UK looks to en­sure phar­ma sub­mis­sions can con­tin­ue un­der no deal Brex­it

The UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) is prepar­ing to en­sure that if the UK leaves the EU with­out a deal, phar­ma­ceu­ti­cal com­pa­nies can con­tin­ue to sub­mit reg­u­la­to­ry and no­ti­fi­ca­tion in­for­ma­tion to the UK.

“If the UK leaves the EU with no deal, the UK would no longer be part of the EU med­i­cines and med­ical de­vices reg­u­la­to­ry net­works. Sub­mis­sions re­lat­ed to hu­man med­i­cines would need to be sub­mit­ted di­rect­ly to the MHRA,” the agency said.

As per the MHRA’s con­tin­gency plan, the agency is look­ing to de­liv­er new IT sys­tems and process­es if ac­cess to the EU sys­tems is lost. “Where fea­si­ble, we are try­ing to min­imise ad­di­tion­al ad­min­is­tra­tive bur­dens and are try­ing to make any changes as sim­ple to use as pos­si­ble,” MHRA said.

The agency has put to­geth­er a new we­bi­nar for phar­ma­ceu­ti­cal com­pa­nies that make reg­u­la­to­ry sub­mis­sions and con­duct vig­i­lance ac­tiv­i­ties.

Ac­cord­ing to the pre­sen­ta­tion slides, MHRA stress­es that if a no deal EU ex­it oc­curs, the phar­ma­ceu­ti­cal in­dus­try can no longer sub­mit da­ta rel­e­vant to the UK to the MHRA via the Com­mon Eu­ro­pean Sub­mis­sion Por­tal (CE­SP) or oth­er EU por­tals.

“There­fore, we are build­ing a UK equiv­a­lent of these, but the EU por­tals will still be avail­able for EU trans­ac­tions. This UK por­tal is re­ferred to as the eS­ub­mis­sions Por­tal through­out the pre­sen­ta­tion,” MHRA said.

The we­bi­nar al­so warns that it is not pos­si­ble to move ex­ist­ing CE­SP ad­min­is­tra­tive de­tails over to our new por­tal. “We will be giv­ing more de­tail on the reg­is­tra­tion process over the next two months,” the slides say.

The we­bi­nar fo­cus­es on sub­mis­sions for hu­man med­i­cines, pe­di­atric in­ves­ti­ga­tion plans, pe­ri­od­ic safe­ty up­date re­ports and in­di­vid­ual case safe­ty re­ports.

Up­com­ing com­mu­ni­ca­tions will al­so pro­vide tai­lored in­for­ma­tion on what med­ical de­vice and med­i­c­i­nal prod­uct bro­kers will need to know, MHRA said.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

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