How to market a drug in France? Centralized Marketing Authorization and other cases
Marketing Authorization (MA) is a mandatory step after the development of a drug. It confirms that the product has demonstrated a favorable benefit/risk ratio, based on a complete MA dossier including data on quality, safety, and efficacy. However, obtaining this MA, whether standard or conditional, is not enough to make a drug available to patients. In France, several additional steps are necessary to reach the stage of marketing a drug or pharmaceutical product.
In this article, we detail the key steps to be taken after Marketing Authorization to ensure rapid and compliant access to the French market.
Marketing Authorization: essential but not sufficient
Before a drug can be marketed in France, it must have Marketing Authorization, issued either at the national level by the ANSM or at the European level by the European Medicines Agency (EMA). The EMA is responsible for the centralized procedure, which is mandatory for certain classes of drugs (e.g., biotechnologies or treatments for cancers or orphan diseases) and optional for others (e.g., when the drug represents a therapeutic innovation).
Drugs may also be authorized through other European procedures, such as mutual recognition or decentralized procedures, coordinated between several Member States.
When a medicine needs to be made available more quickly because it meets an unmet medical need, Marketing Authorization may be conditional. This type of MA is used in particular for serious, rare, or life-threatening conditions where a potential therapeutic benefit has been demonstrated despite the lack of comprehensive clinical data. These marketing authorizations, supervised by the EMA, are subject to strict post-marketing obligations.
However, regardless of the procedure followed, Marketing Authorization is only the first step. Once authorization has been obtained, the holder must still complete several steps to actually place the product on the French market.
NB: This article applies mainly to drugs that have obtained centralized Marketing Authorization, but the principles are similar for national or decentralized Marketing Authorizations, with some variations in procedure depending on the competent authority (EMA or ANSM).
Appointment of a local exploitant for marketing
In France, a drug cannot be marketed without the appointment of an exploitant laboratory, as required by the Public Health Code. The exploitant is not necessarily the holder of the Marketing Authorization, but must be established on French territory. It acts as the official contact for the ANSM for all operations related to the manufacture and marketing of the drug.
Beyond this regulatory role, the exploitant is responsible for the proper execution of a number of essential activities, including:
- Advertising to healthcare professionals, in compliance with the legislative framework in force.
- Wholesale or free transfer, according to the channels defined by the regulations.
- The dissemination of reliable medical information to healthcare professionals and/or patients.
- The implementation of an operational pharmacovigilance system that complies with post-marketing authorization requirements.
- Batch tracking, including traceability and management of batch recalls if necessary.
- Storage activities, ensuring that the medicinal product is stored under optimal temperature and safety conditions.
The exploitant is also responsible for submitting the drug marketing declaration form to the health authorities (ANSM), which is essential for officially launching the drug on the French market. Its role is therefore strategic, regulatory, and operational, at the heart of the drug marketing system in France.
See also: What are the EMA’s timelines for the standard and accelerated procedures?
Regulatory and administrative procedures
Once the exploitant has been designated by the Marketing Authorization holder and the declaration form has been submitted to the ANSM, several administrative steps must be completed before the product can be placed on the market. These include packaging validation: the commercial packaging of the medicinal product (box, package leaflet, label) must comply with the information approved in the Marketing Authorization dossier. Any subsequent change in presentation or modification of the packaging wording must be subject to a regulatory variation, to be submitted to the ANSM or the EMA, depending on the type of Marketing Authorization.
These variations are classified according to their impact: type IA for minor changes with no clinical consequences, type IB for moderate changes requiring review, and type II for major changes likely to affect the quality, safety, or efficacy of the drug. Marketing with the new packaging can only take place after final validation by the Chief Pharmaceutical Officer of the exploitant site.
Other steps may also be necessary: validation of prices and conditions of prescription and dispensing, particularly if the drug is intended to be covered by health insurance (see next section), as well as information or promotion of drugs to healthcare professionals, regulated by regulations on drug advertising. Materials such as brochures or product datasheets may then be distributed under the responsibility of the exploitant.
See also: How to manage regulatory variations of a Marketing Authorisation (MA)?
Pricing for market access
For drugs intended to be covered by health insurance (Social Security reimbursement), access to the French market involves a two-step process: medical-economic evaluation and price negotiation. Two key bodies are involved:
- The HAS (Haute Autorité de Santé), via the “Commission de la Transparence”, evaluates the medical service provided (“SMR: Service Medical Rendu”) and the improvement in medical service provided (“ASMR: Amélioration du Service Médical Rendu”) of the drug. This evaluation influences the level of reimbursement (or coverage).
- The CEPS (Comité Economique des Produits de Santé), which negotiates the sale price of the drug with the pharmaceutical company.
Logistics and post-marketing obligations
Once the product has been authorized for sale, other considerations must be anticipated to ensure compliant, safe, and sustainable marketing.
Distribution
The distribution of medicinal products for human use must comply with Good Distribution Practices (GDP) as defined by the guidelines of November 5, 2013 (2013/C 343/01). These GDPs aim to ensure that the quality and integrity of products are preserved throughout the supply chain. They require that medicinal products be distributed only by establishments holding wholesale distribution authorization and that they be delivered only to authorized persons or entities, in particular retail pharmacies or hospital pharmacies.
The supply chain must allow for complete traceability, with a documented system ensuring the identification of each product movement. Medicines must be stored, transported, and handled under appropriate conditions to prevent any deterioration, including temperature control, packaging integrity, and protection against contamination.
An effective system for managing complaints, returns, product recalls, or the identification of counterfeit medicines must also be in place. All operations must be carried out under the responsibility of a qualified person (in France, the Chief Pharmaceutical Officer) and be subject to comprehensive documentation to enable regulatory audits and inspections.
Pharmacovigilance
Marketing Authorization requires the monitoring of adverse effects through an operational pharmacovigilance system, for which the exploitant is responsible locally. The data collected is sent to the Marketing Authorization holder, who updates the safety information on the drugs described in various documents intended for healthcare professionals and patients (such as risk management plans (RMPs), Summary of Product Characteristic (SmPC) and leaflet for the patient.
Regulatory monitoring
Periodic safety update reports (PSURs), post-marketing surveillance studies (particularly in the case of conditional MAs), and summary reports on the efficacy and safety of drugs must be submitted to the authorities. In addition, any change to the drug or its conditions of use (e.g., new indication or change in dosage) requires a variation application to be submitted to the ANSM or EMA, depending on the type of initial procedure.
Conclusion
Obtaining Marketing Authorization is a crucial step, but it is only the beginning of the journey toward commercializing a drug in France. From choosing an exploitant to submitting applications to the ANSM, including pricing requests and compliance with post-marketing obligations, each step must be carefully planned in advance.
A thorough understanding of the French regulatory framework, combined with strategic and operational support, is essential to ensure rapid, secure, and compliant access to the French market.
