January 2024 update on implementation of Regulation 2019/6 and associated legislation

European Commission update

According to Article 93(2) of Regulation (EU) 2019/6, the European Commission is required to adopt, by means of implementing acts, legal measures on good manufacturing practice (GMP) for veterinary medicinal products and active substances used as starting materials.  To assist in developing the implementing act concerning GMP, the Commission requested the European Medicines Agency (EMA) for its scientific recommendations on the appropriate measures on GMP. The EMA had fulfilled its task and their recommendations have now been published on the Commission’s dedicated webpage

Should you have any comments on the EMA’s recommendations, please send your feedback to sante-veterinary-medicines@ec.europa.eu  by Wednesday 31 January 2024. Please note that the HPRA understands that all comments will be published on the Commission’s webpage in due course.

EU legislation update

While Regulation 2019/6 was applied throughout the European Union on 28 January 2022, there are still a number of legal acts being elaborated. Of most noteworthy for veterinary medicines are the following:

  • Delegated Act on use of veterinary medicines via oral routes other than in medicated feed. Once the European Commission has finalised the draft legislation it will be submitted to the European Parliament and Council for a scrutiny period of 2 months. It will be finalised at latest in 2025.
  • Implementing Act (IA) on the use of abbreviations and pictograms and IA on small package units. Both drafts will be finalised shortly and should be adopted during Q1, 2024.
  • IA on list of antimicrobials not to be used outside the terms of the MA or only in accordance with certain conditions. Discussions are ongoing with MSs with finalisation is expected by the end of 2024.
  • IAs on Good Manufacturing Practice for veterinary medicinal product and another in respect of starting materials used in veterinary medicines will be developed during 2024. EMA scientific advice is expected to be available in January 2024.
  • Regarding the IA on list of substances which are essential for the treatment of equine species and for which the withdrawal period shall be six months. Elaboration is ongoing with finalisation expected in 2024.
  • Regarding the IA for the establishment of a list of substances which may be used in food-producing aquatic species, EMA scientific advice is currently under preparation and is expected to be available in November 2024.

An independent study on the situation regarding the treatment of equines required by Article 158 of Regulation 2019/6 is being undertaken on behalf of the EU Commission currently. The expectation is that a report will be prepared for consideration by the European Parliament and Council by mid-2024.

A call for tender for a study on the use of traditional herbals is expected to be launched in 2024. The report must be finished by January 2027. A ‘Guidance to Applicants’ which replaces the ‘Notice to Applicants’ is being finalised and is expected to be published during Q1, 2024.

EMA update

The EMA published a document outlining general principles of acceptability and procedure in respect of Quick Response (QR) codes in the labelling and package leaflets of veterinary medicinal products. The document applies to all veterinary medicines whether authorised centrally or nationally.

Regarding the Union Product Database (UPD), Marketing Authorisation Holders (MAHs) are reminded that information on the volume of sales in 2023 for each product should be submitted before 29 February 2024. Further information on this topic is available in Chapter 7 of the EMA’s Implementation Guide.

CMDv update

The CMDv has revised its Best Practice Guide for Variations not Requiring Assessment (VNRAs) which is available on the CMDv pages of the HMA website. Following input from each of the Member States, the guidance document was updated to provide advice to applicants on how to avoid VNRA rejections. One example includes the provision of a positive validation report with the VNRA submission documentation.

The Best Practice Guide for Variations Requiring Assessment (VRAs) has also recently been updated. Following a request from CMDv’s Interested Parties, a dedicated section on the “Implementation” of VRAs has been included to provide additional clarity to MAHs. The MAHs are reminded that the possible implementation timeframe of a VRA can always be proposed in the application form.

The CMDv is actively monitoring the submission of variations for the one-off alignment of the product information with version 9.0 of the QRD templates. Up to now there has been a notably low rate of G.I.18 VRA submissions. MAHs are requested to submit VRAs in a prompt and timely manner to ensure product information is updated before the deadline of 27 January 2027.

National update

The HPRA understands that new national legislation underpinning the requirements for electronic prescribing will be introduced early in 2024. Separately, new legislation replacing SI No 36 of 2022 is also expected to be published around the same time.

The HPRA hosted a webinar on changes to the regulatory framework for veterinary medicinal products on 1 November 2023.  During that webinar it was stated that work to address the requirements of Article 107 of Regulation 2019/6 in respect of changes to the labelling of antimicrobial medicines would begin shortly. Since then, the HPRA has engaged with the CMDv to see if a coordinated position can be agreed throughout the Community. A survey of Member States is underway and the HPRA will await the results of that survey before finalising our plans.