Monthly update on implementation of the new veterinary regulation - December 2021

Update by the EMA

The EMA released the eight edition of its newsletter on progress towards implementation on 29 November. The EMA has also released a Q&A for industry users about the Union Product Database.

The CVMP adopted a Q&A document on the requirements for pre-clinical studies that are submitted in support of new applications for marketing authorisation. The document clarifies that compliance with GLP is only required for pre-clinical safety studies. More information is available from the EMA.

Update by the CMDv

Another two Best Practice Guides (BPGs) have recently been released for public consultation and are available on the CMDv webpageThese include the BPG for handling applications for marketing authorisations for veterinary medicinal products in exceptional circumstances (national, mutual recognition and decentralised procedures) and the BPG for the CMDv tasks related to Pharmacovigilance. The deadline for comments is the 20 January 2022.

Following a CMDv review of the feedback received during the public consultation process, final versions of the BPGs for the Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and Subsequent Recognition Procedure (SRP) are now published on the CMDv webpage.

Update by the European Commission

The European Commission has advised the EMA that the recommendation for the reserved list of antimicrobials to be reserved for human use for the relevant implementing act should be submitted by the end of February 2022. Discussions with Member States will commence in March. The EMA recommendation for the list of antimicrobials that may be used under the new cascade principles is expected to be submitted to the Commission by the end of March. 

Update by the HPRA

The HPRA is progressing with the upload of legacy product data to the Union Product Database (UPD). Our goal is to complete the exercise in advance of 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, and then provide the details to the HPRA. If this does not happen, it will not be possible for the HPRA to upload the required information and your product data will not appear on the UPD.

The Department of Agriculture, Food and the Marine (DAFM) has informed the HPRA that the new national legislation required to support the implementation of the new veterinary regulation is to be available in three parts, one of which will require an amendment of the primary legislation. While certain legislation is expected to be available by 28 January 2022, two components will be delayed. Further information is expected to be available on the DAFM website DAFM has updated its list of questions concerning the changes to the prescription requirements for antiparasitics for food-producing animals. Although the requirement for a veterinary prescription has been postponed until 1 June 2022, the products concerned must be released from the site of manufacture in the new livery, which bears the prescription-only medicine supply route from 28 January 2022.

The HPRA expects to issue the next web update of this kind to stakeholders at the end of January, once the Regulation applies from 28 January 2022. Thereafter, future updates will be issued only when there are developments to report.

The HPRA would like to wish all our stakeholders a very happy Christmas and festive season. We look forward to working with everyone as we embark on the change to the new processes on 28 January 2022. As ever, we are available to address any concerns and challenges via newvetreg@hpra.ie and our usual contact points.