Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 96

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 96
---
 cases where the medicinal product has not received a marketing authorization in the EU at the time of application. It allows
the common assessment of an application submitted simultaneously to several member states. One of the member states will take the lead
in evaluating the application as Reference Member State to facilitate agreement with the Concerned Member States and the grant of a national
marketing authorization in all of these member states. To this end, the Reference Member State conducts a detailed review and prepares
a draft assessment report, a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package
leaflet and shall send these documents to the Concerned Member States to provide comments. The assessment time is 210 days plus 30 days.

Manufacturing Requirements

Any medicinal product placed on the market in the EEA must be manufactured
in accordance with the principles of good manufacturing practice as set out in Directive EC2017/1572 supplementing Directive 2001/83/EC
of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products
for human use for human use and Volume 4 of the “ Rules Governing Medicinal Products in the European Community”. Directive
2017/1572/EU has replaced Directive 2003/94/EC. Directive 2003/94/EC will still be applicable to clinical trials conducted in accordance
with the former regime under transitional provisions. Furthermore, distribution of medicinal products in the EU is subject to Directive
2001/83/EC and current guidance on good distribution practice, or GDP. Moreover, EU law requires the clinical results in support of clinical
safety and efficacy to be based upon clinical trials conducted in the EU in compliance with the requirements of the CTR and Directive
2005/28/EC, which implement good clinical practice in the conduct of clinical trials on medicinal products for human use. Clinical trials
conducted outside the EU and used to support applications for marketing within the EU must have been conducted in a way consistent with
the principles set out in the CTR or if conducted prior to 31 January 2022, its predecessor Directive 2001/20/EC. The conduct of a clinical
trial in the EU requires, pursuant to the CTR, authorization by the relevant national competent authority where a trial takes place, and
an ethics committee to have issued a favorable opinion in relation to the arrangements for the trial. It also requires that the sponsor
of the trial, or a person authorized to