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chiragkhatri ★ India, 2007-12-27 08:52 (6760 d 01:49 ago) Posting: # 1431 Views: 7,860 |
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Dear Members, Please let me know whether Turkey has their own BA/BE guidelines or they follow others like USFDA or European union. Please provide reference if they use other country guidelines Thanks Chirag Khatri |
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Helmut ★★★   Vienna, Austria, 2007-12-27 14:16 (6759 d 20:26 ago) @ chiragkhatri Posting: # 1432 Views: 7,310 |
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Dear Chirag, the ‘Pharmaceutical General Directorate’ of the Turkish Ministry of Health (MOH) issued the Circular No. B100IEG01000007-BA/BE on 20 January 2006. Unfortunatelly there's no English translation on MOH's website (I could not find it on the Turkish site either). The document is not a guideline, but clarifies shortcomings in submitted dossiers. The requirements listed closely follow the European guideline, with some minor differences. Since I’m on vacation, I will list the main points in a later post; so be a little bit patient…  — 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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chiragkhatri ★ India, 2007-12-28 12:48 (6758 d 21:54 ago) @ Helmut Posting: # 1436 Views: 6,919 |
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Dear Helmut, Thanks, will wait for your reply. Enjoy your vacation and have a wonderful new year. Regards Chirag khatri |
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Helmut ★★★ Vienna, Austria, 2008-01-03 22:38 (6752 d 12:04 ago) @ chiragkhatri Posting: # 1464 Views: 6,928 |
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Dear Chirag, you may download (287kB PDF) the document from our site. Please note that it’s an inofficial translation I’ve got at my workshop in Istanbul in March 2006; I have no idea whether anything has changed in the meantime. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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chiragkhatri ★ India, 2008-01-05 12:50 (6750 d 21:52 ago) @ Helmut Posting: # 1469 Views: 6,805 |
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Dear Helmut, Thanks a lot. Regards Chirag |
Ing. Helmut Schütz