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vish14184 ★ India, 2008-06-04 15:20 (6600 d 13:47 ago) Posting: # 1914 Views: 5,817 |
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Dear All, IS it necessary to obtain T-licence for Pilot BA/BE study? IS there any reference regarding T-licence? Thank you Regards Vishal Nakrani |
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Jaime_R ★★ Barcelona, 2008-06-04 16:45 (6600 d 12:21 ago) @ vish14184 Posting: # 1917 Views: 5,247 |
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Dear Vishal! ❝ IS there any reference regarding T-licence? I don't know this term; is it an abbreviation for 'Trial-licence'? In the EU you have to apply for all clinical studies (term: CTA - clinical trial application). The procedure is based on Directive 2001/20/EC and followings (on GMP, IMPDs,...). See the guidance page for details. ❝ IS it necessary to obtain T-licence for Pilot BA/BE study? Whatever a 'T-license' is: a pilot BA/BE study is a clinical study - therefore the same rules apply. — Regards, Jaime |
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vish14184 ★ India, 2008-06-05 10:10 (6599 d 18:56 ago) @ Jaime_R Posting: # 1922 Views: 5,044 |
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Dear Sir, T-licence means Test-Licence. Which required for import of IP for conduct of clinical trial in India. Regards Vishal Nakrani -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Jaime_R ★★ Barcelona, 2008-06-05 13:40 (6599 d 15:26 ago) @ vish14184 Posting: # 1924 Views: 5,084 |
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Dear Vishal! ❝ [...] Test-Licence required for import of IP for conduct ❝ of clinical trial in India. Interesting, I did not know this term - it's not mentioned in Schedule Y and it's appendices. Do you have a reference? According to Schedule Y I don't see a difference between a pilot study and a main study in BE - both are clinical studies. — Regards, Jaime |
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drshiv ★ India, 2008-07-04 12:05 (6570 d 17:02 ago) @ Jaime_R Posting: # 1996 Views: 5,599 |
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Dear All, T-License is necessary to obtain for those drugs which are introduced in India within 4 years. For those drugs older than 4 years T-License is not required. But Ethics Committee permission is a must. If for those drugs older than 4 years in India need to be imported then you need to apply for T-License. This license comes along with the permission to conduct BA/BE or clinical trial. This application to be done using Form 12 as per Schedule Y. |
Ing. Helmut Schütz