On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application. The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells. These sets of rules govern the sourcing and
On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not…
In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions. This is the case even where the CBD is derived from the whole cannabis plant. The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union. This is likely to have wide implications for the CBD industry.
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On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable…
France has enacted new rules on the off-label use of medicines. A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”). This Decree follows the adoption of the amended social security budget bill in August last year, which introduced revisions to the preexisting Article L5121-12-1 PHC. According to the legislative history of the law, this change may have been intended to allow off-label prescription of Roche’s cancer drug Avastin® after reformulation to treat the eye condition age-related macular degeneration, instead of the Novartis product Lucentis®, which is specifically developed and approved for that indication.
Continue Reading New French Rules On Off-Label Use