SOCIAL QUESTIONS|health|pharmaceutical industry
- deimhniú oiriúnachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context '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.' Reference Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA
- certificate of suitability
- en
- Comment (6) In case where starting and raw materials, active substance(s) or excipient(s) are described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia can be accepted. In such cases, the applicant shall submit a copy of the monograph accompanied by the validation of the analytical procedures contained in the monograph and by a translation where appropriate.(7) Where the active substance and/or a raw and starting material or excipient(s) are the subject of a monograph of the European Pharmacopoeia, the applicant can apply for a certificate of suitability that, where granted by the European Directorate for the Quality of Medicines, shall be presented in the relevant section of this Module. Those certificates of suitability of the monograph of the European Pharmacopoeia are deemed to replace the relevant data of the corresponding sections described in this Module. The manufacturer shall give the assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines.