ANSM

French Good Pharmacovigilance Practices (BPPV)

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The French National Competent Authority, “Agence Nationale de Sécurité du Médicament et des Produits de Santé” (ANSM) aim to guide all stakeholders involved in the French pharmacovigilance system, including healthcare professionals, patients, ANSM, Regional Pharmacovigilance Centers (CRPVs), and pharmaceutical companies (Marketing Authorisation Holders and “expoitant”). They define the responsibilities of each stakeholder and provide a framework for ensuring effective pharmacovigilance activities. The latest version was published in May 2022.

In France, pharmacovigilance is central to ensure medicinal product safety. Its purpose is to monitor, assess, prevent, and manage the risks associated with adverse reactions to medicines throughout their entire lifecycle, both before and after marketing authorisation.

A French Framework Aligned with European Requirements

French Good Pharmacovigilance Practices must be interpreted in conjunction with the European Good Pharmacovigilance Practices (GVP) developed by the European Medicines Agency (EMA).

The May 2022 update reflects the strengthening of pharmacovigilance requirements at both national and European levels and incorporates regulatory changes resulting from the reform of France’s early access and compassionate use framework.

For pharmaceutical companies, compliance requires a dual approach:

  • Adherence to European pharmacovigilance requirements;
  • Consideration of French-specific obligations, particularly regarding local pharmacovigilance organization, the role of the French Pharmacovigilance Responsible Contact Person (RPV), and interactions with national authorities.

The Central Role of the MAH and exploitant

One chapter of the French GVP is dedicated to the responsibilities of the MAH and the exploitant, making it particularly relevant for pharmaceutical companies operating in France.

To further support implementation, ANSM published a dedicated FAQ, updated in January 2026, providing clarification on several operational aspects of pharmacovigilance system management in France.

Key points include:

  • The appointment and responsibilities of the RPV;
  • The RPV’s oversight on pharmacovigilance activities, including Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), risk minimisation measures, computerised systems, and the European en local Pharmacovigilance System Master File (PSMF);
  • Business continuity for pharmacovigilance activities;
  • PV cases reporting and submission requirements;
  • Signal management;
  • Oversight of subcontracted activities;
  • Additional guidance on quality management systems, including audits, archiving, business continuity plan, and control of computerised systems.

For pharmaceutical companies, these clarifications reinforce the importance of maintaining a well-documented, robust pharmacovigilance system that is effectively managed at the local level.

Adverse Event Reporting: A Shared Responsibility

The reporting of adverse events is the fundamental element of the pharmacovigilance system.

Healthcare professionals are required to report any suspected adverse reaction related to a medicinal product, regardless of the circumstances under which it occurred, including special situations without adverse events, for example: off-label use, misuse, abuse, overdose, medication errors, occupational exposure, etc.

Patients and healthcare professionals may also report suspected adverse reactions through the ANSM reporting portal. PV cases submitted through this platform are directed to the appropriate entities, including the CRPVs.

For MAHs and exploitant, this requires clear processes to:

  • Identify PV cases from all relevant data sources;
  • Ensure proper medical assessment and regulatory requirements;
  • Meet regulatory submission timelines;
  • Maintain the quality and traceability of collected information;
  • Conduct appropriate follow-up when initial PV case information is incomplete.

Outsourcing Does Not Transfer Responsibility

Many pharmaceutical companies subcontracts some or all of their pharmacovigilance activities, including case processing, scientific literature monitoring, regulatory intelligence, safety report management and signal management. However, it does not transfer regulatory responsibility of the MAH or exploitant.

The MAH or exploitant retains ultimate responsibility and must maintain adequate oversight of service providers through written agreements and contracts, quality procedures, performance indicators, audits and periodic performance reviews.

Preparing for ANSM Inspections

Compliance with French GVP must be demonstrable at all times. Any pharmaceutical company subject to ANSM inspection should be able to present a complete, documented, and operational local pharmacovigilance system.

Inspection focus areas may include:

  • Local pharmacovigilance organisation;
  • Responsibilities and oversight of the RPV on PV activities;
  • The pharmacovigilance quality system;
  • Interfaces with partners and service providers;
  • Pharmacovigilance case management;
  • Local and global signal detection;
  • PSURs and RMPs;
  • Pharmacovigilance training;
  • Computerised systems;
  • Business continuity plans;
  • Audits and CAPA management.

Successful inspection readiness relies on regular audits, mock inspections, structured document reviews and risk-based action plans.

The French GVP operate within continuously evolving European regulatory framework. For MAHs and exploitant, pharmacovigilance compliance should be fully integrated into the company’s overall governance strategy.

A robust pharmacovigilance system not only ensures regulatory compliance but also enhances product safety, improves the quality of safety data, facilitates inspection readiness, and ultimately contributes to the protection of patient health.

ATESSIA’s pharmacovigilance consultants support pharmaceutical companies in the assessment and optimisation of their pharmacovigilance systems. Our services include audits, training, gap assessments, ANSM inspection readiness, document reviews, process compliance remediation, support for RPVs and CAPA plan management.

Article written by Marion PETOT, Pharmacovigilance Consultant

Rétrocession

The Hospital-to-Community Dispensing (“Retrocession”) of Hospital Medicines to Outpatients in France

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In France, community pharmacies are the standard point of dispensing for outpatients when medicines are not restricted to hospital use. 

“Retrocession” refers to the dispensing of medicines to outpatients by hospital pharmacies (PUI – pharmacies à usage intérieur), as an exception to or in addition to the community pharmacy supply chain. It is justified by public health or safety reasons listed in the French Public Health Code. 

According to Articles L5126-6 and R5126-58 of the French Public Health Code, and the dedicated page on the ANSM website, medicines must meet the following criteria to be eligible for rétrocession: 

  • not be restricted to hospital use (RH status), 
  • present specific dispensing or administration constraints, 
  • have particular requirements related to supply security, 
  • require monitoring of the prescription or dispensing. 
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Medicines are included on this list for public health reasons, in the interest of patients. 

The retrocession list, initially established in 2004 and managed by the Ministry of Health until 2021, was originally built on the basis of practice and needs. 
Its management was then transferred to the ANSM at the end of 2021 (Decree No. 2021-1531 of 26 November 2021). It is now supplemented by generic medicines corresponding to reference products already listed, or by certain new medicines considered by the ANSM to have added value when dispensed through hospital pharmacies due to safety-of-use or supply considerations. These medicines hold a Marketing Authorisation (MA) or an Import Authorisation (AI). The ANSM has expressed its intention to streamline this list, keeping only medicines that legitimately require access through this distribution channel. 

Decisions to include medicines on the retrocession list are published on the ANSM website approximately every 15 days, depending on the flow of newly granted MAs. A consolidated and updated retrocession list is also available (including antibiotics/antifungals, anticancer agents/immunosuppressants, antivirals, plasma-derived medicinal products, etc.). 

Other medicines may be dispensed through retrocession without being explicitly listed. These include the following categories: magistral or hospital preparations, medicines granted early access or compassionate use. 

The purpose of the retrocession system is to ensure that patients can access certain treatments despite specific distribution, dispensing, or administration constraints, or when particular monitoring of the prescription or dispensing is required, without the need for hospitalisation. 

When medicines have been marketed for several years and sufficient experience has been gathered, their switch to community pharmacy dispensing logically leads to their removal from the retrocession list. 

Atessia supports pharmaceutical companies in defining or modifying the prescribing and dispensing conditions of their medicinal products. 

This article was written by Estelle ICARD, Regulatory & Pharmaceutical Affairs Consultant. 

Atessia Quelle substitution des hybrides en france ?

What substitution for hybrid Medicines in France? Status of the ANSM Hybrid Groups Register

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A laborious creation of the register of hybrid groups 

The purpose of the hybrid group registry is to enable substitution in certain medical situations, taking into account the variety of “hybrid” situations. 

