Authors: Christel Brion, Florence Verhoestraete, Jeroen Boelens en Vincent Wellens (NautaDutilh) Publication date: 19/02/2019 Until recently, certain medical devices could only be distributed in Belgium through limited channels (pharmacies or dental practitioners). In addition, Belgian law prohibited the sale of some medical devices directly to physicians; consequently, patients could obtain such devices only from…
Pharma & lifesciences
Pharma & lifesciences
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Software may be considered medical device – Court of Justice (7 December 2017)
Software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of those provisions, even if that software does not…
Does your clinical trial pass the GDPR test? (Loyens & Loeff)
Author: Stéphanie De Smedt (Loyens & Loeff) Date of publication: 12/10/2018 Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating the processing of health data, international data transfers and contractual arrangements between the parties involved in a clinical trial, the GDPR has had…
If a branded medicine and its generic version are put on the EEA market by economically-linked...
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are...
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced...
On 7 February 2019, the federal government submitted a bill regarding the reimbursement of pharmaceutical specialties...
Until recently, certain medical devices could only be distributed in Belgium through limited channels (pharmacies or...
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that...
Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating...
Software, of which at least one of the functions makes it possible to use patient-specific data...
The discovery of Fipronil residue in chicken eggs due to the use of Fipronil as an...
The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on...
From 19 October 2017, use of the electronic Trade Control and Expert System (“TRACES”) will become...
On 23 June 2017, the Belgian Official Journal contained the Royal Decree of 14 June 2017 implementing the...
On 15 May 2017, the European Commission opened a formal investigation into the pricing of medicines....
On 8 June 2017, the Court of Justice of the European Union (“CJEU”) confirmed that a...
On 22 May 2017, the new Belgian law of 7 May 2017 on clinical trials on...
On 31 May 2017, the European Medicines Agency (EMA) and the European Commission (EC) published the first...
The European Commission’s Regulatory Committee on Medical Devices has adopted a Commission Decision on the qualification...
On 16 May 2017, the General Court handed down its decision in Alfa Wasserman SpA (AW)...
Fakes – whether fake news or fake goods – are currently a popular subject of debate...
On 20 April 2017, the Law on clinical trials with medicines for human use was adopted...
