Biological Samples in Clinical Trials
This article was originally published in SRA
Executive Summary
New customs regulation introduces monthly import/export licences
New customs regulation introduces monthly import/export licences
The State Customs Committee has issued a regulation on the import and export of human tissues and/or organs, including human blood and its components1. Under the new regulation, which came into effect on 10 November 2002, export and import licences to ship biological samples which are part of clinical trials, issued by the Ministry of Health are valid only for one month from the date of issue. Therefore, currently held permits issued more than a month ago for the whole duration of clinical trials are no longer valid and all official shippers - pharmaceutical companies/contract research organisations - should obtain new permits on a monthly basis from now on.
PYOTR G PLATONOV
References
1. Regulation No 01-06/42926 on the import and export of human tissues and/or organs including human blood and its components to/from Russian Federation, State Customs Committee, 30 October 2002