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Posts with tag regulatory

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Renewal of early access and compassionate use frameworks in France
On 1 July 2021, the early access and compassionate use reform entered into force. A medical treatment is generally only available to patients after being granted a market authorisation (“MA”). However, certain conditions call for a medicinal product not yet approved. In recent years, different derogatory procedures have been designed and implemented in France to give patients who are suffering from rare, serious or disabling conditions access to medicinal product where there is no...
November 10, 2021
6 min read
UK medical devices regime set for an upgrade
Just 7 months after the expiry of the Brexit transition period,...
October 7, 2021
4 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns...
Operation Pangea is a yearly recurring operation in which Interpol...
June 24, 2021
2 min read
EU merger control – new guidance brings uncertainty...
Illumina’s acquisition of cancer testing startup, Grail, looks...
April 20, 2021
7 min read
Introduction of the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021
On the 3rd February 2021, the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 (Bill) was introduced...
March 2, 2021
1 min read
Impact of Brexit on Artificial Intelligence in Healthcare
AI developments in the UK The UK is starting to uncover significant opportunities...
February 5, 2021
5 min read
Hungary: New Legal Provisions set out Mandatory Infrastructure for Telemedicine
Until recently the Hungarian legal background of telemedicine was not particularly detailed. For obvious...
September 29, 2020
4 min read
Post-Transition Brexit: New MHRA Guidelines on Medical Devices
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 21, 2020
4 min read
Transfer of value in France: publication of the regulatory provisions specifying the ceilings above which an authorization from the authorities is required
An important change to the new regime governing transfer of value to HCPs, students and associations...
August 20, 2020
2 min read
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