Update on implementation of the new veterinary regulation - January 2022

Update by the EMA

Training and information resources

The EMA recently provided information on the following resources which industry might find useful:

  1. Introduction to RMS services and activities

  2. Introduction to OMS services and activities

  3. Veterinary Medicines Regulation newsletters

  4. UPD implementation guide (with particular attention to Chapter 7)

  5. EU VICH AER implementation guide

  6. VICH schema

  7. EVV – webinars for industry and national competent authorities

  8. Introduction to UPD

  9. UPD Q&As for industry

  10. Integration of EudraGMDP with OMS

Newsletter - IT veterinary systems

The ninth issue of the EMA Newsletter on implementation of the IT veterinary systems associated with Regulation 2019/6 is now available. 

UPD update

The EMA has advised that the expected UPD functionality will not be complete for two to three weeks after go-live on 28 January 2022. Member States have encountered difficulties in uploading products to the UPD over recent weeks, meaning that not all products were uploaded to the system before go-live. These issues are not unique to the HPRA and are impacting the upload of products in a number of countries. The EMA has also advised that UPD functionality in respect of variations not requiring assessment, as well as pharmacovigilance signal management, will not be fully operational until the legacy product upload has been completed by all Member States; this might not be fully completed until late February or early March. Given the pressure on Member States and the issues that have been encountered in uploading the products to the UPD, it is expected that improvements to the data quality will be needed over the coming months.

Marketing authorisation holders are requested not to attempt to submit VNRAs until such time as the EMA has provided an update on the completeness of the UPD with national product data. The EMA has advised that it is preparing a list frequently asked questions and stakeholders should consult that list before contacting anyone. If you have queries relating to the UPD, for example, if you cannot see a particular product in the system or cannot engage with the system as a ‘super user’, you should contact VMP-Regulation User Support Service and select the ‘Union Product Database’ tab on the left of the page.

Separately, the EMA has advised that the UPD functionality will not be complete for parallel traded product and for homeopathic products until 18 February.

Update by the CMDv

The CMDv has prepared and will soon publish four separate templates for new Marketing Authorisation (MA) procedures, which will assist applicants in their new responsibility for compiling list of questions (LoQs) during the significant milestones of Decentralised Procedures (DCPs), Mutual Recognition Procedures (MRPs) and Subsequent Recognition Procedures (SRPs). The four separate templates include LOQ for CMS comments, cLOQ (Compiled LoQ) for DCP phase I, cLOQ for DCP phase II and cLOQ for MRP and SRP.

To provide assistance to applicants/MAHs in terms of preparing their SPC and labelling packages for submission, the BPG for the processing of SPC, Labelling and Package leaflet and the preparation of Multilingual/-country Packaging provided in support of MRP/DCP/SRP and Variations has been updated and released for public consultation. The deadline for comments is 28 January 2022.

The CMDv has published a dedicated veterinary Question and Answer document, which addresses a number of questions relating to the submission and classification of variations under Regulation 2019/6.

Update by the European Commission

At the end of December 2021, the European Commission advised of a restrictive interpretation of the management of transitional measures on packaging and labelling of existing products, which would have meant that they could no longer be released to the market in existing livery post 28 January 2022. The HPRA and other agencies demurred from the Commission’s interpretation and there was significant opposition by stakeholders. However, following intense discussion by the EU network of medicines agencies the Commission published a statement on Article 152(2) of Regulation 2019/6 and is preparing a proposal for a legal act that would allow MAHs to continue to place veterinary medicinal products complying with the packaging and labelling requirements of Directive 2001/82/EU or Regulation 726/2004 on the market until 29 January 2027.  Once adopted, the legal act would apply retroactively, from 28 January 2022.

The European Commission has advised that the Implementing Act that sets out the list of antibiotics to be reserved for human use is expected to be in place by the end of March. The legislation on restrictions to the use of antibiotics used under the cascade is expected to be ready by the end of April.

Update by the HPRA

The HPRA has completed the upload of ‘common data’ for over 600 products for which Ireland was Reference Member State. However, by the go-live date it has not been possible to complete the upload of the national specific data for these products. Work to upload them, together with approximately 1400 nationally authorised veterinary medicines has commenced and is expected to continue over the coming weeks. This work has been given priority status; if you have queries relating to the UPD please do not contact the HPRA as we are not in a position to address them (see earlier UPD update above). However, if you have regulatory queries for the HPRA, you may contact the HPRA at newvetreg@hpra.ie.

The Department of Agriculture, Food and the Marine (DAFM) provided new national legislation (SI No 36 of 2022) on 27 January 2022. It will be available on the Irish Statute book in the coming days. This legislation revoked SI No 786 of 2007 and gave effect to aspects of Regulation 2019/6 which are open to Member States to choose a legal framework.  Further national legislation is planned by DAFM for enactment during the year:

  1. A new legal Act to give effect to a new national electronic prescription and dispensing system. This will require primary legislation and will come into effect later this year.

  2. A legal instrument to give effect to any remaining measures deemed relevant for the control of veterinary medicines and treated animals. This will come into effect later this year.

With the go-live application of the Regulation on 28 January 2022, this blog will be updated on an as needed basis going forward. The expectation is that the next issue will be uploaded by 31 March.