#1602779
Coinbhinsiún maidir le Pharmacopoeia Eorpach a Mhionsaothrú.
CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA.
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8 dtoradh in 7 ndoiciméad
#741894
Cuimseoidh tagairtí sa Rialachán seo do chaighdeáin chomhchuibhithe freisin monagraif an Pharmacopoeia Eorpaigh arna nglacadh i gcomhréir leis an gCoinbhinsiún maidir le Pharmacopoeia Eorpach a Mhionsaothrú, go háirithe maidir le huamanna máinliacha agus maidir le hidirghníomhaíocht idir táirgí íocshláinte agus ábhair a úsáidtear i bhfeistí ina bhfuil táirgí íocshláinte den sórt sin, ar choinníoll gur foilsíodh na tagairtí do na monagraif sin in Iris Oifigiúil an Aontais Eorpaigh.
References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.
#745727
Áireofar freisin i dtagairtí sa Rialachán seo do chaighdeáin chomhchuibhithe monagraif an Pharmacopoeia Eorpach arna nglacadh i gcomhréir leis an gCoinbhinsiún maidir le Pharmacopoeia Eorpach a Mhionsaothrú, ar choinníoll gur foilsíodh tagairtí do na monagraif sin in Iris Oifigiúil an Aontais Eorpaigh.
References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, provided that references to those monographs have been published in the Official Journal of the European Union.
#1735126
Chun a fhíorú an bhfuil na sonraí a chuirtear isteach chun deimhniú oiriúnachta a fháil ag comhlíonadh mhonagraif Pharmacopoeia Eorpach, féadfaidh an comhlacht um chaighdeánú le haghaidh ainmníochtaí agus noirm cháilíochta, de réir bhrí an Choinbhinsiúin ar fhorbairt Pharmacopoeia Eorpach arna glacadh le Cinneadh 94/358/CE (an Stiúrthóireacht Eorpach um Cháilíocht Leigheasra agus Cúraim Sláinte (“EDQM”)), féadfaidh sé iarraidh ar an gCoimisiún nó ar an nGníomhaireacht cigireacht arna déanamh ag údarás inniúil a iarraidh i gcás ina bhfuil an t-ábhar tosaigh lena mbaineann faoi réir monagraf de chuid Pharmacopoeia Eorpach.
In order to verify whether the data submitted for obtaining a certificate of suitability complies with the monographs of the European Pharmacopoeia, the standardisation body for nomenclatures and quality norms within the meaning of the Convention on the elaboration of a European Pharmacopoeia accepted by Council Decision 94/358/EC (European Directorate for the Quality of Medicines and Healthcare (‘EDQM’)) may ask the Commission or the Agency to request an inspection by a competent authority when the starting material concerned is subject to a European Pharmacopoeia monograph.
#1735440
Cinneadh 94/358/CE ón gComhairle an 16 Meitheamh 1994 lena nglactar, thar ceann an Chomhphobail Eorpaigh, an Coinbhinsiúin maidir le forbairt Pharmacopoeia Eorpach (IO L 158, 25.6.1994, lch. 17).
Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
#2215024
Cinneadh 94/358/CE ón gComhairle an 16 Meitheamh 1994 lena nglactar, thar ceann an Chomhphobail Eorpaigh, an Coinbhinsiúin maidir le forbairt Pharmacopoeia Eorpach (IO L 158, 25.6.1994, lch. 17).
Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
#2667037
Cinneadh 94/358/CE ón gComhairle an 16 Meitheamh 1994 lena nglactar, thar ceann an Chomhphobail Eorpaigh, an Coinbhinsiúin maidir le forbairt Pharmacopoeia Eorpach (IO L 158, 25.6.1994, lch. 17).
Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
#3155508
Cinneadh 94/358/CE ón gComhairle an 16 Meitheamh 1994 lena nglactar, thar ceann an Chomhphobail Eorpaigh, an Coinbhinsiúin maidir le forbairt Pharmacopoeia Eorpach (IO L 158, 25.6.1994, lch. 17).
Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).