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

Update of note by the EMA

The EMA reports good progress in the development of projects under its  veterinary regulation IT development scheme. The EU Implementation Guide on Veterinary Medicines Product Data in the Union Product Database was published on 12 May. The guide provides information on the data elements and associated business rules for the submission of information on veterinary medicinal products into the Union Product Database (UPD).  Member States are expected to commence uploading product legacy data from July.

The fifth EMA newsletter providing information on the new Regulation is now available.

The EMA is hosting a webinar for veterinarians on 23 June on the classification of critically important antimicrobials for use in livestock and companion animals as set out by Regulation 2019/6. Attendance is free of charge and details of registration are available here.

Update of note by the CMDv

The CMDv adopted a joint EMA/CMDv guidance on the details of the classification of variations requiring assessment, according to Article 62 of Regulation (EU) 2019/6.  The guidance includes information on the documentation to be submitted pursuant to those variations (EMA/CMDv/190673/2021). The document will be sent to the Heads of Medicines Agencies for endorsement and published on the EMA’s website in due course.

A dedicated webpage relating to the implementation of Regulation 2019/6 has been set up on the CMDv pages of the HMA website. Four best practice guides have now been released for public consultation and are available on the webpage.

Update of note by the European Commission

The European Commission has written to the Ministers for Agriculture in Member States, stressing that the envisaged functionalities of the UPD and other databases can be achieved only when Member States complete the legacy data upload.

The European Commission published a revised Annex II to Regulation 2019/6, called Commission Delegated Regulation EU 2021/805. This technical document lays out the data requirements for various types of veterinary medicines, including biological medicines and novel therapy medicines. It will replace Directive 2000/9/EC and applies from 28 January 2022.

Update of note by the HPRA

The HPRA held a webinar for companies and veterinary manufacturers on 14 May to provide information on veterinary medicines for aquarium and pond fish, caged birds, homing pigeons, terrarium animals, small rodents, ferret and pet rabbits that qualify for registration under Article 5(6) of Regulation 2019/6. A recording of the webinar, together with other relevant information, is available on the webinar webpage.

QPPV data requirement for the Union Product Database

The HPRA requires information on the qualified person for pharmacovigilance (the QPPV) in respect of ‘legacy’ product data that must be uploaded to the UPD.  ‘Legacy’ data is defined as any data on a veterinary medicinal product authorised in a Member State with a marketing authorisation or registration valid before 28 January 2022. In order to meet this requirement, the HPRA has written to marketing authorisation holders shortly to request specific QPPV information. It is vital that we receive the data and have time to update our systems, as we will be unable to complete the submission of the legacy data to the UPD without these details. If you have any queries, please do not hesitate to contact us at newvetreg@hpra.ie.