Eveline Van Keymeulen
Counsel – Paris
Tel +33140065566
eveline.vankeymeulen@allenovery.com
Editor-in-chief
Eveline heads Allen & Overy’s Life Sciences Regulatory practice.
Her practice focuses on EU Life Sciences regulatory law, and she has in-depth expertise in national regulations in France, Belgium and the Netherlands. She advises multinational clients, in the pharmaceutical and medical devices sector, on a broad range of regulatory issues, including clinical trials, marketing authorisations and CE marking, advertising and promotion, product life cycle management, and pricing and reimbursement.
Eveline is an active speaker and writer on Life Sciences topics, and serves as editor-in-chief of the A&O Life Sciences Hub. She is Associate Editor of the European Pharmaceutical Law Review and country correspondent for the Bio-Science Law Review.
Eveline has been named as a “Next Generation Lawyer” by Legal 500 for Life Sciences (in 2018) and recognised by Who’s Who Legal Life Sciences as one of the leading lawyers for Life Sciences: Regulatory (in 2016, 2017, and 2018). Clients say that Eveline is “excellent” and “very good and always a pleasure to work with.”
Eveline received her law degree from Ghent University and holds an LL.M. from the University of California, Berkeley, as well as a Master in European Law from Ghent University and a Master in Intellectual Property Law from Brussels University. She is admitted to the Brussels, Paris and New York bar.
Posts by: Eveline Van Keymeulen
- New measures on advertising and information of health products take effect in France
- French Senate issues recommendations to tackle pharmaceutical supply disruptions
- French regulator (ANSM) introduces fast-track authorisation procedures for clinical trials
- Belgium: Mobile health apps can now be published on mhealthbelgium.be
- French antitrust watchdog launches public consultation regarding distribution of OTC medicines
- French report on improving access to drug information published
- Telemedicine becomes a reality in France
- French ATU procedure simplified to ensure rapid patient access to innovations
- New directive on GMP transposed into Belgian law
- France publishes call for projects on incentive mechanisms to favour hospital prescription of biosimilars
- Getting ready for the EU MDR: New guidance documents available for manufacturers
- Getting ready for the EU MDR: Requirements for identification and traceability of medical devices
- French data protection authority (CNIL) publishes reference methods for health data processing
- French government meets with healthcare industry at eighth meeting of the Strategic Council for the Healthcare Industries
- European Medicines Agency suspends clinical data publication
- French Administrative Supreme Court quashes mandatory certification of medical prescription assistance software
- Brexit White Paper: UK’s proposals on future relationship with EU acknowledge the needs of the Life Sciences industries
- Rewarding innovation: pharmaceutical incentives as a crucial instrument to foster public health
- Getting ready for the EU MDR: New obligations for Notified Bodies
- France debates measures to facilitate early access to medicines
- Getting ready for the EU MDR: Obligations for economic operators
- Brexit and the medical devices industry: coping with uncertainty
- ANSM clarifies that it does not recommend "neutral packaging" of medicinal products in the midst of pharma industry criticism
- European Commission adopts revised definition of “similar medicinal product”
- European Commission proposes export manufacturing waiver for SPCs
- French implementing rules on safety features and anti-tampering device adopted
- Belgian Federal Agency for Medicines and Health Products launches new medicines database
- France publishes list of low-interventional and non-interventional human clinical trials
- French Administrative Supreme Court paves way for advertising non-prescription medicines on pharmacy websites
- Belgian regulator amends guidelines on labelling and packaging of human medicines
- Revised Dutch policy rules on inducement prohibition regarding medicinal products enter into force
- Getting ready for the EU MDR: Classification of medical devices
- Belgium adopts new Royal Decree on biobanks
- Getting ready for the EU MDR: Timelines for manufacturers
- Belgium to strengthen role of e-health apps in patient healthcare
- ANSM recommendations prohibit use of umbrella brands with respect to health products in France
- ANSM publishes recommendations on the labelling and packaging of oral medicinal products
- EMA Transparency Policy upheld by General Court: companies unable to show that submissions to EMA are confidential
- CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?
