Verzoekschrift
English translation: application form
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| 16:03 Jun 18, 2015 |
| Dutch to English translations [Non-PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Barend van Zadelhoff Netherlands Local time: 20:43 | ||||||
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| Summary of answers provided | ||||
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| 3 +3 | application form for registration |
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| Discussion entries: 2 | |
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Answers
40 mins confidence: 
peer agreement (net): +3
peer agreement (net): +3| verzoekschrift voor het registreren application form for registration Explanation: It seems to me this is an option Examples: Annex 6: Model Application Form for new Marketing Authorizations, Periodic Reviews and Variations, with Notes to the Applicant http://apps.who.int/prequal/info_general/documents/WHO_DMP_R... APPLICATION FORM FOR REGISTRATION AND MARKETING OF A MEDICINE IN THE SADC REGION http://www.ich.org/fileadmin/Public_Web_Site/ABOUT_ICH/Organ... -------------------------------------------------- Note added at 44 mins (2015-06-18 16:48:07 GMT) -------------------------------------------------- APPLICATION FORM FOR REGISTRATION Drug Administration and Control Authority of Ethiopia P.O.Box 5681 Addis Ababa, Ethiopia A. Type of application (check the box applicable) New marketing authorization for a pharmaceutical product http://www.fmhaca.gov.et/documents/Guidlines_for_registratio... -------------------------------------------------- Note added at 53 mins (2015-06-18 16:57:25 GMT) -------------------------------------------------- It is hereby confirmed that all existing data which are relevant to the quality, safety and efficacy of the medicinal product have been supplied in the dossier, as appropriate. The statement above forms part of the standard application form for registration of a drug in Europe and is a legally binding undertaking. It means companies are required to submit positive and negative trials in full to the regulators who will assess benefit and risk before granting a licence. http://www.dailymail.co.uk/news/article-2222220/Drug-firms-r... |
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