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Lora Arifagic
Lora Arifagic
I am an associate in the Regulatory, Public & Administrative Law department in our Brussels office.
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General
Marc Martens
Marc Martens
 Lora Arifagic
Lora Arifagic
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 General
Marc Martens
Marc Martens
 Lora Arifagic
Lora Arifagic
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 Pharmaceuticals
Lora Arifagic
Lora Arifagic
 Marc Martens
Marc Martens
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
medicinal products Pharmaceuticals
Lora Arifagic
Lora Arifagic
 Sarah Faircliffe
Sarah Faircliffe
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
Pharmaceuticals
Marc Martens
Marc Martens
 Lora Arifagic
Lora Arifagic
 Kevin Munungu
Kevin Munungu
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