Developments on the implementation of Regulation 2019/6 — regular updates
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. It applied in all EU Member States from 28 January 2022.
In the lead up to the date of application, we shared monthly updates on this webpage to communicate information on key legislative, regulatory, ICT and procedural changes relating to veterinary medicinal products. From February 2022, the updates will be provided on an ‘as needed’ basis, as there are new developments to report.
The updates summarise relevant developments from the European Commission, the European Medicines Agency and the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary. The updates also contain HPRA information about the national implementation of the Regulation.
Please send queries relating to implementation of the new Regulation to email@example.com.
Highlights from each monthly update are outlined below. Please click through to each monthly update for more information.
New national legislation is being developed by the Department of Agriculture, Food and the Marine, to complement the implementation of the NVR nationally. For information on these developments, click here.
July 2022 update
Highlights in the July 2022 update include:
- The EMA has updated video tutorials on using the Union Product Database (UPD).
- The EMA has opened a consultation process for a draft guideline on the application of Article 34, which deals with the prescription status of veterinary medicines.
- The CMDv will publish a list of candidate products for possible SPC harmonisation and will appoint a reference member state for each product.
- The CMDv will soon publish best practice guides on parallel trade and informed consent for MRP, SRP and DCP, in addition to guidance on the processing of generic and hybrid applications through MRP/SRP/DCP.
- The HPRA has uploaded 83% of legacy product data on veterinary medicines to the UPD and is working with the EMA and other national authorities to resolve the issues for the remaining national products.
- The DAFM has published new draft legislation on veterinary medicinal products, medicated feeds and fertilisers and has updated its website FAQs on the implementation of Regulation 2019/6 in Ireland.
May 2022 update
Highlights in the May 2022 update include:
The EMA published the 10th edition of its newsletter, providing an update on the implementation of the new Regulation.
The EMA opened a public consultation for guidance on Article 34. Article 34 sets out criteria for making veterinary medicines subject to a veterinary prescription.
The CMDv is finalising Best Practice Guides on the topics of parallel trade and classification and is revising its guide for variations.
The European Commission has stated that the list of antimicrobials reserved for human use will be discussed at the Standing Committee on 4 July.
The HPRA has uploaded 86% of its legacy product data to the UPD and is working with the EMA to progress the remaining uploads.
The HPRA has published presentation slides from its recent webinar. Videos recordings will be published shortly.
The Department of Agriculture has provided an update to the HPRA on planned national legislation.
March 2022 update
Highlights in the March 2022 update include:
- The EMA reports that 70% of EU products have been uploaded to the Union Product Database. Hotfixes and new version releases for the UPD are scheduled for April 2022.
- The EMA has established a pilot signal management evaluation group.
- The CMDv has released Best Practice Guides for consultation on the topics of parallel trade and classification.
- The European Commission will publish a regulation in May on the interpretation of the management of transitional measures on packaging and labelling of existing products.
- The European Commission is expected to publish the list of antimicrobials reserved for human use in April, but will not complete its work on the list of antimicrobials restricted under the cascade provisions until Q3 2022.
- The HPRA has uploaded over 1,150 nationally-authorised products to the UPD and works continues to upload the remaining products for which Ireland is a CMS.
- The HPRA will host a webinar for industry stakeholders on our first experience of the new veterinary regulation on 19 May 2022.
January 2022 Update
In 2022, updates will be published when required. The January 2022 update was published on 28 January 2022 and the next update is expected to take place by the end of March 2022.
Highlights in the January Update include:
Highlights in the December Update include:
- The EMA published a Q&A to provide information for industry stakeholders on the Union Product Database.
- The CVMP has adopted a Q&A document on the requirements for pre-clinical studies submitted in support of marketing authorisation applications.
- The CMDv published Best Practice Guides for public consultation on the topics of marketing authorisations in exceptional circumstances and for tasks related to pharmacovigilance.
