Developments on the implementation of Regulation 2019/6  — Monthly 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 will apply in all EU Member States on 28 January 2022.

In 2021, we will share monthly updates on this webpage to communicate information on key legislative, regulatory, ICT and procedural changes relating to veterinary medicinal products.

The updates will summarise relevant developments from the European Commission, the European Medicines Agency and the Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary. The updates will 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.

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

• 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 European Commission has adopted two implementing acts — Regulation 2021/16 on the Union Product Database (UPD) and Regulation 2021/17 on the list of variations that do not require assessment. 

• The European Medicines Agency has published the UPD Access Policy and the EU vet implementation guide on veterinary product data in the UPD. 

• 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.