BlueReg
decision of the pharmaceutical company to launch the product in France or not. Pricing & reimbursement activities for the French market contact@blue-reg.com.
The Green Seed Group
company in the world representing 3000 almond growers. • 50+ % market share in the US. • Green Seed France introduced BLUE DIAMOND to the. French retail market
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ICHIBAN 13.50. Hamachi jalapeno
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Pricing & reimbursement activities for the French market
BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices) in France From pricing and reimbursement strategy to submission to the Authorities we provide flexible solutions to meet your company’s needs
What is the Blue Economy in overseas France?
The blue economy in Overseas France: 2.4% of market sector employment and 3.5% of businesses.
What is the French market for food products?
The French market for food products is mature, sophisticated, and well served by suppliers worldwide. Younger environmentally-conscious consumers and changing lifestyles contribute to France’s import demand for American consumer and food products.
What is French market collection?
French Market Collection is a wholesale manufacturer. We sell to the trade only. You may register as a dealer on our home page. Approved dealers must meet opening order and reorder requirements. All sales are final. We do not accept returns/exchanges on any of our products. We welcome your comments and questions about our products.
How difficult is it to enter the French market?
France's regulations and bureaucratic procedures can be a difficult hurdle for companies wishing to enter the French market and requires close attention by U.S. exporters. Complex safety standards, not normally discriminatory, but sometimes rigorously applied, complicate access to the market for many U.S. products.
CASE STUDY
MARKET ACCESS FRANCE
A global company recently entrusted to BlueReg the management of pricing and reimbursement activities to bring their product on the French market . Pricing and reimbursement strategy and activities are specific to each country. In France, the positioning of the product as compared to competitors, the presentation of data, their robustness (...) are key in the evaluation process. P&R activities are key activities for each company. A good understanding of the French market, of the process of evaluation, of past delivered opinions by involved authorities (HAS and CEPS) are crucial points. The results of negotiations with HAS and CEPS may determine the decision of the pharmaceutical company to launch the product in France or not. Pricing & reimbursement activities for the French market contact@blue-reg.com www.blue-reg.comSOPHIA ANTIPOLIS
PARISLONDON
AMSTERDAM
NEW YORK
BOSTON
BlueReg support
BlueReg has a broad experience in strategical market access activities. BlueReg put together a dedicated team of pharmacists with appropriate expertise, and project management skills to meet the HAS and CEPS requirements and to best satisfy the client's expectations.The activities covered by BlueReg senior
consultant team were: - Provision of strategical advice/guidance: On the positioning of the product, strengths and weaknesses of the project / productOn provisional timelines
On all expected steps and interactions with HAS and CEPSOn the format of the dossier for a compliant
electronic / paper submissionWriting activities:
Preparation of HAS dossier
Preparation of CEPS dossier
Collection and implementation of experts'
comments in above-mentioned dossiers Preparation in due time of the responses to the questions raised during evaluation processSupport for hearing at the HAS:
Preparation of the slide kit
Organisation of the rehearsal before actual meeting with AuthoritiesProject Management:
Main contact point with the client, the board of experts and the AuthoritiesCoordination of project team activities
Communication with the different parties
Respect of timelines
Sharing of information with headquarters / affiliate according to clients' expectations throughout the whole processChallenges
The project involved several activities (strategical advice, writing, hearing preparation) with tight
submission dates and with multiple actors: client headquarter and local affiliate, board of experts and Authorities. These activities were key for the client as they determine the decision of the launch of his product on the French market. During this project, a strong relationship was built, with the client putting their full trust inBlueReg expertise in market access activities.
Achievements
- Preparation of a slide presentation to describe market access (pricing and reimbursement process) - Preparation of a feasibility / positioning analysis for the product on the French marketData analysis
Environmental analysis: comparators, therapeutic strategy, public health needsSynthesis: risk analysis, opportunities
- Preparation of the dossier for submission to the transparency commission for the inscription of the product on the list of reimbursable medicines for persons covered by social security and community list - Preparation of the pricing dossier to be submitted to the CEPS (Health Products Economic Committee) - Actual submission to the HAS (through electronic platform) and the CEPS - Preparation of a slide kit for hearing with HAS - Coordination and participation in several meetings with the client and the board of experts - Management of tight timelines according to client's expectations and Authorities' requirements - Full client satisfaction, with great appreciation of the team's expertise and strong relationship for P&R activities. Management of tight timelines according to client's expectations and Authorities'How BlueReg can support you ?
Market Access France
BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices) in France. From pricing and reimbursement strategy to submission to the Authorities, we provide flexible solutions to meet your company's needs.Our services
Strategic consultancy for pricing and reimbursement: - Recommendation on reimbursement and pricing strategy - Expertise through the complete reimbursement process: new drugs and extension of indications or reassessmentPricing and reimbursement application support
- Writing of reimbursement dossiers for the Haute Autorité de Santé / French National Authority
for, Health (HAS) (new registration, renewal, change of registration conditions and reassessment)- Writing of pricing dossiers for the Comité Economique des Produits de Santé / French Economic
Committee for Healthcare Products (CEPS): new registration and price increase - Compilation and submission of the dossiers - Interaction with authorities at every stage of the reimbursement processOur latest engagements
- Strategic consultancy for pricing and reimbursement for a company launching an innovativemedicinal product in the French hospital market - Writing of pricing and reimbursement files for a new medical device
- Preparation of a meeting with the French National Authority for Health (HAS) contact@blue-reg.com I www.blue-reg.comFor more information please contact usWhy work with BlueReg ?
The team can provide full support for all aspects of the pricing and reimbursement process from registration to product maintenance activities providing strategic consultancy and/or hands-on operational support.Follow us on social media !
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