Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

French implementing rules on safety features and anti-tampering device adopted

Eveline Van Keymeulen

On 23 April 2018, Decree No. 2018-291 relating to safety within the medicinal supply chain entered into force. The decree follows a February 2018 information note from the Ministry of Health reminding retail pharmacists and healthcare institutions of their obligations under Commission Delegated Regulation (EU) 2016/161, which further implements the requirement of Directive 2011/62/EU that Read More

FDA announces suite of guidance documents to facilitating development and approval of gene therapies

Daniel Lim

On 22 May 2018, FDA Commissioner Scott Gottleib gave an address at the Annual Board Meeting of the Alliance for Regenerative Medicine.  The wide ranging speech focused on the promise of cell and gene therapies and the challenge that such new technologies present to the existing regulatory frameworks for development and approval. The key takeaways Read More

Commission closes infringement proceedings against Poland, Romania and Slovakia relating to parallel trade of medicines

Juraj Gyarfas

On 17 May 2018, the European Commission announced that it had decided to close its infringement procedures and the treatment of complaints related to parallel trade of medicines for human use against Poland, Romania and Slovakia. By way of background, parallel trade has long been a major concern for both governments and pharmaceutical companies in Read More

Dutch Data Protection Authority clarifies application of GDPR’s right to be forgotten and data portability to medical records

Iradj Nazaryar

The Dutch Data Protection Authority (DPA) recently published information on its website with respect to the application of the right to be forgotten and data portability to medical records under the General Data Protection Regulation ((EU) 2016/679) (GDPR). According to the DPA, the right to data portability applies only to the personal data that the Read More

Belgian Federal Agency for Medicines and Health Products launches new medicines database

Eveline Van Keymeulen

The Federal Agency for Medicines and Health Products recently launched a new medicinal product database containing information on all medicinal products for human and veterinary use authorised in Belgium. This includes medicinal products that have a valid marketing authorisation, registration, authorisation for parallel import or temporary authorisation for use in Belgium. The database includes a Read More