Brexit deal ‘im­per­a­tive’ for vet medicines

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TO en­sure con­ti­nu­ity of sup­ply of vet­eri­nary medicines in the UK and through­out the EU, a fi­nal agree­ment on the fu­ture re­la­tion­ship be­tween the UK and the EU re­mains im­per­a­tive, said the Na­tional Of­fice of An­i­mal Health (NOAH).

The or­gan­i­sa­tion, which rep­re­sents the UK an­i­mal health in­dus­try, said it was pleased to have more in­for­ma­tion for busi­nesses on the ac­tion the gov­ern­ment will take in re­la­tion to reg­is­tra­tion and reg­u­la­tion of an­i­mal medicines should there be no Brexit deal.

The gov­ern­ment ad­vice, pub­lished on Septem­ber 24, cov­ers is­sues such as vet­eri­nary medicines batch test­ing and cer­ti­fi­ca­tion; reg­u­la­tion (mar­ket­ing au­tho­ri­sa­tions, vet­eri­nary gener­ics, par­al­lel im­ports and MRLs); the im­por­tant drug safety phar­ma­covig­i­lance sys­tems and the devel­op­ment of IT sys­tems that help with the reg­u­la­tion of vet­eri­nary medicines. There is also a no­tice on pet travel.

But NOAH chair Gaynor Hillier said as the dead­line be­comes closer, the sec­tor, like other busi­nesses in the UK, needs clar­ity.

‘These no­tices do show some wel­come prag­ma­tism from the UK, such as on batch test­ing and cer­ti­fi­ca­tion, which will be help­ful in main­tain­ing con­ti­nu­ity of sup­ply.

‘We also wel­come the re­stat­ing of the gov­ern­ment’s com­mit­ment to ne­go­ti­at­ing terms in which we can re­main ac­tive in the Euro­pean Medi- cines Agency (EMA) and Euro­pean reg­u­la­tory net­work – which is of course de­pen­dent on an over­all deal.

‘We ad­mire the hard work and plan­ning that aims to en­sure that there will be a fully op­er­a­tional IT sys­tem in place that will en­able com­pa­nies to sub­mit in­for­ma­tion elec­tron­i­cally for mar­ket­ing au­tho­ri­sa­tion ap­pli­ca­tions and in re­la­tion to phar­ma­covig­i­lance.

‘But a prac­ti­cal mech­a­nism to share, re­ceive and com­mu­ni­cate alerts with the Euro­pean reg­u­la­tory net­work in re­la­tion to po­ten­tial phar­ma­covig­i­lance is­sues re­mains im­per­a­tive, to help sup­port an­i­mal, hu­man and en­vi­ron­men­tal safety here and in Europe.

‘Much of the gov­ern­ment ad­vice ap­plies to the short to medium term, to cover the im­me­di­ate pe­riod af­ter March 29, 2019, if there is no deal.

‘If no deal hap­pens, then mov­ing for­ward there would be con­cerns re­lat­ing to po­ten­tial im­pact on in­no­va­tion and po­ten­tially on prod­uct avail­abil­ity and choice for UK pre­scribers and an­i­mal keep­ers, as there may be fewer new medicines en­ter­ing the UK mar­ket and fewer im­prove­ments to ex­ist­ing medicines,’ she said. NOAH is also con­cerned that there is no ad­vice yet re­lat­ing to those prod­ucts cur­rently reg­u­lated en­tirely through the Euro­pean Food Safety Au­thor­ity (EFSA), such as spec­i­fied feed ad­di­tives, for which there is no di­rect UK equiv­a­lent.

Above: Gaynor Hillier

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