- The European Commission has advised the EMA that the recommendation for the reserved list of antimicrobials to be reserved for human use should be submitted by the end of February.
- The Department of Agriculture, Food and the Marine has published a website section to communicate information relating to legislation coming into effect in 2022.
- The HPRA expects to upload legacy product data to the UPD before 28 January 2022. Companies are reminded that details of their organisation as well as the manufacturer for batch release must be registered in SPOR in order for the HPRA to upload product details to the UPD. If this is currently not the case, you must register with SPOR as a matter of urgency.
- The HPRA will issue another update in January 2022 after which, updates will be issued only when new developments arise.
December Update - New Information
Further to the publication of the “New Veterinary Regulation – December update” on Friday 17th December, the HPRA would like to advise our stakeholders that CMDv have since published final versions of the BPGs for variations not requiring assessment, variations requiring assessment and worksharing variations. These documents can be found on the following CMDv webpage.
Highlights in the November Update include:
- The EMA has published the Guideline of Veterinary Good Vigilance Practice.
- The CMDv has launched a public consultation process on Best Practice Guides covering the topics of validation of applications, changing the reference member state and marketing authorisations for products intended for limited markets.
- The CMDv has added new information to its website on the re-examination procedure after DCP/VRA, in addition to adding a new website section on SPC harmonisation.
- The European Commission published the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans.
- Video recordings and Q&A documents from the recent HPRA information day are now available.
Highlights in the July Update include:
Following the close of public consultation, the EMA’s CVMP adopted a number of documents related to medicinal products for limited markets.
The CMDv has published a Q&A document covering topics such as renewals, QRD templates and the transition from PSUR to signal management.
The European Parliament will consider concerns relating to the delegated act on reserving antimicrobials for human use, which may lead to delays or changes to the act.
On 28 October 2021, the HPRA will host an information day for marketing authorisation holders and veterinary manufacturers.
The HPRA has published a webpage containing responses to frequently asked questions about the NVR. The content covers the topics of pharmacovigilance, the Union Product Database, marketing authorisations and variations.
Please note that the next update is scheduled for publication at the end of September.
Highlights in the May update include:
Highlights in the April update include:
The European Medicines Agency is currently supporting Member States to prepare for the new IT system being introduced as part of the New Veterinary Regulation. Training for industry stakeholders is expected to take place later this year.
The Coordination Group for Mutual Recognition and Decentralised Procedures (Veterinary)
has confirmed the timeline for moving to a new QRD template.
The European Commission has confirmed that it remains on track to adopt the required secondary legislation and ensure the operation of the Union Product Database later this year.
A recording and other material from a recent HPRA webinar for marketing authorisation holders and veterinary manufacturers are now available online.
Highlights in the March Update include:
A revised QRD template, to come into effect in January 2022, has been released by the European Medicines Agency for a seven-week period of public consultation.
The Coordination Group for Mutual Recognition and Decentralised Procedures (Veterinary) is developing a number of best practice guides on variations classification; variations not requiring assessment; variations requiring assessment, unforeseen variation and allocation of procedure number.
The European Commission has provided an update on progress regarding delegated and implementing acts.
A recording of a recent HPRA webinar will be made available on the HPRA website in mid-April. The webinar covers information about how the New Veterinary Regulation affects marketing authorisation holders and veterinary manufacturers.
Highlights in the February Update include:
A European Commission feasibility study for developing an eco-monograph system for active substances used in veterinary medicinal products;
Draft guidelines recently published by the European Medicines Agency and adopted for a period of public consultation;
Activation of a pharmacovigilance subgroup within the Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary;
A new registration system for qualifying products used for aquarium fish, caged birds, terrarium animals, small rodents, ferrets and pet rabbits;
A HPRA webinar for marketing authorisation holders and veterinary manufacturers to be held on 31 March.
Highlights in the January Update include:
The Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary is currently drafting best practice guides for product selection for SPC harmonisation, harmonisation of reference products, and harmonisation of generic and hybrid products.