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
- French anti-gift regulation is now complete!
- France: Extension of framework agreement between French Pharmaceutical Companies Association and Economic Committee for Health Products
- Covid-19 – Coronavirus: French Health Ministry publishes orders and decrees concerning serological tests assessments, listings and reimbursements
- Decree on French anti-gift regulation published
- France: Free samples of medicinal products only available on prescription must not be distributed by pharmaceutical companies
- France - Update of national early meetings guide for medicines evaluation
- Covid-19 coronavirus: French High Health Authority publishes position on the use of rapid serological tests
- Start of French medical cannabis pilot programme postponed to January 2021
- Advocate General of the CJEU considers French ban on hemp-derived cannabidiol (CBD) contrary to EU law
- Covid-19 coronavirus: Update on and processes of the clinical trials on Covid-19 patients in France
- Simplification of registration procedure for French person responsible for pharmacovigilance
- On-going debate on new French Bill regarding online sale of medicines
- French ANSM establishes accelerated procedures for Covid-19 treatments and issues FAQ for on-going clinical trials
- BREAKING: Commission seeks to postpone implementation of EU Medical Device Regulation in light of Covid-19 crisis
- French Administrative Supreme Court annuls CEPS decision for market exclusivity reasons
- Amendment of Belgian legislation on medicines shortages
- France takes concrete actions to ensure continued supply and good use of health products in the context of Covid-19
- EU takes measures to regulate distribution of medical supplies in response to Covid-19
- France clarifies situations in which physicians and pharmacists can exclude generic substitution
- France – Law on fighting waste and the circular economy finally enacted
- Belgium - FAMHP issues new authorisation form for parallel import of medicines
- French guidance on marketing limitations for food products
- French Constitutional Council censors National Assembly’s ‘historic’ amendment on transparency
- French Administrative Supreme Court annuls marketing authorisation for procedural reasons
- The UK Food Standards Agency sets deadline for the CBD industry and provides safety advice to consumers
- Belgium - FAMHP issues updated guidance document for clinical trial sponsors
- France - Impact of the 2020 Social Security Financing Bill for life sciences companies
- French medical cannabis programme: CSST provides further guidance and statement of works to be published in February
- French Court of Auditors publishes report on National Professional Order of Physicians
- Belgium - PharmaStatus: new online platform on availability of medicines
- France defines medical situations in which physicians can exclude generic substitution
- France: Details of hybrid groups register published
- French Health data hub officially created
- French Administrative Supreme Court paves way for medical practitioner advertising
- Europe: Medical Devices Coordination Group issues guidance on the classification of software as a medical device
- France: Draft 2020 Social Security Financing Bill encourages price cuts and biosimilar uptake
- French ANSM decides to maintain fast-track procedures for clinical trials
- French pharmaceutical industry association denounces recent study on influence of gifts on prescribing practices
- France: Industry calls for moratorium on price cuts
- Belgian Constitutional Court overrules sales restriction for wholesale distributors of medicines
- French Administrative Supreme Court rejects AFIPA's appeal in relation to ANSM recommendations
- First phase of French medical cannabis pilot programme officially started
- Amendment to Social Security Financing Bill seeks to provide clear legal basis for French medical cannabis pilot programme
- The Nagoya Protocol five years into play: key points of attention when working with genetic resources
- French government determined to sanction pharmaceutical companies for shortages of medicines
- France: Innovative medicines marketed too slowly
- Belgian Constitutional Court suspends sales restriction for wholesale distributors of medicines
- France: Modification and simplification of the reimbursement evaluation procedure for certain medicinal products
- France: Enactment of new health law
- Belgium introduces “linked” reimbursement procedure for personalised medicines and companion diagnostics
- French “Pilot phase” for the clinical investigation on medical devices
- Big day for legal cannabis in France: ANSM endorses medical cannabis pilot and launch of cannabis Parliamentary Mission
- Belgium: New developments point at possibly imminent changes in (online) pharmacy market
- French cannabis committee unveils recommendations for medical cannabis pilot programme in France
- French Supreme Court confirms monopoly of pharmacists for online sale of medicines
- Italy launches urgent tender for the supply of 400 kg of medical cannabis: New opportunities for cannabis producers
- Medical cannabis in France: Latest state of play
- Belgium: Mobile health apps not yet reimbursable
- French medicines agency announces action against "short-liner" wholesale distributors
- French ANSM temporary scientific committee pursues activities on modalities of medical cannabis availability
- French Competition Authority delivers its opinion on consumer supply of medicines
- Belgian Minister of Health introduces new measures that will produce significant annual savings
- Belgium considers creation of cannabis agency
- ANSM grants first cohort ATU to a new indication of an authorised medicine
- New Belgian Royal Decree liberalises the distribution of medical devices
- French regulator (ANSM) imposes major financial penalty on a pharmaceutical company for shortage of medicine
- French 2019 Social Security Financing Act introduces new healthcare measures
- New Belgian life sciences regulations on pricing and clinical trials published
- French State held liable in PIP case
- French regulator (ANSM) introduces third fast-track authorisation procedure for clinical trials
- New Belgian Healthcare Act: Impact on the health sector
- French pharmacist representatives call for implementation and expansion of biosimilar substitution
- French ANSM recommends medical use of cannabis under certain conditions
- US FDA recognises GMP inspections from Belgian Federal Agency for Medicines and Health Products
- Has the Orphan Regulation met its aims? A critical review of the EU's incentives regime for rare disease patients
- 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
- Processing of health data: first implementing decree on French Personal Data Protection Act
- 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
- Revised French Personal Data Protection Act: Constitutional Court upholds health related provisions included in the bill
- 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
- Spain issues recommendations for distributors to detect and report misuse and unlawful diversion of human medicines
- 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
- Innovators can protect data exclusivity in Concerned Member States following a decentralised procedure
- 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?
