SOCIAL QUESTIONS|health|pharmaceutical industry
- staidéar sábháilteachta iar-údarúcháin neamh-idirghabhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Maidir le staidéir shábháilteachta iar-údarúcháin neamh-idirghabhálacha a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine ar táirgí iad atá údaraithe i gcomhréir leis an Rialachán seo agus a chomhlíonann ceann de na ceanglais dá dtagraítear in Airteagal 10 agus in Airteagal 10a den Rialachán seo, beidh feidhm ag an nós imeachta dá bhforáiltear i mír 3 go mír 7 d’Airteagal 107m, in Airteagal 107n go hAirteagal 107p agus in Airteagal 107q (1) de Threoir 2001/83/CE.' Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
- non-interventional post-authorisation safety study | non-interventional PASS
- en
- Definition safety studies of authorised products that are not clinical trials and that involve collection of data from patients and health care professionals, thus falling outside the scope of Directive 2001/20/EC (Clinical Trials Directive) Reference "COM-EN based on: Sabine Straus, Stella Blackburn. EC Implementing Measure The format of protocols, abstracts and final study reports for the non-interventional post- authorisation safety studies. European Medicines Agency http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/04/WC500105324.pdf [29.3.2012]& Proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:52008PC0665/EN & Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Text with EEA relevance, CELEX:32010L0084/EN"
- Comment "See also: post-authorisation safety study [ IATE:2251252 ] and non-interventional trial [ IATE:1270043 ]. A post-authorisation safety study is non-interventional if the following requirements are cumulatively fulfilled:- the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation; - the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study; and- no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.Reference: 'Guideline on good pharmacovigilance practices (GVP): Module VIII – Post-authorisation safety studies'. European Medicines Agency; 2012, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123204.pdf [20.4.2012]"
- étude de sécurité post-autorisation non interventionnelle
- fr
- Definition étude de sécurité de médicaments autorisés qui ne sont pas des essais cliniques, dans le cadre de laquelle le ou les médicaments sont prescrits de la manière habituelle conformément aux conditions fixées dans l'autorisation de mise sur le marché Reference "TERM-FR, d'après notamment:Directive 2001/20/CE du Parlement européen et du Conseil du 4 avril 2001 concernant le rapprochement des dispositions législatives, réglementaires et administratives des États membres relatives à l'application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain, CELEX:32001L0020/FR & Proposition de directive du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituantun code communautaire relatif aux médicaments à usage humain, CELEX:52008PC0665/FR"