Update on implementation of the new veterinary regulation – January 2023

EMA update

With the completion of the upload of national product data to the EMAs Union Product Database (UPD), the focus of attention has turned to:

  • improving the functionality of the system,
  • improving data quality.

Over 43,000 individual veterinary medicinal products have been uploaded to the UPD and the EMA Steering Group responsible for the implementation of the IT project has now been stood down. In future, the IT improvements needed to enhance functionality and user experience must compete for resources with other EMA IT needs. They will be prioritised based on the business case. However, information displaying product availability status was deployed at the end of January 2023.

A Guideline on the application of Article 34 of Regulation 2019/6 was adopted by the CVMP at their meeting on 17 and 18 January,2023. This guideline outlines the considerations for deciding if a veterinary medicine is subject to veterinary prescription or not, both for initial marketing authorisation applications as well as for variations to change the prescription status of an existing product.

CMDv update

During the latter half of 2022 the functionality of UPD was increased, making technical grouping of Variations Not Requiring Assessment (VNRAs) possible. The CMDv subsequently published an updated version of the Best Practice Guide for VNRAs advising marketing authorisation holders that the CMDv would be approaching technical grouping of variations in a step-wise approach starting with VMPs from the same range of VMPs (for example, IE/V/0123/001-005). In a slight exception to this rule, the CMDv has allowed the possibility to group VNRAs concerning a change in QPPV and PSMF outside the same range, if it is the same NCA that is responsible for the decision needed.

In December 2022 the CMDv adopted a list of veterinary medicines for SPC harmonisation. This list will go forward for endorsement by the Heads of Medicines Agencies (HMA) at their next meeting in February, after which time the list will be published. Also in December 2022 the CMDv published a revised version of the Q&A - List for the submission of variations according to Regulation (EU) 2019/6 with new additional questions and answers.

European Commission update

The Commission has given a mandate to the EMA to develop the scientific advice needed to underpin the development of a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period will be six months. This development will see the eventual replacement of the current list in Regulation 1950/2006. It will take the form of an Implementing Act, which is expected to be finalised in 2024. 

Another scientific advice under development by an expert group on behalf of the EMA relates to the elaboration of measures on Good Manufacturing Practice for veterinary medicines and active substances used as starting materials as detailed in Article 93(2) of Regulation (EU) 2019/6. The advice is expected to be completed in 2023.

The Commission has provided clarification that veterinary medicines fall within the scope of Directive 94/62/EC on Packaging and Packaging Waste and veterinary medicinal products must comply with the applicable provisions concerned.  This means that the requirements in Articles 10 and 11 of Regulation 2019/6 do not exclude labelling elements required under other applicable EU legislation. The Commission has added that Directive 94/62/EC is under review currently by the Council and European Parliament.

HPRA update

The HPRA continues to work to upload remaining legacy product data to the UPD. We understand that approximately 300 nationally authorised veterinary medicines remain to be uploaded, and we wish to acknowledge the efforts by HPRA and EMA personnel to resolve them. Of the products that remain to be uploaded the issues identified include that:

  • an RMS must create a record to enable the CMS upload in Ireland to function,
  • an RMS from another country has created a CMS status for Ireland for a product in error,
  • the MAHs involved have not yet registered with the EMA’s OMS system.

The HPRA is continuing to work with the EMA and the medicines network to resolve these issues as soon as possible. We encourage MAHs to check that their own products have been correctly created in the UPD, and to contact us if they identify any issues. The HPRA is also working to deploy an API to enable automatic corrections to product data that we have previously uploaded to the UPD. It is expected that this work will be completed within the coming month or so. 

The HPRA understands that the Veterinary Medicinal Products, Medicated Feed and Fertiliser Bill which will repeal the Animal Remedies Act, 1993 and update national legislation of veterinary medicines has been prioritised by government for adoption over the coming months.