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  1. #2113347

    stair an táirge, lena n-áirítear na taifid agus na doiciméid a bhaineann leis na bealaí dáilte a úsáidtear;

    its history, including the records and documents relating to the distribution channels used;

    Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

  2. #2344522

    Chuir Comhghuaillíocht na n-úsáideoirí na barúlacha céanna isteach maidir le húsáidí deiridh, inmhalartacht, próisis mhonaraíochta agus bealaí dáilte an táirge.

    The same comments were also submitted by the Coalition of users on the product’s end-uses, interchangeability, manufacturing process and distribution channels.

    Commission Implementing Regulation (EU) 2022/547 of 5 April 2022 imposing a definitive anti-dumping duty on imports of superabsorbent polymers originating in the Republic of Korea

  3. #2344528

    I dteannta leis na saintréithe ar tugadh tuairisc orthu mar tháirgí ‘sonraíochta’, tá difríocht sa bhreis maidir le bealaí dáilte, próiseas monaraíochta agus costais táirgeachta i gceist le táirgí ‘comhfhorbartha’.

    In addition to the characteristics already described for “spec-in” products, “co-developed” products present further differences in terms of distribution channels, manufacturing process and costs of production.

    Commission Implementing Regulation (EU) 2022/547 of 5 April 2022 imposing a definitive anti-dumping duty on imports of superabsorbent polymers originating in the Republic of Korea

  4. #2505741

    Tá gá le ham breise chun gur féidir an táirgeacht atá sa stoc agus sna bealaí dáilte a dhíol amach.

    Additional time is necessary to allow for the production in stock and in the distribution channels to be sold out.

    Commission Delegated Regulation (EU) 2022/1398 of 8 June 2022 amending Regulation (EU) 2019/2144 of the European Parliament and of the Council to take into account technical progress and regulatory developments concerning amendments to Vehicle Regulations adopted in the context of the United Nations Economic Commission for Europe (Text with EEA relevance)

  5. #294068

    3.7.2.5.6. Maidir le staidéir a úsáideann bealaí dáilte amhail instealladh infhéitheach nó inpheireatóineach, agus a fhágann go nochtar na horgáin atáirgthe do leibhéil den tsubstaint tástála atá ró-ard ar fad, nó go ndéantar damáiste logánta do na horgáin atáirgthe, lena n-áirítear greannú, caithfear iad a léirmhíniú go han-chúramach agus go hiondúil ní bhíonn staidéir den sórt sin ina mbonn aicmithe leo féin.

    3.7.2.5.6. Studies involving routes of administration such as intravenous or intraperitoneal injection, which result in exposure of the reproductive organs to unrealistically high levels of the test substance, or elicit local damage to the reproductive organs, including irritation, must be interpreted with extreme caution and on their own are not normally the basis for classification.

    Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

  6. #2340726

    Ina theannta sin, chun a áirithiú go nginfear faisnéis úsáideach ar thocsaineacht atáirgthe agus forbraíochta, ba cheart na speicis ainmhithe a mholtar agus na bealaí dáilte le haghaidh tástála a mholtar a chur le pointe 8.7.1, agus i dtaca le rialacha sonracha áirithe maidir le hoiriúnú, rialacha atá sna ceanglais faisnéise caighdeánaí, ba cheart iad a shoiléiriú.

    In addition, to ensure that useful information on reproductive and developmental toxicity is generated, the preferred animal species and the preferred administration routes for testing should be added to point 8.7.1, while certain specific rules for adaptation from the standard information requirements should be clarified.

    Commission Regulation (EU) 2022/477 of 24 March 2022 amending Annexes VI to X to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)

  7. #2340730

    Ina theannta sin, na ceanglais faisnéise i bpointe 8.7.2 maidir le tástáil tocsaineachta forbraíochta réamhbhreithe sa chéad agus sa dara speiceas agus i bpointe 8.7.3 le haghaidh Staidéir Aon Ghlúine Sínte maidir le Tocsaineacht Atáirgthe ba cheart na ceanglais sin a shoiléiriú maidir leis na speicis ainmhithe a mholtar agus na bealaí dáilte a mholtar le haghaidh na tástála, mar aon le haon imeacht ó na rialacha ginearálta sin a d’fhéadfadh a bheith ann.

    In addition, the information requirements in point 8.7.2 on testing for pre-natal developmental toxicity in a first and second species and in point 8.7.3 for Extended One-Generation Reproductive Toxicity studies should be clarified with regard to the preferred animal species and the preferred administration routes for testing, as well as with regard to the possible deviations from the general rules.

    Commission Regulation (EU) 2022/477 of 24 March 2022 amending Annexes VI to X to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)

  8. #2340737

    Ina theannta sin, na ceanglais faisnéise maidir le Staidéar tocsaineachta forbraíochta réamhbhreithe agus Staidéar Aon Ghlúine Sínte maidir le Tocsaineacht Atáirgthe, ba cheart na ceanglais sin a leasú chun a shoiléiriú gur gá staidéar a dhéanamh ar an dara speiceas agus gur gá rogha an dara speiceas a bheith ann mar aon leis na bealaí dáilte a mholtar maidir le tástáil agus imeacht ó na rialacha ginearálta.

    In addition, the information requirements on pre-natal developmental toxicity and Extended One-Generation Reproductive Toxicity studies should be amended to clarify the need for a study in, and the choice of, a second species, as well as the preferred administration routes for testing and the deviations from the general rules.

    Commission Regulation (EU) 2022/477 of 24 March 2022 amending Annexes VI to X to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)

  9. #2344530

    D’iarr LG Chem freisin go bhfágfaí bealaí dáilte sonracha le haghaidh ceannacháin fhadtéarmacha agus conarthaí leithdháilte domhanda amach as raon feidhme an táirge lena mbaineann toisc nach bhfuil siad san iomaíocht ar mhargadh an Aontais.

    LG Chem also requested the exclusion of specific distribution channels for long-term purchases and global allocation contracts from the scope of the product concerned as they do not compete on the Union market.

    Commission Implementing Regulation (EU) 2022/547 of 5 April 2022 imposing a definitive anti-dumping duty on imports of superabsorbent polymers originating in the Republic of Korea

  10. #2717481

    D’áitigh Lioli, thairis sin, go bhfuil saintréithe éagsúla fisiciúla, ceimiceacha agus teicniúla ag leaca móra, go mbaineann bealaí dáilte éagsúla leo, agus nach mbaineann iomaíochas leo agus nach bhfuil siad inmhalartaithe le gnáth-thíleanna.

    Lioli moreover argued that large slabs had different physical, chemical and technical characteristics, different channels of distribution, and that they did not compete and were not interchangeable with standard tiles.

    Commission Implementing Regulation (EU) 2023/265 of 9 February 2023 imposing a definitive anti-dumping duty on imports of ceramic tiles originating in India and Türkiye