27 Jun 2022 Luxembourg draft bill on recreational cannabis By David Alexandre Benoîte Chanfray Camille Malécot Following the Luxembourg government's clarifications of October 2021, the Council of Government has recently approved the draft bill on...
27 Jun 2022 FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility By Bethany Hills Hilary Hoffman After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
17 May 2022 Patent term extensions and infringement proceedings in Australia, and the standing of an exclusive licensee By Nicholas Tyacke Alexandra de Zwart Sarah McKenzie For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
05 Apr 2022 The Spanish authorities designate an independent supervisory body to ensure compliance with the clinical trials Code of Conduct. By Elisa Lorenzo After the publication of the Code of conduct regulating the processing of personal data in the field of clinical trials and other...
18 Mar 2022 Clarity and Caution Ahead for Advertisers: Changes to the Australian Therapeutic Goods Advertising Code By Greg Bodulovic Michelle Wang Stephanie Wang After a lengthy industry consultation process by the Australian Therapeutic Goods Administration, the updated Therapeutic Goods...
03 Mar 2022 A new dawn for the UPC and the Unitary Patent By Markus Gampp Sarah Turner In Europe, the unitary patent and the Unified Patent Court (UPC) have moved another step closer since Austria’s deposit of its...
02 Mar 2022 Spain publishes the first code of conduct on the processing of personal data on clinical trials By Elisa Lorenzo Paula Gonzalez de Castejón Llano-Ponte The Spanish Data Protection Commissioner (“AEPD”) has recently approved the “Code of conduct regulating the processing of personal data...
01 Mar 2022 The end of the production chain: Portuguese approach to Cannabis waste management By Mariana Ricardo Ana Rita Santos The Portuguese National Authority for Medicines and Health Products (“INFARMED”) and the Portuguese Environment Agency (“APA”) issued a...
22 Feb 2022 Use of cannabis and derived substances in cosmetics – Portuguese approach By Mariana Ricardo Ana Rita Santos The Portuguese National Authority for Medications and Health Products (INFARMED) issued a bulletin on the topic of the usage of cannabis...
18 Feb 2022 A new chapter in France's CBD legal saga By Marion Abecassis Marion de Galembert In an expected order of 24 January 2022, the interim relief judge of the French Administrative Supreme Court (Conseil d’Etat – “CE”)...
26 Jan 2022 Initiative launched to accelerate EU clinical trials (ACT EU) By Lyndsey Hudson Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical...
25 Jan 2022 Update: DLA Piper Global COVID-19 Vaccine Guide for Employers By Marco de Morpurgo DLA Piper’s Life Sciences team has updated our recent vaccine guide for employers. The changes include significant updates to several...
06 Jan 2022 Portugal: revision to rules on authorisations for growing, trade and distribution of cannabis By Mariana Ricardo Ana Rita Santos Ordinance no. 14/2022, dated 5 January, alters the framework on the authorisation for activities relating to the growing, manufacture,...
11 Nov 2021 The unhealthy healthcare system – a view on the treatment of medical waste By Inês Santana Metello Mariana Ricardo Countries and industries have been progressively setting ‘net zero’ targets, adapting legislation and activities to move towards a...
08 Nov 2021 Poland discusses draft laws to facilitate the cultivation of hemp By Amelia Prawda Andrzej Balicki, Ph.D. On 20 April 2021, the draft bill on hemp ("Draft Bill") was...
03 Nov 2021 New draft law initiatives to tackle medical waste in Romania By Amalia Musat On 11 October 2021, the Senate of Romania adopted the following initiatives to tackle medical waste in Romania.(i) Draft Law on the...