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Reply To: Russia Country Specific Import LicenseFebruary 26, 2020 at 8:33 am
yes I had this kind of inquiry from them. I do not know if this was the case for everybody, but Russia was really restrictive for us on only releasing an umbrella import license for the quantities that could be justifiable by the protocol – .i.e. if you will have 10 patients and for each you would dispense 10 IMPs during the course of the study you could have an import license for 100 IMPs. – This was the main info we were providing.
On top of that, in order to get a higher amount on the IL, it was created a letter from sponsor side explaining that the products are temperature controlled, they should be kept at 2 to 8 and therefore additional quantities would be required urgently in case of temperature excursions and do not jeopardize patients or the study itself – This was a justification to ask X% on top of the previous calculation.
On our case, the CRO was the one to request the import license, there was a refusal to send the letter with the explanation mentioning this would never work. Lucky of us, we overruled them and it worked already for 5 different cases.
I hopes this answers your question