IFAH-Europe at TOPRA Conference:
supporting new veterinary medicines legislation and addressing some concerns

Brussels, Belgium, 10 November 2023 : IFAH-Europe reiterated its support for the new
EU veterinary legislation while expressing some conce rns during the TOPRA1 Conference
of 26 to 28 October on the new human and veterinary medicines legislation entitled
‘Impact 2005: ‘Getting started with the New Legislation’. IFAH-Europe also used the
event to launch its revised brochure: ‘The Marketing Authorisation Process for Veterinary
Medicinal Products in Europe’.

The three-day conference was well attended, the first two days covering both human issues
and issues common to both the human and veterinary sectors, the last half day being
dedicated to veterinary issues. The veterinary issues were presented by the EMEA2, the
European Commission, the Irish Medicines Board (for VMRFG3), and IFAH-Europe
representing the European veterinary medicinal products industry.

Rick Clayton, IFAH-Europe’s Senior Technical Manager explained that ‘…the industry
welcomes the new legislation but insists on the need to reduce the bureaucratic and
financial burden.’
During the panel discussion, the animal health industry stressed the need to recognise that
the veterinary sector is very different from the human sector, particularly in terms of
1 TOPRA is The Organisation for Professionals in Regulatory Affairs
2 The EMEA is the European Medicines Agency (human and veterinary)
3 The VMRFG is the Veterinary Mutual Recognition Facilitation Group resources.
As such, it is not automatically feasible to use models developed in the human
sector in the veterinary sector. Further concerns were expressed at the European
Commission’s interpretation of the new legislation covering renewals, which would mean
that existing products would have to have one more renewal after the date of
implementation of the new legislation. The industry firmly voiced its disagreement with
that position.

Rick Clayton added: ‘This was an important event, very well organised by TOPRA with
the sponsorship of the Commission. The format was well structured to allow a frank and
open discussion.’


Notes to Editors:

IFAH-Europe is the representative body of manufacturers of veterinary medicines, vaccines and
other animal health products in Europe.
For further information on IFAH-Europe, please visit http://www.ifahsec.org/Europe

For further information on the issue covered by this Press Release, please contact Diane Chevreux,
Communications Advisor

Rue Defacqz, 1
B-1000 Brussels
Tel.: +32 (0) 2 543 67
Fax: +32 (0) 2 537 0049
E-mail: [email protected]

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