Iron Swords -
Healthcare and Life Sciences Regulatory Updates

The Israeli Ministry of Health (the “MOH”), has recently issued guidelines, intending to address the current situation in Israel, also known as the “Iron Swords War”.
The following are two major guidelines that are relevant to the international healthcare industry that operates in Israel:

(1)    Inventory Requirements for Medical Preparations and Raw Materials
On October 24, 2023, the MOH issued a notice addressed to holders of preparations’ registration (the “Registration Holders”) and importers of raw materials (the “Importers”). The MOH reminds the Registration Holders and Importers of the MOH’s requirement (issued per the regulations promulgated under the Pharmacists Ordinance, 1981) to maintain a 1-month equivalent of inventory, which should be available for marketing (rather than inventory that is already sold or held for a specific medical institution). Registration Holders and Importers are requested to monitor their existing inventory, to ensure the ongoing supply of medical preparations for the Israeli market.

In the event a Registration Holder or an Importer is not in compliance with the above inventory-related requirement or is unable to meet this requirement within 7 days, such Registration Holder or Importer, as applicable, is required to issue notifications regarding such shortages, in accordance with the MOH’s applicable procedures, all in order to allow medical institutions to prepare for such shortages.

(2)    Performance of Clinical Trials
On October 11, 2023, the MOH issued a notice, addressed to pharmaceutical companies, clinical trial sponsors, medical institutions’ managers, and institutional Helsinki Committees, regarding the performance of clinical trials in these times of emergency. Pursuant to such notice, despite the massive workload of medical institutions in Israel, medical institutions should make efforts to ensure that participants in ongoing clinical trials receive the required medical treatment.

The MOH reminds those involved in the field of clinical trials, that the pilot guidelines previously issued during Covid-19 pandemic, are still in effect. These guidelines allow, among others, for the delivery of the investigational products directly to the participants’ homes, to allow smooth continuation of active clinical trials. See our previous legal update on the matter here.
The content in this communication is provided for informational purposes only and is not intended to be comprehensive. It does not serve to replace professional legal advice required on a case by case basis.
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