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olacy ☆ Hungary, 2012-03-01 12:43 (4838 d 21:55 ago) Posting: # 8196 Views: 3,320 |
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Hi, Could you please advise whether a pivotal study conducted before 2011 (without ISR) can be submitted after Mar 2012 when the new bioanalytical guideline is already effective (and it requires ISR)? Thanks! |
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Ohlbe ★★★ France, 2012-03-01 13:28 (4838 d 21:10 ago) @ olacy Posting: # 8197 Views: 2,812 |
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Dear Olacy, The introduction to Annex I to Directive 2001/83/EC reads: In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) Consequence: what matters is not the date when the trial was performed, but the date when the application is submitted. Submitting now data which do not comply with the guideline (including ISR) has a risk. Regards Ohlbe — Regards Ohlbe |
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olacy ☆ Hungary, 2012-03-01 14:31 (4838 d 20:07 ago) @ Ohlbe Posting: # 8199 Views: 2,753 |
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Thx! |
Ing. Helmut Schütz