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3 results in 2 documents

  1. #1735837

    Le haghaidh grúpaí áirithe substaintí nó más rud é go n-áirítear i measc na n-éifeachtaí a thugtar faoi deara le linn na staidéar ildáileoige in ainmhithe athruithe táscacha, e.g., ar thocsaineacht imdhíonachta, néarathocsaineacht, nó neamhord an chórais inchrínigh, beidh gá le tuilleadh tástála, e.g. staidéir íograithe nó tástálacha le haghaidh néarathocsaineacht mhoillithe.

    For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of e.g. immunotoxicity, neurotoxicity- or, endocrine dysfunction, further testing shall be required, e.g. sensitisation studies or delayed neurotoxicity tests.

    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)

  2. #2049794

    I gcás grúpaí áirithe substaintí nó más rud é go n-áirítear i measc na n-éifeachtaí a thugtar faoi deara le linn na staidéar ildáileog in ainmhithe athruithe táscacha, mar shampla, ar thocsaineacht imdhíonachta, néarthocsaineacht, nó neamhord an chórais inchrínigh, beidh gá le tástáil bhreise, mar shampla staidéir íograithe nó tástálacha ar néarthocsaineacht mhoillithe.

    For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of, for example, immunotoxicity, neurotoxicity or endocrine dysfunction, further testing shall be required, for example, sensitisation studies or delayed neurotoxicity tests.

    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)

  3. #2050099

    I gcás grúpaí áirithe substaintí nó más rud é go n-áirítear i measc na n-éifeachtaí a thugtar faoi deara le linn na staidéar ildáileog in ainmhithe athruithe táscacha, mar shampla, ar imdhíonghineacht, tocsaineacht imdhíonachta, néarthocsaineacht, nó neamhord an chórais inchrínigh, beidh gá le tástáil bhreise, mar shampla staidéir íograithe nó tástálacha ar néarthocsaineacht mhoillithe.

    For particular groups of substances, or if the effects observed during repeated dose studies in animals include changes indicative of, for example, immunogenicity, immunotoxicity, neurotoxicity or endocrine dysfunction, further testing shall be required, for example, sensitisation studies or delayed neurotoxicity tests.

    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)