Regulatory

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TGA Proposes New Course of Treatment for Software as a Medical Device
In December 2019 the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019...
March 10, 2020
8 min read
Blockchain in the Life Sciences & Healthcare Sectors
Blockchain is perhaps best known as the technology on which Bitcoin and other digital cryptocurrencies...
February 25, 2020
13 min read
Distribution of Free Samples of Medicinal Products to Pharmacists: The Court is requested to settle an Important Issue
The European and national legislations regulate the relationship between healthcare professionals and...
February 11, 2020
4 min read
The US/China Trade Agreement: what could it mean for the Pharma Industry?
Following a long period of negotiation, Phase I of the US-China Trade Agreement was published on 15 January...
February 6, 2020
5 min read
Access to toxicity reports and protection of commercial interests: the Court of Justice of the European Union blows the final whistle!
The Court of Justice of the European Union (CJEU) has recently issued two rulings which aim at ending...
February 4, 2020
8 min read
Bird & Bird: Setting a gold standard in meeting cannabis regulation
Medical Cannabis Network speaks with Bird & Bird’s Ben King and Sally Shorthose about the importance...
January 24, 2020
13 min read
Transfers of value to “influencers”: new disclosure obligation for companies in the health sector
The list of beneficiaries of transfers of value subject to compulsory disclosure in the French public...
January 21, 2020
2 min read
Access to toxicity study reports and protection of commercial interests
Gerard Hogan, Advocate General at the Court of Justice of the European Union (“CJEU”) recently...
November 22, 2019
8 min read
Dutch competition authority ACM publishes a sector report on the impact of biosimilars on competition between TNF-alfa inhibitors
The Dutch competition authority, ACM, initiated a market study in 2018 into the effect of the introduction...
October 7, 2019
5 min read
Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act
The French so-called “anti-gift” provisions strictly frame the conditions under which companies...
July 2, 2019
2 min read