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  1. #1736124

    I gcás ábhar tosaigh a ndearnadh innealtóireacht orthu, beidh san fhaisnéis sin sonraí amhail tuairisc ar na cealla nó na pórtha tosaigh, ar an tslí ina ndéantar an veicteoir léirithe (ainm, áit tionscnaimh, feidhm an veicteora macasamhaileáin agus eilimintí rialtóra eile) a fhorléiriú, an seicheamh DNA nó RNA a bheidh curtha isteach go héifeachtach, ina mbeidh airíonna bitheolaíocha na foirgníochta críochnaithí, airíonna bitheolaíocha an allmhairithe deiridh agus an chobhsaíocht ghéiniteach, arna cur isteach nó arna scriosadh, á chur isteach go héifeachtach.

    For genetically engineered starting materials this information shall include details such as the description of the starting cells or strains, the construction of the expression vector (name, origin, function of the replicon, promoter enhancer and other regulator elements), control of the sequence of DNA or RNA effectively inserted, oligonucleotidic sequences of plasmid vector in cells, plasmid used for cotransfection, added or deleted genes, biological properties of the final construct and the genes expressed, copy number and genetic stability.

    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. #2050011

    I gcás ábhair thosaigh a ndéantar innealtóireacht ghéiniteach orthu, áireofar leis an bhfaisnéis sin sonraí amhail tuairisc ar na cealla nó na pórtha tosaigh, forléiriú ar an veicteoir léirithe (ainm, bunús, feidhm an mhacasamhaileáin, feabhsaitheoir tionscnóra agus eilimintí rialtóra eile), rialú ar an seicheamh DNA nó RNA a chuirtear isteach go héifeachtach, seichimh olaganúicléitíde de veicteoir plasmaide i gcealla, plasmaid a úsáidtear do chomh-thrasfhabhtú, géinte a chuirtear leis nó a bhaintear amach, airíonna bitheolaíocha an fhorléirithe deiridh agus na géinte a léirítear, líon cóipeanna agus cobhsaíocht ghéiniteach.

    For genetically engineered starting materials this information shall include details such as the description of the starting cells or strains, the construction of the expression vector (name, origin, function of the replicon, promoter enhancer and other regulator elements), control of the sequence of DNA or RNA effectively inserted, oligonucleotide sequences of plasmid vector in cells, plasmid used for cotransfection, added or deleted genes, biological properties of the final construct and the genes expressed, copy number and genetic stability.

    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)