In last week’s blog I discussed how Israel is becoming a clinical trial powerhouse. Earlier this week Fisher Clinical Services participated in the Outsourcing in Clinical Trials Israel Conference. The objective of the conference was to provide attendees with the exclusive opportunity to discuss how they develop their outsourcing strategies & improve operational efficiency in clinical trials to remain cost and time-effective. It certainly achieved its objective as we held many great discussions during the 2 days.
One topic that was of interest was the importation of controlled substances for use in clinical trials in Israel. I would like to share with you some best practice guidelines:
- The local depot would require both an import permit and an import licence from the MOH. In order to acquire this it requires a Proforma Invoice & Form 7 (which is the final site director approval to run a study in the country from one of the participating investigator sites).
- The application for the import permit requires the depot to state the exact quantity of the controlled substance that it being imported. It is essential that the format of the Proforma Invoice either mentions or allows them to calculate the exact quantity of controlled substance.
- The Import permit and Import licence approval process can take up to one month.
- Once the shipment arrives in Israel, all documents will be reviewed by a Ministry of Health (MOH) pharmacist at the airport customs. They have the authority to request additional information.
- The local depot will have special Standard Operating Procedures (SOPs) compliant with local regulations for receipt, storage and distribution of controlled drugs. The drugs are distributed with special forms that require site pharmacist signatures.
- Returns and destructions are handled by the local depot. Accountability is performed on a per tablet/syringe base & destructions are accompanied by a local MOH representative.
For further information on this and/or clinical research in Israel, please do not hesitate to reach out to me at firstname.lastname@example.org