Gaois

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4 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688242

    IATE #3639969
    deimhniú oiriúnachta leis na monagraif de chuid Pharmacopoeia Eorpach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Laistigh den nós imeachta le haghaidh ‘Deimhniú Oiriúnachta leis na monagraif de chuid Pharmacopoeia Eorpach’, fíoraíonn an Stiúrthóireacht Eorpach um Cháilíocht Leigheasra agus Cúraim Sláinte trí bhíthin cigireachtaí cibé acu a dheimhnítear nó nach ndeimhnítear leis na sonraí arna gcur isteach ag an iarratasóir arna bhunú ag Comhairle na hEorpa oiriúnacht monagraf chun an íonacht cheimiceach ...' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    Certification of Suitability to the monographs of the European Pharmacopoeia
    en
    Definition procedure established in 1994 for the control of the chemical purity of pharmaceutical substances, of products posing a risk of transmitting transmissible spongiform encephalopathy as well as of herbal drugs and herbal drug preparations Reference "COM-Terminology Coordination, based on: Council of Europe. European Directorate for the Quality of Medicines & HealthCare. Medicines Certification of Suitability (CEP). About the Procedure. 'Certification - Background & Legal Framework' (19.6.2023)"
  2. SOCIAL QUESTIONS|health|medical science

    #667403

    IATE #3628076
    monagraf SoHO EDQM Reference "Togra le haghaidh Rialachán maidir le caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoracha 2002/98/CE agus 2004/23/CE,CELEX:52022PC0338/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    monagraf na Stiúrthóireachta Eorpaí um Cháilíocht Leigheasra SoHO Reference "Togra le haghaidh Rialachán maidir le caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoracha 2002/98/CE agus 2004/23/CE,CELEX:52022PC0338/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Definition sonraíocht de pharaiméadair cháilíochta chriticiúla maidir le hullmhóid áirithe SoHO arna sainmhíniú ag an Stiúrthóireacht Eorpach um Cháilíocht Leigheasra agus Cúraim Sláinte de chuid Chomhairle na hEorpa Reference "Togra le haghaidh Rialachán maidir le caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoracha 2002/98/CE agus 2004/23/CE,CELEX:52022PC0338/GA"
    EDQM SoHO monograph
    en
    Definition "specification of the critical quality parameters of a particular 'SoHO preparation' defined by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe" Reference "Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application, COM/2022/338 final"
  3. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #682913

    IATE #3535603
    monagraf de luibheanna an Aontais Eorpaigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Gemeinschaftliche Pflanzenmonografie
    de
    European Union herbal monograph | EU herbal monograph | Union herbal monograph | Community herbal monograph | Community herbal monograph for herbal medicinal products
    en
    Definition "monograph that contains the HMPC's scientific opinion on safety and efficacy data about a herbal substance and its preparations intended for medicinal use" Reference "COM-Terminology Coordination, based on: EMA. Human Regulatory. 'European Union monographs and list entries' (5.6.2023)"
    monographie communautaire de plantes médicinales
    fr
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687578

    IATE #3633864
    córas monagraif Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Dá bhrí sin, ba cheart don Choimisiún tuarascáil a chur faoi bhráid Pharlaimint na hEorpa agus na Comhairle, ar tuarascáil í lena scrúdófar a indéanta a bheadh córas monagraif den sórt sin agus roghanna eile chun measúnú riosca don chomhshaol a dhéanamh ar tháirgí íocshláinte tréidliachta agus, más iomchuí, ba cheart togra reachtach a bheith ag gabháil léi.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    córas athbhreithniúcháin bunaithe ar shubstaintí gníomhacha Reference "Faofa ag an gCoiste Téarmaíochta, www.tearma.ie Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    córas monagraif bunaithe ar shubstaintí gníomhacha Reference "Faofa ag an gCoiste Téarmaíochta, www.tearma.ie Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    active-substance-based review system | monograph system | active-substance-based monograph system | active substance based review system
    en
    Definition EU-wide uniform collection of relevant and high-quality environmental data for APIs used on the EU market to be used in the subsequent ecotoxicological evaluations at product level Reference "COM-Terminology Coordination, based on: REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on a feasibility study of an active-substance-based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products"