Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

4 thoradh

  1. AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|crop production · AGRICULTURE, FORESTRY AND FISHERIES|forestry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|intellectual property

    #614195

    IATE #916359
    máistirdheimhniú Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Stammzertifikat
    de
    master certificate
    en
    Sainmhíniú "document setting out all relevant information relating to forest reproductive material [ IATE:797267 ]" Tagairt "Forest Reproductive Material - Regulations controlling seed, cuttings and planting stock for forestry in Great Britain, Forestry Commission, http://www.forestry.gov.uk/pdf/fcfc003.pdf/$FILE/fcfc003.pdf [13.12.2012]"
    Nóta "The certificate bears a unique identity number, identifying a particular collection from a single unit of approval in the forestry authority's official register.See also: - forest reproductive material (related) [ IATE:797267 ] - plant reproductive material (broader) [ IATE:3546800 ]"
    certificat-maître | certificat maître | certificat souche
    fr
    Sainmhíniú certificat délivré, après la récolte, pour tout matériel forestier de reproduction issu de matériel forestier de base admis Tagairt COM-FR, d'après COM-document interne: SANCO-2013-80056-06-00
    Nóta "Contexte: matériels forestiers de reproduction et obtentions végétales.Le matériel forestier de reproduction (ou matériel génétique) est constitué de tous les matériels, sexués ou asexués, tels que les semences, le pollen et les boutures, à partir desquels de nouveaux arbres et de nouvelles forêts peuvent être reproduit(e)s. http://www.fao.org/forestry/seeds/11348/fr/"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688153

    IATE #3639784
    deimhniú máistirchomhaid maidir le substaintí gníomhacha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Bescheinigung über die Wirkstoff-Stammdokumentation
    de
    active substance master file certificate
    en
    Sainmhíniú certificate granted by the European Medicines Agency (EMA) in accordance with Article 25 of Directive xxx in cases where the relevant data on the active substance concerned are not already covered by a monograph of the European Pharmacopoeia and which can be used instead of submitting the relevant data on a chemical active substance of a medicinal product required in accordance with Annex II to this Directive Tagairt "COM-Terminology Coordination, based on:Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
    Nóta The active substance master file certificate shall cover all the information required in Annex II on the active substance
    certificat du dossier permanent de la substance active
    fr
    Sainmhíniú certificat délivré par l’Agence conformément à l'article 25 de la directive xxx dans les cas où les données pertinentes sur la substance active concernée ne sont pas déjà couvertes par une monographie de la Pharmacopée européenne et sur lequel peuvent s'appuyer les demandeurs d’autorisations de mise sur le marché, au lieu de fournir les données pertinentes sur une substance chimique active d’un médicament requises conformément à l’annexe II Tagairt "COM-FR d'après: Proposition de directive du Parlement européen et du Conseil instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE, COM(2023) 192"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688338

    IATE #3640684
    deimhniú breise faoin máistirchomhad cáilíochta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'mar is gá i gcomhréir le hIarscríbhinn II, brath ar mháistirchomhad breise cáilíochta, deimhniú breise faoin máistirchomhad cáilíochta arna dheonú ag an nGníomhaireacht i gcomhréir leis an Airteagal (‘deimhniú breise faoin máistirchomhaid cáilíochta’) nó deimhniú lena ndeimhnítear go bhfuil cáilíocht na substainte gníomhaí lena mbaineann rialaithe go cuí ag an monagraf ábhartha den Pharmacopeia Eorpach.' Tagairt "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"
    additional quality master file certificate
    en
    Sainmhíniú certificate granted by the European Medicines Agency in accordance with Article 25 of Directive xxx in cases where the relevant data on an active substance other than a chemical active substance or on other substances present or used in the manufacture of a medicinal product concerned are not already covered by a monograph of the European Pharmacopeia and which can be used instead of submitting the relevant data on such substance required in accordance with Annex II to this Directive Tagairt "COM-Terminology Coordination, based on: Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"