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RegisterC of A [GxP / QC / QA]
Dear Ohlbe
You are right, you can not run a study in Germany with a non-EU product, without a release by a QP etc. You need a CTA, IMPD and so on. But as far as I understand we are not talking about a clinical study. The investigator treats the volunteers with a registered drug in order to get plasma samples. You can not call this clinical use but it is also no clinical study, something in between. IMHO if you want to do it correctly you have to submit a CTA including IMPD and I guess nobody would spent such effort and costs (I know it is done illegally without any protocol or ethics vote, just administer the drug to one or two volunteers, draw some blood samples and nobody cares).
Regards
Dan
You are right, you can not run a study in Germany with a non-EU product, without a release by a QP etc. You need a CTA, IMPD and so on. But as far as I understand we are not talking about a clinical study. The investigator treats the volunteers with a registered drug in order to get plasma samples. You can not call this clinical use but it is also no clinical study, something in between. IMHO if you want to do it correctly you have to submit a CTA including IMPD and I guess nobody would spent such effort and costs (I know it is done illegally without any protocol or ethics vote, just administer the drug to one or two volunteers, draw some blood samples and nobody cares).
Regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
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