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 newvetreg@hpra.ie.

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.

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: 

  • The EMA has provided training resources and information for industry stakeholders on areas such as the UPD, the OMS and other areas of the new Regulation. 

  • The EMA has advised that the expected UPD functionality will not be available for 2-3 weeks after go-live. More detail is available in the January update, linked above. 

  • The CMDv has released best practice guides for public consultation, has published a Q&A document on variations and will soon publish templates for new marketing authorisation procedures.

  • The European Commission has published a statement on Article 152(2) of the Regulation and is preparing a proposal for a legal act that would allow MAHs to continue to place veterinary medicines complying with the packaging and labelling requirements of Directive 2001/82/EU or Regulation 726/2004 on the market until 29 January 2027.

  • The HPRA has completed the upload of common data for over 600 products for which Ireland was Reference Member State. Work to complete the upload of the national specific data for these products, together with nationally authorised veterinary medicines, is expected to continue over the coming weeks.

  • The DAFM has provided new national legislation (SI No 36 of 2022) and further national legislation is planned by DAFM for enactment during 2022. 

 

2021 Updates 

December Update

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.


November Update 

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.



October Update

Highlights in the October Update include:

  • Recordings from three recent EMA webinars are now available. The EMA has announced a number of upcoming webinars, in addition to an information day scheduled to take place on 30 November.

  • The CVMP adopted a concept paper on scientific guidelines for limited market products not eligible under Article 23 of the NVR.

  • The CMDv has published a number of documents relating to the classification of variations, in addition to a Q&A document on transitional arrangements.

  • The European Commission has published draft criteria for antimicrobials to be reserved for human use.

  • The HPRA will make video recordings of the recent information day available on its website by mid-November.


September Update

Highlights in the September Update include:

  • The EMA launched the Union Product Database on 27 July. The HPRA expects to upload the relevant data by 31 October.

  • The CVMP has published a reflection paper in relation to when an environmental risk assessment can be requested for generic veterinary medicines under the NVR.

  • Joint EMA/CMDv guidance has been published on the classification of variations requiring assessment.

  • The European Parliament rejected a proposal to ban the use of certain antimicrobial medicines in animals. The Parliament will now determine those antimicrobials to be reserved solely for human use. More information is expected before the end of the year.

  • Registration is open for a HPRA virtual information day on 28 October.

July Update 

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. 

June Update

Highlights in the June update include:

  • The EMA has adopted a number of draft guidelines for a two-month period of public consultation. These include guidelines on pharmacovigilance practice, communication and inspections.

  • The CMDv is in discussions with the European Commission on transitional measures that are due to be implemented in preparation for January 2022.

  • The European Commission is continuing its work on the Delegated Act on criteria for identifying antimicrobial medicines reserved for treating humans. 

  • The HPRA expects to begin exporting national data to the Union Product Database (UPD) in September 2020. The HPRA is making significant investments in its IT infrastructure to allow for ongoing exports to the UPD.

May Update 

Highlights in the May update include:

  • The European Medicines Agency has published a guide on submitting information on veterinary medicinal products to the Union Product Database.

  • The CMDv has published a dedicated webpage for information relating to the new Regulation, which includes four best practice guides released for public consultation.

  • The European Commission has highlighted the importance of uploading legacy data to the Union Product Database and has revised the information in Annex II of the Regulation to provide details on the data requirements for veterinary medicines.

  • A video recording and presentation slides from a HPRA webinar held on 14 May are available to download. The webinar covered the topic of registration requirements for medicines qualifying under Article 5 of the Regulation.

  • The HPRA has contacted marketing authorisation holders to request information on the qualified person for pharmacovigilance (QPPV), which is required to complete submission of legacy data to the UPD.

April Update 

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.

March Update

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.


February Update 

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.


January Update 

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.