FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Unexpected, non-serious, suspected adverse reactions which, according to the assessment carried out by the holder of the marketing authorization, can be attributed to the medicinal product and requiring a change to the summary of products characteristics referred to in Article 4 (9) second paragraph of Council Directive 65/65/EEC (2), as last amended by Directive 93/39/EEC (3), and in Article 5 (9) second paragraph of Council Directive 81/851/EEC (4), as last amended by Directive 93/40/EEC, shall be dealt with in accordance with Commission Regulation (EC) No 542/95 of 10 March 1995, as last amended by Directive 93/40/EEC (5), concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (6), and with Commission Regulation (EEC) No 541/95 of 10 5a7 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State (7).
Lithuanian: Kilus nenumatytoms, nepavojingoms, įtariamoms ir nepageidaujamoms reakcijoms, kurių priežastis, remiantis leidimo prekiauti savininko atliktu vertinimu, gali būti vaistas, ir dėl kurių turi būti padarytas pakeitimas produkto apibūdinimo santraukoje, nurodytoje Tarybos direktyvos 65/65/EEB[2] su paskutiniais pakeitimais, padarytais Direktyva 93/39/EEB[3], 4 straipsnio 9 dalies antroje pastraipoje, ir Tarybos direktyvos 81/851/EEB[4] su paskutiniais pakeitimais, padarytais Direktyva 93/40/EEB, 5 straipsnio 9 dalies antroje pastraipoje, į jas reaguojama pagal 1995 m. kovo 10 d. Komisijos reglamentą (EB) Nr. 542/95 su paskutiniais pakeitimais, padarytais Direktyva 93/40/EEB[5], dėl leidimo prekiauti, kuriam taikomas Tarybos reglamentas (EEB) Nr. 2309/93, sąlygų pakeitimo nagrinėjimo[6], ir 1995 m. kovo 10 d. Komisijos reg lamentą (EEB) Nr. 541/95 dėl leidimo prekiauti, išduoto valstybės narės kompetentingos institucijos, sąlygų pakeitimo nagrinėjimo[7].
English: See page 15 of this Official Journal.
French: Voir page 15 du présent Journal officiel.
Portuguese: Ver página 15 do presente Jornal Oficial.
Hungarian: 6 Lásd ennek a Hivatalos Lapnak a 15. oldalát.
Romanian: A se vedea pagina 15 din prezentul Jurnal Oficial.
Maltese: Ara l-paġna 15 ta' dan il-Ġurnal Uffiċjali.
English: See page 7 of this Official Journal.
French: Voir page 7 du présent Journal officiel.
Portuguese: Ver página 7 do presente Jornal Oficial.
Hungarian: 7 Lásd ennek a Hivatalos Lapnak a 7. oldalát.
Romanian: A se vedea pagina 7 din prezentul Jurnal Oficial.
Maltese: Ara l-paġna 7 ta' dan il-Ġurnal Uffiċjali.
English: Unexpected, non-serious, suspected adverse reactions which, according to the assessment carried out by the holder of the marketing authorization, can be attributed to the medicinal product and requiring a change to the summary of products characteristics referred to in Article 4 (9) second paragraph of Council Directive 65/65/EEC (2), as last amended by Directive 93/39/EEC (3), and in Article 5 (9) second paragraph of Council Directive 81/851/EEC (4), as last amended by Directive 93/40/EEC, shall be dealt with in accordance with Commission Regulation (EC) No 542/95 of 10 March 1995, as last amended by Directive 93/40/EEC (5), concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (6), and with Commission Regulation (EEC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State
Bulgarian: Предположенията за неочаквани и нежелани леки ефекти, които могат да бъдат приписани на лекарствения продукт според оценката, направена от притежателя на разрешителното за пускане на пазара и които налагат промяна в резюмето на характеристиките на продукта, визирано в член 4, параграф 2, точка 9 от Директива 65/65/ЕИО на Съвета , последно изменена и допълнена с Директива 93/39/ЕИО , и в член 5, параграф 2, точка 9 от Директива 81/851/ЕИО на Съвета , последно изменена и допълнена с Директива 93/40/ЕИО , се разглеждат в съответствие с Регламент (ЕО) № 542/95 на Комисията от 10 март 1995 г. за прегледа на промените в условията на разрешителните за пускане на пазара, произтичащ от Регламент (ЕИО) № 2309/93 на Съвета , и в съответствие с Регламент (ЕО) № 541/95 на Комисията от 10 март 1995 г. за прегледа на промените в условията на разрешителните за пускане на пазара, издадени от компетентните органи на държавите-членки .