- EU General Court rules on transparency of clinical trial data
- France issues guidance on reporting non-compliant prescribing or use of medicinal products
- Belgium: Digital platform for medical files to be launched
- Medical devices: European Commission updates Manual on Borderline Products
- Belgium: New proposal to cease reimbursement of costly medicinal products after patent expiry
- French court confirms that pharmacists can sell non-prescription medicinal products on Doctipharma e-platform
- France: ANSM publishes Q&A for medical device manufacturers in case of notified body denotification
- Belgian Royal Decree on clinical trials adopted
- European Commission publishes roadmap for its joint evaluation of the Orphan and Paediatric Medicines Regulations
- Brexit: EMA’s regulatory guidance on centrally approved medicinal products – the present state of play
- France sets up committee to combat cyber-attacks on medical device software
- Belgium: Stricter checks on price-setting of medicinal products
- France one step closer to biosimilar substitution: ANSM introduces first similar biologic groups
- Dutch guidance on inducements by medical devices companies published
- BeNeLuxA collaboration moves forward with launch of e-platform and two additional pilot projects
- Belgian Royal Decree on controlled substances facilitates enforcement of synthetic drugs
- French regulators provide guidance to prevent confusion between medicines and food supplements
- Ethical health platform Mdeon designated as organisation to handle disclosure under Belgian Sunshine Act
- Regulating CRISPR genome editing in humans: where do we go from here?
- ANSM launches public consultation on advertising of medicinal products to public
- EMA ensures business continuity while preparing for Brexit
- Majority of invented names for medicinal products rejected
- France envisages joining BeNeLuxA initiative
- BeneluxA collaboration joint pricing negotiations fail
- ANSM publishes results of French pilot project on new EU clinical trials procedures
- New circular clarifies revised French transparency requirements
- Belgian Sunshine Act enters into force
- Belgian betransparent.be platform publishes 2016 results
- Belgium: FAMHP issues guidance for clinical trial pilot project
- France further clarifies scope of clinical trial rules
- New requirements for Temporary Authorisations for Use in France
- European Commission & EMA publish regulatory guidance for pharmaceutical companies post-Brexit
- National System of Health Data increases access to health data in France
- Agnès Buzyn appointed as French Minister of Health
- Proposal on Horizon Scanning for pharmaceuticals for the BeNeLuxA collaboration published
- French HAS publishes revised certification standard for promotional activities involving healthcare professionals
- Belgium's absolute advertising prohibition for oral and dental care services incompatible with EU law
- Dutch legal framework on favouritism for the medical devices sector near
- EU medical device regulations published today – entry into force 25 May 2017
- Belgium adopts law to prepare for Clinical Trials Regulation implementation
- EMA issues revised guidance on the publication of clinical data on medicinal products for human use
- Revised French transparency regime enters into force
- Dutch court prohibits disclosure of information by Medicines Evaluation Board
- Belgian multiannual framework agreement to streamline delivery of medicines
- OECD launches online consultation on sustainable access to innovative therapies
- EMA and HMA set up big data task force to establish roadmap on the use of big data in medicines assessment
- EMA calls for data protection experts to further implement transparency policy
- European Commission publishes long-awaited study on off-label use: industry reacts
- French Administrative Supreme Court upholds Avastin Temporary Recommendations for Use
- Belgian Chamber of Representatives approves new innovation income system
- ANSM publishes the first year of results in the French pilot project on new EU clinical trials procedures
- France adopts stricter "anti-gift" provisions to limit conflicts of interest
- The Netherlands puts itself forward as a candidate for future EMA location
- The Belgian Sunshine Act: what's in a name?
- Reinforced transparency and budget provisions in place for Belgian healthcare sector
- Agreements between life sciences companies and healthcare actors subject to stricter transparency requirements
- French Parliament approves expanding substitution of biosimilars
- New requirement to provide ANSM with summary of characteristics for medical devices
- Belgium: 24 pilot projects for mobile health apps to be implemented in 2017
- Biomonitoring competence transferred from French ANSM to Biomedicine Agency
- Online sales of medicines take a step forward in France
- New Decree fine tunes French Shared Medical Records system
- France advances towards alignment with EU Clinical Trial Regulation
- Belgian Medicines Agency backs up EU awareness campaign on side effects of medicines
- Belgium launches public consultation on clinical trial involving genetically modified medicine
- French General Directorate for Health sets priorities for 2017-2019
- French Ministry of Health launches awareness campaign to boost consumption of generic medicines
- ANSM opens public consultation with respect to its draft recommendations on medicinal product names
- France: Long-awaited biosimilar register created
- France's Shared Medical Record takes shape
- French Administrative Supreme Court rejects requests for annulment of Decree on Temporary Recommendations for Use
- Belgian transparency register goes live
- France aligns clinical trial rules with EU Clinical Trial Regulation
- Proposed publication policy for Dutch regulators foresees proactive disclosure of inspection data
- French Minister of Health issues action plan to strengthen the safety of clinical trial volunteers
- ANSM relaxes its position on interchangeability of biosimilars
- French Competition Authority issues unfavourable opinion on draft decrees regulating online sales of medicines
- ANSM issues measures regarding first-in-human trials in wake of French trial tragedy