Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 97

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 97
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 act on his behalf in relation to the trial, be established in the EU.

Law Relating to Pediatric Research

Regulation (EC) 1901/2006 (as amended by Regulation (EC) 1902/2006
and Regulation (EU) 2019/5), or the Pediatric Regulation, was adopted on December 12, 2006. This Regulation governs the development of
medicinal products for human use in order to meet the specific therapeutic needs of the pediatric population (children aged 0 to 17 years).
It requires any application for marketing authorization made after July 26, 2008 in respect of a medicinal product not authorized in the
EU on January 26, 2007, the time the Regulation entered into force, to include studies in children conducted in accordance with a pediatric
investigation plan agreed to by the relevant European authorities. This does not apply if the product is subject to an agreed waiver or
deferral or if the product is excluded from the scope of Regulation 1901/2006, which is the case for inter
aliagenerics, homeopathic and traditional (herbal) medicinal products. Waivers can be granted in certain circumstances where pediatric
studies are not required or desirable. Deferrals can be granted in certain circumstances where the initiation or completion of pediatric
studies should be deferred until appropriate studies in adults have been performed. Moreover, this regulation imposes the same obligation
from January 26, 2009 on an applicant seeking approval of a new indication, pharmaceutical form or route of administration for a product
already authorized and still protected by a supplementary protection certificate granted under Regulation (EC) no. 469/2009 or its precursor
Regulation (EEC) 1768/92 by a patent that qualifies for the granting of such a supplementary protection certificate. The pediatric Regulation
1901/2006 also provides, subject to certain conditions, a reward for performing such pediatric studies, regardless of whether the pediatric
results provided resulted in the grant of a pediatric indication. This reward comes in the form of an extension of six months to the supplementary
protection certificate granted in respect of the product, unless the product is subject to Orphan Drug designation, in which case the
10-year market exclusivity period for such orphan products is extended to 12 years. If any of the non-centralized procedures for marketing
authorization have been used, the six-month extension of the supplementary protection certificate is only granted if the medicinal product