Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #664573

    IATE #3592276
    bosca rochtana Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás ina ndéanfar tagairt do dheimhniú oiriúnachta, tabharfaidh an monaróir dearbhú i scríbhinn don iarratasóir nár athraíodh an modh monaraíochta ó dheonaigh an Stiúrthóireacht Eorpach um Cháilíocht Leigheasra agus Cúraim Sláinte an deimhniú oiriúnachta. I gcás ina gcomhlánaítear agus ina sínítear an réimse “bosca rochtana” sa deimhniú, measfar go mbeidh an ceanglas sin comhlíonta gan gá a bheith ann le dearbhú breise.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    box of access
    en
    Definition "box of a copy of a certificate of suitability which must be signed if the manufacturer has given an assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines and HealthCare" Reference "COM-IT based on: - Commission delegated regulation (EU) …/... amending Annex II to Regulation (EC) No 2019/6 of the European Parliament and of the Council (13.1.2021)- Council of Europe. EDQM. Certification of Substances Division, Certification of suitability to the Monographs of the European Pharmacopoeia. Guideline on requirements for revision/renewal of certificates of suitability to the European pharmacopoeia monographs (13.1.2021)"