News Category: Regulatory news
Regulation 2019/6, also known as the new veterinary regulation, comes into effect in the European Union today following a three-year implementation period. The Regulation modernises the existing rules on the authorisation and use of veterinary medicines in the EU. It contains new measures for increasing availability and safety of veterinary medicines and strengthens actions to keep antimicrobials (including antibiotics) working effectively.
The key objectives of the Regulation are to:
-
simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines, for example through streamlined rules for monitoring the safety of medicines;
-
stimulate the development of innovative veterinary medicines, including products for small markets;
-
improve the functioning of the internal market for veterinary medicines;
-
strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals, including reserving certain antimicrobials for the treatment of infections in people.
The Regulation has been complemented by new national legislation (SI No 36 of 2022) that was drafted by the Department of Agriculture, Food and the Marine (DAFM) and published on 27 January 2022.
HPRA role in implementation
The HPRA has been preparing for implementation since the Regulation was adopted in 2018, engaging with industry stakeholders, DAFM, and the network of European medicines agencies, to ensure readiness for today’s go-live date.
The HPRA has coordinated a project to reform its internal processes, procedures and IT infrastructure, in addition to providing guidance and support to stakeholders working towards implementation. As part of an EU-wide project to launch the Union Product Database, the HPRA is working to upload data for nationally authorised medicines as well as for medicines for which the HPRA acted as Reference Member State.
Throughout 2021, the HPRA kept industry stakeholders informed of new developments by holding several webinars and regularly updating its website. The HPRA website resources include:
In addition, relevant pages and guidance documents in the Veterinary website section are being updated to reflect the changes coming into effect from today.
Continued stakeholder engagement
The HPRA will continue to proactively communicate key legislative, regulatory, ICT and procedural changes relating to veterinary medicines. An update linked below communicates developments from the month of January. Going forward, the HPRA will publish updates when required, with the next update expected to take place by the end of March 2022.
Additionally, the HPRA continues to welcome queries from stakeholders working to implement changes. Please contact us by email at newvertreg@hpra.ie.
Update January 2022
An update for January 2022 is now available and provides a summary of relevant updates from the European Commission, the European Medicines Agency, the Coordination Group for Mutual Recognition and Decentralised Procedures (Veterinary), in addition to a HPRA update on the national implementation of the Regulation.