Implementation of the new veterinary regulation (Regulation 2019/6)

Regulation 2019/6, commonly known as the New Veterinary Regulation (NVR), legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union (EU). The legislation came into effect on 28 January 2019, and applies in all EU Member States (MSs) on 28 January 2022. The Regulation followed the adoption of a proposal in 2014 to develop fit-for-purpose veterinary legislation which would no longer be based on the equivalent human medicines authorisation system.

The timeline for development and implementation of the Regulation is outlined here.

The legislation repeals Directive 2001/82/EC and is intended to:

  • harmonise the internal EU market for veterinary medicinal products

  • reduce the administrative burden on companies and regulatory authorities

  • enhance availability of veterinary medicinal products

  • stimulate innovation of new and existing medicines

  • strengthen the EU response to fight antimicrobial resistance.

As part of its implementation, the NVR requires the European Commission to adopt delegated and implementing acts. These acts flesh out the legal requirements for particular aspects of the legislation, and provide for the adaptation of the legislative framework to accommodate technical and societal changes over the longer term.

The reader can track progress on the elaboration of the delegated and implementing acts here. In respect of a number of acts, the Commission has requested the European Medicines Agency (EMA) to provide advice on the content of the legislation needed. The reader can track progress in respect of all such advices that have been submitted to the Commission here. The EMA has provided the following graphic to help explain its role in the implementation of the NVR, and the systems outlined also apply to the HPRA:


New veterinary regulation - role of the EMA

 

One of the key pillars to enable the success of the NVR is the development of an EU IT platform to deliver the following systems:

  • Union Product Database

  • Union Pharmacovigilance Database

  • Union Manufacturing and Wholesale Distribution Database

  • Collection of sales and use data of antimicrobials in animals

The IT database is being developed under the aegis of the EMA. More information on this is available here.

Whilst the NVR is directly applicable in the EU, in respect of certain provisions, there is discretion for a Member State to apply them or not (i.e. they are ‘may’ provisions). Furthermore, some of the provisions of the NVR run contrary to existing national legislation, meaning that the national legislation governing veterinary medicines will need to be updated. This is a task of the Department of Agriculture, Food and Marine (DAFM). The reader can follow progress on this here.

The HPRA is also engaged with the network of medicines agencies in the EU regarding the implementation. Much of the work of this network is being led by a Task Force; for further details, click here.

The HPRA has embarked on a project to implement the changes needed to its business processes, application forms and guidelines for applicants. The goals of this project are to:

  • Ensure organisational readiness by 28 January 2022

  • Modify internal work processes to meet the requirements

  • Communicate external changes to application forms, guidelines and general requirements to stakeholders

  • Assist the EMA in the elaboration of the new IT systems

  • Modify HPRA IT systems to interface with those being developed by the EMA

  • Upload HPRA data on national marketing authorisations for so-called ‘legacy’ products to the EMA IT systems

  • Assist the DAFM in the elaboration of national legislation

  • Communicate developments to interested parties.

Monthly Updates

The HPRA provides regular updates on developments related to the implementation of the NVR. To see all updates, please visit the Monthly Updates page. 

Contact us

Queries related to implementation of the new veterinary regulation can be sent to newvetreg@hpra.ie.