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Lora Arifagic
I am an associate in the Regulatory, Public & Administrative Law department in our Brussels office.
6
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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – interplay with the Advanced Therapy Medicinal Products (‘ATMP’) Legislation
Legislative process
On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation...
May 8, 2024
6 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal
The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the...
January 18, 2024
7 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – SoHO establishment authorisation
Legislative process
On July 19, 2022, the European Commission introduced a proposal for a regulation...
January 10, 2024
6 min read
Public Procurement for Biological Medicines in Belgium: The Royal Decree of 13 September 2023 opens the door for compulsory tendering when biosimilars enter the market. Can virtue afford to flirt with legality?
Introduction
The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1,...
September 27, 2023
7 min read
Reforming the European pharmaceutical legislation: Shortages of medicinal products
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
August 7, 2023
5 min read
Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework
On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of...
April 28, 2023
3 min read