Reply To: IMP Labeling – Israel
February 24, 2023 at 3:23 pmHello,
In my experience, the bare minimum the main IMP label text can be done in is in Hebrew. However, it is a requirement for the “For Clinical Trial Use Only” caution statement to be reflected in four languages; Hebrew, English, Arabic, and Russian. It will be Sponsor’s choice if the desire is to also generate main IMP label text for all four target languages, but again, bare minimum requirement is Hebrew.
If the product is cytotoxic, there is a very specific green label that needs to be applied to signify the product is cytotoxic, your depot network should be able to consult you on this further.
Regarding import license, if my memory serves me right, it’s roughly 2 to 3 weeks. But you’ll need a Form 6 or Form 7 in order to apply for said Import License. A Form 6 enables you to import on a one-time basis to the in-country depot. A Form 7 enables you to import more than one-time and is also needed ahead of each first site shipment (meaning you need a Form 7 for each site in the country). Note that the Form 7 has a 1-year validity period, and it’s very important to track those dates and ensure your project team reapplies promptly.
Hope this helps! 🙂
