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govardhanpillari ☆ India, 2009-06-20 15:57 (6219 d 17:02 ago) Posting: # 3885 Views: 2,895 |
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Dear All, I have one doubt that, we conducted one BE study five years back for Canada submission, till now, we haven't filed this application. Now we are planning to submit these dosier to Canada regulatory. My doubt is, whether the canada accept this data? what is the maximum time period that Canada should accepts the data after completion of study? Thanks in advance......... Regards PGR — Govardhan.P |
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Helmut ★★★   Vienna, Austria, 2009-06-20 16:13 (6219 d 16:46 ago) @ govardhanpillari Posting: # 3886 Views: 2,380 |
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Dear PGR, I don't see a problem if your study complies with Canadian Guidelines. There's no 'shelf life' for BE-studies (only South Africa mentioned five years in a draft guideline; this requirement was removed in the final version). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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govardhanpillari ☆ India, 2009-06-22 07:52 (6218 d 01:07 ago) @ Helmut Posting: # 3888 Views: 2,279 |
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Dear HS, Thank you very much for your information... Regards, PGR — Govardhan.P |
Ing. Helmut Schütz