Monthly update on implementation of the New Veterinary Regulation — September 2021

Update by the EMA

The Union Product Database went live on 27 July and is now available to national agencies to upload legacy product data. This will be conducted in a phased approach, with Reference Member States to upload data on the relevant medicines by 31 October, and Concerned Member States to upload complementary national data on the products concerned thereafter. The HPRA expects to fulfil these milestones.

Work on the development of the manufacturer and wholesale distributors database and the Union pharmacovigilance database are progressing to plan. Regarding the development of the antimicrobial sales and use database, the finalisation plans must await the publication of the Implementing Act, which is expected towards the end of 2022.

Update by the Committee for Medicinal Products for Veterinary Use (CVMP)

The Committee adopted a draft reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6 (EMA/CVMP/ERA/622045/2020) for a 3-month period of public consultation. This reflection paper has been developed to provide guidance on when an environmental risk assessment can be requested by competent authorities in the frame of marketing authorisation applications for generic veterinary medicinal products.

Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary

The joint EMA/CMDv guidance on the details of the classification of variations requiring assessment has now been published on the CMDv pages of the HMA website in the dedicated section relating to the implementation of Regulation 2019/6. The Annex to this guidance provides a list of variations, which require assessment according to Article 62 of Regulation (EU) 2019/6 and indicates, where appropriate, the timetable proposed to be applied, the data to be submitted and how this data should be documented.

Six Best Practice Guides (BPGs) have now been released for public consultation and are available on the CMDv webpage. Included, amongst the six, are the BPGs for the Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and Subsequent Recognition Procedure (SRP). The deadline for comments is 29 October 2021.

Update by the EU Commission

On 16 September, the European Parliament rejected a proposal to ban polymyxins, macrolides, fluoroquinolones and third and fourth generation cephalosporins from use in animals. This development will allow the EU Commission to proceed to elaborate a Delegated Act as to which criteria should be used to determine those antimicrobials to be reserved for treatment of certain infections in humans (reserved solely for human use). Consequently, an Implementing Act on the list of antimicrobials that are to be reserved for human use is expected to be elaborated before the end of January 2022.

Update by the HPRA

Registration is now open for the HPRA information day on the implementation of the new veterinary regulation, which will take place on 28 October 2021. This will be a virtual meeting and is free of charge.

The HPRA continues to make progress in adapting its internal IT systems and processes to meet the requirements of Regulation 2019/6. The HPRA has further engaged with the Department of Agriculture, Food and the Marine concerning the elaboration of national legislation to replace SI No 786 of 2007.

HPRA clarification of renewals of marketing authorisations

To process renewals due before 28 July 2022

All pending applications for renewal of marketing authorisation which have an expiration date within six months of the date of application of Regulation 2019/6 (i.e. renewals that fall due before 28 July 2022) are required to be submitted six months in advance of the expiry of the authorisation. Such applications will be assessed in accordance with the current Directive 2001/82/EC, as amended.

To process renewals due after 28 July 2022

The legal position is still under discussion with the European Commission. The HPRA will contact MAHs in due course regarding the process for renewals of marketing authorisation that are due to expire after 28 July 2022.