- Italian reform of clinical trial rules out of the starting blocks
- 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
- EMA survey of UK based pharmaceutical companies on Brexit plans
- 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
- European Commission clarifies framework applicable to food for special medical purposes
- French Competition Authority launches sector inquiry into medicinal products and biomedical laboratories
- 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
- Italian Regions cannot recommend against use of costly medicines – says highest administrative court
- 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?
- Italy unlocks corporate investments in retail pharmacies
- French Supreme Court confirms discriminatory abuse in market of medical information databases for pharmaceutical companies
- 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
- European Commission seeks public views on health and care in the Digital Single Market
- BeneluxA collaboration joint pricing negotiations fail
- Portugal and Spain strengthen collaboration with pilot project for the joint procurement of medicines
- French Competition Authority announces healthcare sector enquiry during presentation of 2016 Annual Report
- 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
- New National Institute for Health Data responsible for access to health data in France
- Italian Medicines Agency warns MA holders of products imminently subject to ‘sunset clause’
- Belgium: FAMHP issues guidance for clinical trial pilot project
- Application of Clinical Trials Regulation postponed to 2019
- France further clarifies scope of clinical trial rules
- Excessive pricing of medicines and antitrust: not a great week for Aspen
- EMA launches public consultation on the notification of serious breaches of Clinical Trials Regulation or clinical trial protocol
- CJEU confirms that generally accepted nutrition and health principles are a legitimate factor for the evaluation of health claims made on food
- New requirements for Temporary Authorisations for Use in France
- DG COMP 2016 Report on Competition Policy: overview on the Life Sciences sector
- European Commission & EMA publish regulatory guidance for pharmaceutical companies post-Brexit
- Advertising to the public of all non-prescription medicines (not just OTCs) now permitted in Italy
- 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
- Belgium's absolute advertising prohibition for oral and dental care services incompatible with EU law
- EU medical device regulations published today – entry into force 25 May 2017
- Belgium adopts law to prepare for Clinical Trials Regulation implementation
- Food Supplements: CJEU sets boundaries to national legislation imposing maximum amounts on nutrients
- Spain simplifies MA variation procedure for medicinal products
- EMA issues revised guidance on the publication of clinical data on medicinal products for human use
- European Commission releases report on proposed improvements to PLs and SmPCs for medicinal products
- Revised French transparency regime enters into force
- Dutch court prohibits disclosure of information by Medicines Evaluation Board
- Competition Authority reviews regulation of wholesale distribution and marketing of medicines in Spain
- Belgian multiannual framework agreement to streamline delivery of medicines
- New EU medical device regulations adopted
- 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
- The Spanish Competition watchdog issues report on the proposed implementing provisions of the Patent Act
- 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
- Italian Medicines Regulator and Competition Authority enter into collaboration agreement
- The Netherlands puts itself forward as a candidate for future EMA location
- The Belgian Sunshine Act: what's in a name?
- Spain encourages clinical trial sponsors to involve ethics committee in Voluntary Harmonisation Procedure
- 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
- EMA advances in implementation of transparency policy and publishes new clinical data
- 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
- The Court of Justice confirms that products that are objectively foodstuffs fall under the scope of the EU Nutrition and Health Claims Regulation
- 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
- Implementing Decree marks official start for health-related class actions in France
- 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
- 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