Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 100

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 100
---
 and related laws may also give risk to increased risk of private actions, including a new form of class
action that is available under the GDPR.

Israel

Israel Ministry of the Environment — Toxin Permit

In accordance with the Israeli Dangerous Substances Law - 1993,
the Israeli Ministry of the Environment is required to grant a permit in order to use toxic materials. Because we utilize toxic materials
in the course of operation of our laboratories, we were required to apply for a permit to use these materials. Our current toxin permit
will remain in effect until August 2031.

54

Clinical Testing in Israel

In order to conduct clinical testing on humans in Israel, special
authorization must first be obtained from the ethics committee and the head of the medical center in which the clinical studies are planned
to be conducted, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health
Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation. These regulations require
authorization by the institutional ethics committee and the head of the medical center. Israeli Ministry of Health, except for certain
circumstances, is required to approve each trial as well. The institutional ethics committee must, among other things, evaluate the anticipated
benefits that are likely to be derived from the project to determine if it justifies the risks and inconvenience to be inflicted on the
human subjects, and the committee must ensure that adequate protection exists for the rights and safety of the participants as well as
the accuracy of the information gathered in the course of the clinical testing. Since we intend to perform a portion of the clinical studies
on certain of our therapeutic candidates in Israel, we will be required to obtain authorization from the ethics committee and head of
medical center of each institution in which we intend to conduct our clinical trials, and in most cases, from the Israeli Ministry of
Health.

Other Countries

In addition to regulations in the United States, the EU and
Israel, we and our collaborators are subject to numerous and a variety of regulatory requirements of other countries and jurisdictions
regarding quality, safety and efficacy governing, among other things, clinical trials, marketing authorization, manufacturing, commercial
sales and distribution of drugs in other countries. Whether or not our products receive approval from the FDA, approval of such products
must be obtained by the comparable regulatory authorities of countries other than the United States before we or our collaborators can
commence clinical trials, manufacturing or marketing of the product in those countries. The