#3221266
Déanfar meastóireacht ar dhoiciméadacht PMF laistigh den iarratas ar údarú margaíochta láraithe.
The PMF documentation shall be evaluated within the centralised marketing authorisation application.
Scag na torthaí
Bailiúcháin
6 thoradh i ndoiciméad amháin
#3221270
Beidh feidhm ag táille EUR 20400 maidir le hiarratas ar athbhreithniú agus athdheimhniú bliantúil ar PMF a bhféadfaidh aon athrú de bhun Rialachán (CE) Uimh. 1234/2008 a chuirtear isteach go comhuaineach leis an iarratas ar athdheimhniú bliantúil ar PMF a bheith san áireamh leis.
A fee of EUR 20400 shall apply to an application for review and annual re-certification of a PMF which may include any variation pursuant to Regulation (EC) No 1234/2008 submitted simultaneously with the application for a PMF annual re-certification.
#3221262
Deimhniú um chomhlíonadh reachtaíocht an Aontais le haghaidh máistirchomhad plasma (PMF) i gcomhréir le Cuid III d’Iarscríbhinn I a ghabhann le Treoir 2001/83/CE
Certification of compliance with Union legislation for a plasma master file (PMF) in accordance with Part III of Annex I to Directive 2001/83/EC
#3221263
Beidh feidhm ag táille EUR 69000 maidir le hiarratas ar athbhreithniú ar PMF agus a dheimhniú tosaigh de bhun Chuid III, pointe 1.1, d’Iarscríbhinn I a ghabhann le Treoir 2001/83/CE.
A fee of EUR 69000 shall apply to an application for review of a PMF and its initial certification pursuant to Part III, point 1.1, of Annex I to Directive 2001/83/EC.
#3221265
Beidh feidhm ag muirear EUR 6900 maidir le deimhniú PMF tosaigh a eisiúint i gcás ina gcuirtear isteach go comhuaineach é le hiarratas ar údarú margaíochta le haghaidh táirge íocshláinte faoin nós imeachta láraithe.
A charge of EUR 6900 shall apply to the issuing of an initial PMF certification where it is submitted simultaneously with an application for a marketing authorisation for a medicinal product under the centralised procedure.
#3221267
Beidh feidhm ag táille EUR 12800 maidir le hiarratas ar athbhreithniú agus deimhniú ar mhórathrú de chineál II ar PMF de bhun Rialachán (CE) Uimh. 1234/2008.
A fee of EUR 12800 shall apply to an application for review and certification of a major variation of type II to the PMF pursuant to Regulation (EC) No 1234/2008.