Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 201

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 4
Chunk 201
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 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.
Decentralized Procedure (DCP)
 
The decentralized procedure (introduced by Directive 2004/27/EU) is used in 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