FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional request, data necessary for assessing the safety of the medicinal product. Annex I shall apply by analogy to the particulars and documents specified in point (a).
Maltese: reviżjoni bibljografika ta' l-informazzjoni ta' sigurezza b'rapport espert, u fejn meħtieġ mill-awtorità kompetenti, fuq talba addizzjonali, id-data meħtieġa biex issir stima tas-sigurezza tal-prodott mediċinali. L-Anness I għandu jgħodd b'analoġija għall-partikolaritajiet u d-dokumenti speċifikati fil-punt (a).
English: The requirement to show medicinal use throughout the period of 30 years, referred to in paragraph 1(c), is satisfied even where the marketing of the product has not been based on a specific authorisation. It is likewise satisfied if the number or quantity of ingredients of the medicinal product has been reduced during that period.
Maltese: Il-ħtieġa li jintwera l-użu mediċinali matul il-perjodu sħiħ ta' 30 sena, msemmija fil-paragrafu 1(ċ), tiġi sodisfatta wkoll fejn il-marketing tal-prodott ma kienx ġie bbażat fuq awtorizzazzjoni speċifika. Bl-istess mod tkun sodisfatta jekk in-numru jew il-kwantità ta' ingredjenti tal-prodott mediċinali jkun tnaqqas matul dak il-perjodu.
English: a Community herbal monograph has been established in accordance with Article 16h(3), or (b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.
Maltese: il-prodott mediċinali veġetali jkun jikkonsisti f'sustanzi veġetali, preparazzjonijiet jew kombinazzjonijiet tagħhom li jinsabu fil-lista msemmija fl-Artikolu16f.
English: Article 16g 1.
Maltese: Artikolu 16g 1.
English: They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication.
Maltese: Meta l-Istati Membri jadottaw dawn il-miżuri, għandu jkun fihom referenza għal din id-Direttiva jew għandhom ikunu akkumpanjati b'din ir-referenza fl-okkażjoni tal-pubblikazzjoni uffiċjali tagħhom.
English: the pharmaceutical quality is not satisfactorily demonstrated. 2.
Romanian: calitatea farmaceutică nu este demonstrată în mod satisfăcător.
English: A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question. 3.
Romanian: Un stat membru poate solicita ca eticheta și prospectul însoțitor să precizeze și natura tradiției în cauză.
English: Opinion of the European Parliament of 21 November 2002, Council Common Position of 4 November 2003, Position of the European Parliament of 17 December 2003 (not yet published in the Official Journal) and Council Decision of 11 March 2004.
Lithuanian: 2002 m. lapkričio 21 d. pareikšta Europos Parlamento nuomonė, 2003 m. lapkričio 4 d. Tarybos bendroji pozicija, 2003 m. gruodžio 17 d. Europos Parlamento pozicija (dar nepaskelbta Oficialiajame leidinyje) ir 2004 m. kovo 11 d. Tarybos sprendimas.
English: in Article 1 the following is added: "29.
Slovak: K článku 1 sa pridáva tento text:
Polish: w art. 1 dodaje się następujące punkty:
English: a Community herbal monograph has been established in accordance with Article 16h(3);
Slovak: bola ustanovená monografia spoločenstva o liečivých rastlinách v súlade s článkom 16h ods. 3;
English: prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1);
Slovak: vypracovať návrh zoznamu rastlinných látok, rastlinných prípravkov a ich kombinácií uvedených článku 16f ods. 1;
English: The Member States shall take the necessary measures to comply with this Directive by 30 October 2005. They shall forthwith inform the Commission thereof.
Polish: Państwa Członkowskie podejmują środki niezbędne do wykonania niniejszej dyrektywy do dnia 30 października 2005 r. Niezwłocznie powiadamiają o tym Komisję.