Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 95

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 95
---
MP is negative, the applicant is afforded an opportunity to seek a re-examination of the opinion. The CHMP is required to re-examine
its opinion within 60 days following receipt of the request by the applicant. A refusal of a centralized marketing authorization constitutes
a prohibition on placing the given medicinal product on the market in the EU.

The EMA’s Committee for Advanced Therapies (CAT) is responsible
for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMP). ATMP include gene therapy medicinal products,
somatic cell therapy medicinal products and tissue engineered medicinal products. The main responsibility of the CAT is to prepare a draft
opinion on an application for marketing authorization for an ATMP candidate that is submitted to the EMA. The EMA’s Committee for
Medicinal Products for Human Use (CHMP) then provides a final opinion regarding the application for marketing authorization. The European
Commission grants or refuses marketing authorization after the CHMP has delivered its opinion. ATMP are further regulated under Regulation
(EC) No 1394/2007 on advanced therapy medicinal products, as amended on July 26, 2024 and Directive 2001/83/EC on medicinal products
for human use, as amended on January 1, 2025.

National Authorization Procedure

A National Authorization Procedure is used when applying for a
marketing authorization in one individual EEA state. The national procedure can only be used if the medicinal product does not already
have a marketing authorization in another EEA state.

Mutual Recognition Procedure (MRP)

The mutual recognition procedure (Art. 28 Directive 2004/27/EC)
should be used if a medicinal product already has a marketing authorization in one EEA member state, and the authorization holder would
like to extend the authorization to other member states. An application for mutual recognition may be addressed to one or more EEA countries.
The country in which the national marketing authorization has been granted acts as the “ Reference Member State,” and the other
countries concerned (Concerned Member States) can, upon successful completion of the procedure, recognize the marketing authorization.
To this end, the marketing authorization holder shall request the Reference Member State either to prepare an assessment report on the
product or, if necessary, to update any existing assessment report. The assessment time is 180 days plus 30 days.

52

Decentralized Procedure (DCP)

The decentralized procedure (introduced by Directive 2004/27/EU)
is used in