Thus, the creation of the hybrid group registry is the result of a long legislative process in France that led to the creation of hybrid groups and the hybrid group registry to address the potential risks associated with substitution: 

1- The first steps were introduced with the 2019 law related to finance of the French public health system (so-called LFSS*) and its decree no. 2019-1192 of November 19, 2019: these texts laid the foundations with the definition of the hybrid register and an initial framework for substitution; 

2- Next came the decree of April 12, 2022: this is the first list of ATC classes R03A & R03B of drugs that can be included in groups included in the hybrid register, i.e., drugs for obstructive airway diseases administered by inhalation. Since then, new ATC classes have been added; 

3- New details were provided in the decrees of January 31, 2023, with the medical situations: 

– in which substitution is possible; 

– in which the physician can exclude substitution; 

4- finally, everything actually has started with the ANSM decision of April 22, 2024: the creation of the register of hybrid groups and the registration of products in this register allowing the first substitutions on the pharmacy field. 

A variety of hybrid products 

    Hybrid medicinal products are defined in the French Public Health Code (Articles L5121-1 5°c) and R5121-28)) and in Article 10(3) of Directive 2001/83/EC as medicinal products that do not meet the definition of generic medicinal products: 

    – due to differences in the active substance, therapeutic indications, dosage, pharmaceutical form, or route of administration, 

    – or when bioequivalence with the reference medicinal product could not be demonstrated by bioavailability studies. 

    This definition therefore covers a wide variety of situations: let us cite topical drugs for which bioavailability is not achievable due to a local mode of action (e.g. dermatological, ophthalmic or pulmonary), parenteral drugs with a variety of pharmaceutical presentations, or even drugs which, for historical reasons, have heterogeneous therapeutic indications. 

    The content of the dossier depends on the reason for the hybrid drug. In many situations, substitution in pharmacies is not trivial. 

    However, it should be noted that, as with generic drugs, marketing authorizations for hybrid drugs refer in part to the non-clinical and/or clinical data of a reference drug that has had a marketing authorization for more than 8 years in France or the European Union. 

    In addition to this definition, the French Public Health Code defines: 

    – A hybrid group as the grouping of a reference drug and its hybrid drugs that can be substituted for it (Article L5121-1 5°d)). 

    – The register of hybrid groups, including substitutable hybrid groups (Article L5121-10). 

    *Loi de Financement de la Sécurité Sociale 

    In practice 

      Unlike generic medicinal products, inclusion in the hybrid group register is not automatic. However, the Marketing Authorisation Holder is not required to submit a request: it is the ANSM (French National Agency for the Safety and Health) that assesses the legitimacy of the product’s inclusion. 

      Hybrid groups are classified by active substance designated by its common name. 

      As with the generics register, the specialties listed in the register are classified by hybrid group. Each group includes the reference specialty (identified by the letter “R”) and its hybrids (identified by the letter “H”). 

      The hybrid group register indicates, for each product, its name, dosage, pharmaceutical form, and the name of the marketing authorisation holder and, if different, the name of the “Exploitant”. This register also includes the nature of any differences observed between a hybrid product and the reference product. Excipients with known effects are also included. Finally, the medical conditions for which substitution may be made are also specified, where applicable. 

      The decision to register is made on a case-by-case basis and is the responsibility of the Director General of the ANSM. 

      In the first versions of the register, only medicinal products belonging to therapeutic classes R03A and R03B used for obstructive pulmonary diseases have been included in the hybrid group register. Specialties belonging to the ATC classes relating to drugs used in dermatology (D01A, D05A and D08A) and relating to drugs used in ophthalmology (S01A and S01E) were added by decision of the ANSM in October 2025. 

      We are awaiting new registrations for the following ATC classes: 

      • A01AB – Stomatological preparations – Antiinfectives and antiseptics for local oral treatment 

      • D11A – Other dermatological preparations – Other dermatological preparations 

      • R02A – Throat preparations – Throat preparations 

      • S02A – Otologicals– Antiinfectives 

      The hybrid registry began with a sample of respiratory drugs, and has been fed with other drugs indicated in dermatology and ophthalmology. It is expected to expand further in the coming years. 

      Atessia supports its clients in their registration strategy for hybrid drugs in Europe. 

      Article written by Agathe DAUBISSE, Senior Regulatory Affairs Consultant