What is advertising or promotion of a medicinal product?
Advertising of medicinal products for human use means any form of information, including canvassing, prospecting or incentive, which is intended to promote the prescription, supply, sale or consumption of such products.
It is essential to understand French regulation before laying out a promotional strategy. Your product’s features, the nature of the users and/or prescribers, and the reimbursement of the treatment by the health insurance system will determine the regulatory framework for authorized advertising and promotional activities.
How to have your promotional material validated?
The ANSM’s recommendations for developing promotional material are numerous and strict, and it is advisable to have your material checked and corrected by a regulatory expert.
Once this review has been completed, the material will be submitted to public authorities for approval via the “Simplified procedures” platform. The submission of the advertising material must be accompanied by the payment of a fee paid in advance.
When all the elements necessary for filing are ready, the submission of these documents on this platform can only be done during periods defined in advance by the ANSM. For advertisements targeting health professionals, this review is open 4 times a year and each period lasts approximately 20 days.
The ANSM will provide a reply regarding the conformity of your document within two months following the date of the end of the submission.
In case of explicit or tacit agreement from the authorities, you will obtain an advertising visa which should be included on the material. This visa is valid for 2 years.
Cevidra offers all support activities to obtain authorization of promotional documents, such as regulatory review, preparation of the material by a graphic designer and submission to the Agency.
What do you need to do to set up a sales force?
Providing medical information
The activity of providing medical information by canvassing health professionals can only be carried out by qualified persons and following a scheme certified by an independent body that is itself accredited by the health authorities.
Promotional activity: the legal environment
Indeed, the authorities have set up a certification framework detailing the requirements to be followed to carry out a promotional activity by canvassing via medical representatives (KAM). This organisation is audited every year by an independent body to issue a certificate of compliance with the Health Visit Charter.
Canvassing
Canvassing is under the responsibility of the product Exploitant and can be carried out by the Exploitant but can also be subcontracted to a medical visit provider. The service provider must be certified pursuant to the Health Visit Charter.
How Cevidra can help?
Cevidra offers to build this sales force with you and to train medical sales representatives so that they can promote your medicines while meeting the expectations of public authorities and health professionals.
We also guarantee compliance with the requirements of the anti-gift law (or DMOS law) and the law on the transparency of links governing relations between the Exploitant laboratory and health professionals. Indeed, whatever the nature of the relationship (meal, invitation to a congress, scientific advice, etc.) that you wish to establish, it must be subject to an agreement which must be declared to or approved by the Council of the Order of Health Professionals.
These declarations must be made prior to the implementation of the relationship between the health professional and the Exploitant laboratory. The relationship is then declared by the Exploitant on the website dedicated to the transparency of links of interest.
Main takeaways
Sales
Market analysis, marketing through public tenders to hospitals, sales monitoring and customer relations, and turnover declarations to the authorities are key elements in achieving your objectives.
Do you know the French medicinal products market?
We can act upstream of sales to define with you the best strategy according to the medicinal products already available, the pathology concerned, the reimbursement terms of existing products and the features of your medicinal product.
This analysis will allow you to check the relevance of your project and adjust it if need be.
How to sell your medicinal products to hospitals?
Your product is mainly or exclusively dependent on the hospital market. There, you must comply with the necessary administrative rules and processes.
Public Procurement Tenders
Each medicinal product is subject to public procurement tenders allowing for competition between medicinal products and their suppliers, in accordance with the public procurement code.
Purchasing Platforms
These tenders are frequently published on different online purchasing platforms, specific to each purchasing grouping. Each grouping represents a different number of hospitals throughout the country.
Calls for Tenders
Hospitals choose based on various criteria: price, but also the quality of the supplier’s services (supplies, deliveries, medical information, commercial actions, etc.).
Answering Public Tenders
The response to these calls for tenders is done by digital means, requiring appropriate access and IT tools (identifiers to the different platforms, electronic signature certificates, encryption of tenders).
Contract between the MA holder and Hospitals
The selected medicinal product is then subject to a contract between the hospital and the contract holder, the period of which may vary from 12 months to several years.
How do we deliver, invoice and collect?
Delivery and invoicing of customers is handled by our logistics and customer service department.
For public institutions, this invoicing is necessarily digital, through the CHORUS PRO platform, a shared solution set up for all suppliers (private or public) in the public sphere (State, local authorities, etc.) to meet legal obligations regarding electronic invoicing.
We regularly monitor sales and maintain an up-to-date statement of collections. This allows us to provide a full statement of sales, invoiced and recovered amounts at the rate requested by the MA holder.
What are the financial consequences of selling a medicinal product in France?
The sale of your medicine on the French market is the Exploitant’s responsibility.
The turnover generated in this way is subject to various taxes and reporting obligations to the health authorities. These obligations are mainly defined in the Social Security Code.
CEVIDRA assists you or makes these declarations as an Exploitant. These turnover declarations and the taxes linked to these declarations depend on whether your product is in early access or if it is marketed with its marketing authorisation.
We describe these obligations and propose a process for paying these taxes in our service offer.