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8 results in 6 documents

  1. #1945218

    modh nó meicníocht na gníomhaíochta agus/nó;

    the mode or the mechanism of action; and/or

    Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)

  2. #1735945

    Ar an gcéad dul síos, déanfar cur síos imleor ar mheicníocht na gníomhaíochta agus na héifeachtaí cógaseolaíocha ar a bhfuil an t-iarratas molta bunaithe, i gcleachtas.

    First, the mechanism of action and the pharmacological effects on which the recommended application in practice is based shall be adequately described.

    Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

  3. #2480714

    Tá sainmhíniú struchtúrach agus sásra gníomhaíochta coiteann acu agus is féidir aicéatáití, aildéid nó alcóil a bheith iontu.

    They share a common structural definition and mechanism of action and can be composed of acetates, aldehydes or alcohols.

    Commission Implementing Regulation (EU) 2022/1251 of 19 July 2022 renewing the approval of the active substances Straight Chain Lepidopteran Pheromones (acetates) as low-risk active substances, and Straight Chain Lepidopteran Pheromones (aldehydes and alcohols) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

  4. #2569560

    cibé acu is feiste lipeasúcháin simplí í an fheiste nó nach ea, i.e. súchán cannúil maol, nó cibé acu a ionchorpraítear aon mheicníocht na gníomhaíochta eile léi nó nach n-ionchorpraítear, mar shampla fuinneamh léasair nó ultrafhuaim a úsáid;

    whether the device is a simple liposuction device, i.e. blunt cannula suction, or whether it incorporates any other mechanism of action, for example the use of laser energy or ultrasound;

    Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)

  5. #2859057

    Shuigh an tÚdarás t-TDI grúpa nua freisin, bunaithe ar shásra comhchoiteann gníomhaíochta is bun le héifeachtaí atáirgthe DBP, BBP agus DEHP, agus a n-acmhainneachtaí coibhneasta á gcur san áireamh.

    Based on a common mechanism of action underlying the reproductive effects of DBP, BBP and DEHP, the Authority also established a new group t-TDI, taking into account their relative potencies.

    Commission Regulation (EU) 2023/1442 of 11 July 2023 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and addition of new substances (Text with EEA relevance)

  6. #1735765

    Cuirfear faisnéis maidir le meicníocht ghníomhaíochta na substainte gníomhaí/na substaintí gníomhacha ar fáil, maille le faisnéis maidir le héifeachtaí príomha agus tánaisteacha cógasdinimiciúla chun cuidiú leis an tuiscint ar aon éifeacht dhíobhálach a bhainfeadh leis na staidéir sin ar ainmhithe.

    Information on the mechanism of action of the active substance(s) shall be provided, together with information on primary and secondary pharmacodynamic effects in order to assist in the understanding of any adverse effects in the animal studies.

    Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

  7. #1945204

    Más rud é gur comhdhúil orgánafosfair í an tsubstaint ghníomhach nó má tá fianaise ann, amhail eolas faoi mheicníocht na gníomhaíochta nó eolas ó staidéir géardháileog nó staidéir ildáileog, go bhféadfadh airíonna néarthocsaineacha a bheith ag an tsubstaint ghníomhach, beidh gá le faisnéis bhreise nó le staidéir ar leith (amhail OECD TG 424 nó OECD TG 418 nó 419 nó a gcomhionann)

    If the active substance is an organophosphorus compound or if there is an indication, knowledge of the mechanism of action or knowledge from acute or repeated dose studies that the active substance may have neurotoxic properties, additional information or specific studies (such as OECD TG 424 or OECD TG 418 or 419 or equivalent) will be required

    Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)

  8. #2049754

    Cuirfear faisnéis faoi shásra ghníomhaíochta na substainte gníomhaí/na substaintí gníomhacha ar fáil, maille le faisnéis faoi éifeachtaí príomha agus tánaisteacha cógasdinimiciúla chun cuidiú leis an tuiscint ar aon éifeacht dhíobhálach a bhainfeadh leis na staidéir sin ar ainmhithe.

    Information on the mechanism of action of the active substance(s) shall be provided, together with information on primary and secondary pharmacodynamic effects in order to assist in the understanding of any adverse effects in the animal studies.

    Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)