Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 94

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 94
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. A marketing authorization may either
be granted in a national procedure, or in a coordinated procedure of several member states pursuant to Directive 2001/83/EC, as amended
on January 1, 2025, or under the centralized EU procedure in accordance with Regulation (EC) No. 726/2004, as amended on January 28, 2022.
Depending on the nature of the medicinal product, several different legal frameworks of the EU and the member states may be relevant for
the market clearance.

51

Centralized Procedure (CP)

The Centralized Procedure according to Regulation 726/2004/EC (as
amended on January 28, 2022) allows a marketing authorization holder to market the medicine and make it available to patients and healthcare
professionals throughout the entire EEA on the basis of a single marketing authorization, granted by the European Commission, acting in
its capacity as the European Licensing Authority on the advice of the EMA. The EMA is the administrative body responsible for coordinating
the existing scientific resources available in the member states for evaluation, supervision and pharmacovigilance of medicinal products.

Certain medicinal products (e. g., products derived from biotechnology,
advanced-therapy medicinal products, orphan medicinal products and medicinal products for human use, which contain an active substance
authorized in the European Union after May 20, 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders,
diabetes, auto-immune diseases and other immune dysfunctions or viral diseases) must be authorized centrally. The centralized authorization
procedure is optional for other medicinal products if they contain a new active substance which on May 20, 2002 was not authorized in
the European Union, or if the applicant shows that the medicinal product concerned constitutes a significant therapeutic, scientific or
technical innovation or that the granting of authorization is in the interest of patients in the European Union. For each application
submitted to the EMA for scientific assessment, the EMA is required to ensure that the opinion of the Committee for Medicinal Products
for Human Use, or CHMP, is given within 210 days after receipt of a valid application or within 150 days by means of an accelerated procedure
(excluding clock stops); the review period can be extended. If the opinion is positive, the EMA is required to send the opinion to the
European Commission, which is responsible for preparing the decision granting a marketing authorization. If the initial opinion of the
CH