Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 98

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 98
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is authorized in all member states. Where the product is no longer covered by a patent or supplementary protection certificate, the applicant
may make a separate application for a Pediatric Use Marketing Authorization, or PUMA, which, on approval, will provide eight years’
protection for data and 10 years’ marketing protection for the pediatric results.

53

Post-authorization Obligations

An authorization to market a medicinal product in the EU carries
with it an obligation to comply with many post-authorization regulations relating to the marketing and other activities of authorization
holders. These may include requirements relating to provision of a risk management plan and provision of annual periodic safety update
reports, carrying out of post-authorization efficacy studies and/or post-authorization safety studies, maintenance of a pharmacovigilance
system master file, adverse event reporting, signal detection and management and other pharmacovigilance activities conducted under an
established quality system, advertising, packaging and labelling, patient package leaflets, and distribution. The regulations frequently
operate within a criminal law framework, and failure to comply with the requirements may not only affect the authorization, but also can
lead to financial and other sanctions levied on the company in question and responsible officers. EU pharmacovigilance legislation has
been significantly modified by the Pharmacovigilance Directive, Directive 2010/84/EU (as amended on January 20, 2011) which amended the
legal framework of pharmacovigilance for medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect to EU authorized
medicinal products and in Directive 2001/83/EC with respect to nationally authorized medicinal products (including those authorized through
the mutual recognition and decentralized systems). Furthermore, EU good pharmacovigilance practice (GVP) rules apply. With the amended
pharmacovigilance requirements, the financial and organizational burden on market authorization holders increased significantly, such
as the obligation to maintain a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in
accordance with Directive 2001/83/EC (as amended on January 1, 2025) or Regulation (EC) No 726/2004 (as amended on January 28, 2022).
Marketing authorization holders must furthermore collect data on adverse events associated with use of the authorized product outside
the scope of the authorization. Pharmacovigilance for biological products and