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

Update of note by the European Commission

On 18 February 2021, the EU Commission advised the network of EU medicines agencies that COVID-19 has had some minimal impact on the elaboration of the implementing and delegated acts that are needed to support timely implementation of the new requirements under the new veterinary regulation (NVR).  However, the Commission maintains its ambition and expectation of timely implementation. The Commission reported that, in accordance with Article 156 of Regulation 2019/6, a contractor is engaged to provide it with a report on the feasibility of an ‘eco-monograph’ system for active substances used in veterinary medicinal products. The final study report is expected to be ready by October 2021. No further developments of note were reported by the Commission during February.

Update of note by the European Medicines Agency (EMA)

During February, the European Medicines Agency (EMA) has published:

  • A new draft reflection paper on eligibility criteria for limited markets (EMA/CVMP/235292/2020). The document has been adopted for publication for a 3-month period of public consultation. Regulation (EU) 2019/6 introduces a legal basis for granting marketing authorisations intended for limited markets with specific provisions (Articles 4(29), 23 and 24). The reflection paper, which replaces the current EMA policy for medicines indicated for minor use minor species (MUMS)/limited market, has been developed to define criteria for classification of a product as intended for a limited market (Article 4(29)) and eligible for consideration in accordance with Article 23.

  • A new draft guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets and submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/345237/2020). The document has been adopted for publication for a 3-month period of public consultation. 

  • A new draft 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 (EMA/CVMP/52665/2020). The document has been adopted for a 3-month period of public consultation.

  • A new draft guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/59531/2020). The document has been adopted for a 3-month period of public consultation.

  • The CVMP strategy on antimicrobials for 2021-2025 (EMA/CVMP/179874/2020). The Committee’s activities regarding antimicrobials over the next five years will focus on supporting the effective implementation of those provisions in Regulation (EU) 2019/6 that take forward the EU’s One Health Action Plan against antimicrobial resistance (AMR). Proposed actions address measures embedding the responsible use of antimicrobials in veterinary medicine, the protection of public and animal health from the risk of AMR and support to the development of new antimicrobials and their alternatives. The CVMP strategy on antimicrobials for 2021-2025 will be published on the EMA website.

The EMA also advised that in respect of new applications to be submitted centrally after 28 January 2022, applicants should include information in relation to eligibility under article 42 in their pre-submission request forms. The EMA is currently revising the forms to allow applications for centralised authorisation for any new product from 28 January 2022.

Update of note by the CMDv

Regulation 2019/6 foresees greater involvement of the Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) in pharmacovigilance activities and to this end, a pharmacovigilance subgroup of the CMDv legislation working group has been activated. A Best Practice Guide (BPG) is being drafted by the CMDv, which gives guidance for the re-examination of the RMS final assessment report in the decentralised procedure and in the variation procedure.

Update on national implementation

Discussions with the Department of Agriculture, Food and the Marine (DAFM) on the development of the new complementary national legislation to the NVR is ongoing. Contrary to original HPRA expectations, the future system for classification of borderline products will remain largely as is currently, but there will be some minor changes to the system (e.g. HPRA template letters will be revised). Furthermore, DAFM has informed the HPRA that it intends to establish a registration system for qualifying products used for aquarium fish, caged birds, terrarium animals, small rodents, ferrets and pet rabbits under Article 5(6) of the Regulation. The registration system will be operated by the HPRA. The detail of the registration requirements for the products concerned will be established by the HPRA shortly. Following this, we plan to host a webinar for the stakeholders involved in this area during April.

Internally, within the HPRA work is continuing on the implementation project. Important developments in recent months are as follows:

  • Continued focus on finalisation of requirements and data standards for the transfer of national data on existing veterinary medicines to the Union Product Database,

  • Finalisation of agenda for HPRA webinar directed towards marketing authorisation holders (MAHs) and veterinary manufacturers on veterinary regulatory aspects of the new veterinary regulation that will be held on 31 March 2021. This is an important event that will be of relevance to everyone involved in the manufacture, authorisation and monitoring of veterinary medicines in Ireland. Participation to the webinar is by invitation only; if you would like to receive an invitation, please provide your details and that of your company (i.e. participation is limited to representatives of a veterinary manufacturer or MAH only, save for representatives from the Department of Agriculture, Food and the Marine who are also being invited) and supply your email address to newvetreg@hpra.ie. The webinar link will be sent to participants in advance of the event.

  • It appears that changes to the national supply categories VPO and VPO-1 will be necessary to fulfil Article 34 requirements of Regulation 2019/6. While the HPRA expects that the VPO and VPO-1 supply categories will cease to exist as a separate legal category from 28 January 2022, the restriction for the products concerned to be used only by veterinary surgeons must instead be specified within the Summary of Product Characteristics (SPC) and product literature (as currently done for centrally-authorised medicines).

If you consider that there are knowledge gaps in the information being made available on regulatory matters on the implementation of the NVR that are within the competence of the HPRA, you are requested to email us on newvetreg@hpra.ie and outline them, so that we may consider addressing them in future update reports or other means.