The content covers the topics of pharmacovigilance, the Union Product Database, marketing authorisations and variations.

A draft guideline for the registration of qualifying medicinal products under Article 5(6) of Regulation 2019/6 is now available on the HPRA website. The guidance is intended for those companies wishing to obtain registration for the marketing of veterinary medicinal products intended for the following animals which are exclusively kept as pets: aquarium or pond animals, ornamental fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits that qualify for registration under Article 5(6) of Regulation 2019/6 in Ireland. It covers the criteria for registration. It provides advice on the administrative aspects of the registration scheme and gives guidance on how the application should be made and the registration maintained. The HPRA cannot accept applications until the necessary national legislation is available in early 2022.

Next report

As the main EU bodies are closed during August, no report will be issued unless some exceptional news must be communicated. The next report is planned for the end of September 2021.