How can Cevidra help you access the French pharmaceutical market?
#MarketAccess #MarketingAuthorisation #PricingReimbursement
Cevidra offers services for French pharmaceutical market access: product registration, pricing and reimbursement & market launch. There are many complex steps and processes between the production of a molecule in the R&D phase and its availability as a commercial product on the market.
Although harmonised at European level, the regulatory environment does not erase the MAH’s legal obligations in a given territory, such as France.
Registration Strategy & Advice
A company wishing to market its product in Europe must follow the steps required to obtain a marketing authorisation at a European or national level.
There are four ways in which a medicinal product can obtain a marketing authorisation in France:
The centralised procedure (CP)
The national procedure (NP)
- The mutual recognition procedure (MRP)
The decentralised procedure (DCP)
The choice of procedure depends on different criteria such as the number of countries in which the medicine is going to be marketed, or the type of medicinal product concerned. To navigate this complex environment, regulatory support is necessary to properly define the registration/marketing strategy.
Cevidra enjoys a privileged partnership with regulatory experts and offers all services necessary to support in the best ways a company as it crafts its regulatory strategy.
MA Application Preparation
The application must be prepared in accordance with guidelines defined by the EMA (European Agency) for European procedures or by the ANSM (National Agency) for French national procedures.
The MA application must be drafted in a regulatory or e-CTD format which requires substantial resources and investment for the drafting, compiling, and publication of documents and subsequent submission of applications for European registration (MRP, DCP, CP) or registration in France.
Cevidra and its regulatory experts support you throughout the evaluation process, ensure proper management of interactions with the agency and coordinate answers to questions raised by public authorities within the deadlines imposed by these same health authorities.
We offer to manage the MA application process until the authorisation is granted and to liaise with all stakeholders (MA holder, regulatory expert, Agency).
National Packaging Approval
The requirements for the labelling of a medicinal product distributed in France are defined in part by Annexes III A and III B of the marketing authorisation and in part by the Public Health Code. The MA holder is responsible for ensuring that parts III A and III B adjust to regulatory developments and the product’s lifecycle.
Cevidra will provide you with the expertise you need to bring all packaging elements into line with French regulations. Any amendment to Annexes III A and III B must be cleared by an authority following the submission of an amendment application by the MA holder.
The French mock-ups are prepared jointly by the MAH and the exploitant in France before they are submitted to the French Agency for approval.
Once approved by the authorities, the mock-ups are used as a reference for the manufacture of the medicinal product packaging components. The manufacturing of packaging components is the responsibility of the manufacturer, a process in which the exploitant intervenes to ensure that packaging meets local requirements. This process is of course a prerequisite for the marketing of a medicinal product in France.
The role of the exploitant
Cevidra, acting as an exploitant*, is familiar with French regulation, interacts periodically with the French health authorities, and can provide support and expertise on the long journey to market entry.
* exploitant = the appointment of a local company acting as a pharmaceutical operator is mandatory for all companies wishing to place a medicinal product on the French market.
Pricing & Reimbursement (P&R)
The reimbursement process
The French P&R process is well known for its complexity and length. As in all countries, it is nevertheless a key step in the marketing of a product as the level of reimbursement and price need to enable you to meet your objectives on the French market.
The process starts with the reimbursement procedure which is handled by the HAS. An application (NIT: Note of Therapeutic Interest) must be prepared and compiled with sufficient data to demonstrate the medical benefit expected from this new medicinal product. This application is based on:
Clinical data & real-life experience (RWE: Real World Evidence)
Whether it fits within the therapeutic strategy
The superiority or equivalence to clinical comparators
Innovative product or medical care improvement
At the end of the evaluation process (around 4/5 months after the submission), results are provided through a SMR/ASMR grade corresponding to:
SMR – Medical Service Provided (Effectiveness & Tolerance/Therapeutic strategy & competitors Interest for public health)
ASMR – Improvement of Medical Service Provided (Therapeutic progress)
These criteria are used to define the eligibility to reimbursement, the level of reimbursement, and have of course, an impact on the next steps: pricing.
The Pricing Process
When the product is reimbursed by Social Security, the price of the medicine is the result of a negotiation between the company holding the marketing authorization and the CEPS.
*Note that for expensive products, mainly intended for hospitals, a specific and complementary procedure must be jointly undertaken by the holder and the Exploitant.
Since 2007, Cevidra has been pharmaceutical exploitant…
For years, Cevidra has integrated new products in its portfolio on behalf of MAH and has acquired experience in the P&R process.
Cevidra can manage all the steps below:
Definition of the P&R strategy
- Preparation of the HAS and CEPS applications
Coordination of experts to back the applications
Submission and follow-up of the applications with Administrative Bodies
Interactions with public authorities
Direct negotiations with the CEPS on behalf of the MAH
Referencing on hospital & wholesalers platforms
In parallel with the P&R procedures, supplier and product referencing must be anticipated with the hospital purchasing platforms and wholesalers. Supplier means the company in charge of providing the products to the hospitals or wholesalers. In France, product distribution is the responsibility of the exploitant.
The referencing application is an administrative step and is not a single procedure as, for example, each hospital platform has its own procedure. This step is a pre-requisite to the ordering process and must be completed in a timely manner so that orders for product can start immediately after the completion of the P&R process.
Cevidra has strong expertise in the long and arduous process of product registration. With the support of the manufacturer and the MA holder, we can manage the different steps leading to your products’ administrative approval.
Pharmaceutical Databases (CIP, Serialisation & Vidal)
Product declaration and registration in the pharmaceutical database is mandatory by law.
The registration in the CIP database is essential for the reimbursement of the product as a unique code is assigned to the medicinal product, which will be useful throughout the product’s market lifecycle.
Other declarations are required to meet all obligations, which are the responsibility of the exploitant.
Cevidra, acting as exploitant, completes all the mandatory declarations and helps you navigate this complex environment.
Bidding in Public tenders
To market your medicinal product to hospitals, you must respect and follow the public procurement tendering process. This system ensures that medicinal products and their suppliers are subject to tenders in accordance with the public procurement code.
These calls for tender are published frequently on different online purchasing platforms, specific to each purchasing grouping. Each grouping represents a different number of hospitals throughout the country.
Cevidra, through its portfolio and history, has acquired significant expertise in this area.
We offer the following services:
Daily monitoring of public procurement tenders (AOMPs)
Competitive intelligence to craft the best pricing strategy
Reporting to the MAH
Preparation of the product/supplier application for participation in a tender
Bids in tenders after approval by the MAH and monitoring