Pharma & lifesciences
Pharma & lifesciences
Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating...
Op 12 februari 2018 aanvaardde het hof van beroep te Antwerpen voor de eerste maal (voor zover...
On 28 May, the European Commission adopted the long-awaited Implementing Regulation 2018/775 (‘Implementing Regulation’) laying down...
Following the increasing difficulties with the enforcement of the legislative framework applicable to Food for Special...
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...
What can be concluded from the ruling of the ECJ in Elisabeth Schmitt? The directive does...
Tout en soulignant que la responsabilité du fait d’un dispositif non conforme repose en premier lieu...
Op 1 maart 2017 werd een nieuw koninklijk besluit met betrekking tot geneesmiddelen voor geavanceerde therapie...
