This merger enriches our service offering and affirms our commitment to supporting healthcare players in meeting the regulatory and operational challenges of today and tomorrow.
This union marks the coming together of Dr. Nathalie CASABURO and Dr. Géraldine BAUDOT-VISSER: two experts driven by a shared vision of excellence at the service of healthcare players.
Two visions, a shared ambition Created in 2004, AnticipSanté has established itself as a key player in health vigilance, thanks to its expertise and local approach. Today, this entity joins Atessia to form a strategic alliance combining innovation, personalization and excellence.
This integration embodies our determination to transform regulatory challenges into opportunities, and to provide our partners with sustainable solutions adapted to changes in the sector.
In the intricate and highly regulated world of pharmaceuticals and healthcare, ATESSIA stands out as a consulting firm dedicated to guiding companies through the complexities of regulatory affairs. Recognizing the critical role of compliance and patient safety, ATESSIA offers comprehensive expertise that spans scientific documentation, clinical trials, regulatory submissions, and pharmacovigilance. By ensuring seamless collaboration with regulatory authorities across multiple jurisdictions, ATESSIA helps companies achieve compliance while driving growth and maintaining a strong focus on patient welfare and product efficacy.
Regulatory Affairs: a Growth Engine
Regulatory affairs are far more than a checklist of tasks—they represent a strategic driver of growth and innovation within the pharmaceutical and medical device sectors. At their core, they ensure that products meet the highest safety and quality standards, from development to commercialization. This involves aligning manufacturing processes with legal requirements, maintaining ongoing communication with regulatory authorities, and managing the vast documentation required for regulatory submissions.
Regulatory affairs also operate as a vital connector, fostering collaboration across clinical, medical, and marketing teams to ensure that every stage of product development adheres to regulatory standards. Beyond compliance, they enable strategic growth by guiding research and development efforts, supporting faster market access through regulatory frameworks, and facilitating partnerships and licensing agreements. Moreover, regulatory expertise ensures that companies can enter new markets efficiently, navigating diverse local requirements while maintaining compliance for existing products as regulations evolve.
Balancing Regulatory Workload
An overburdened regulatory workload can strain a company’s resources, stifling growth and innovation. ATESSIA’s solutions address this challenge by alleviating internal pressures, allowing teams to focus on core activities such as clinical trials and market strategy.
By partnering with ATESSIA, companies gain access to a balanced approach to regulatory affairs. ATESSIA’s expertise accelerates market access by efficiently managing regulatory submissions and ensures operations remain cost-effective and controlled. As an independent consultancy, ATESSIA provides objective and unbiased advice, enabling clients to navigate the complexities of the regulatory landscape with confidence.
What makes french Regulatory Affairs unique and how can ATESSIA Help?
The French pharmaceutical market presents unique challenges and opportunities due to its distinct regulatory environment. Stringent requirements from the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), coupled with specific laws such as the Public Health Code, create a complex framework for compliance. ATESSIA acts as a strategic partner for international companies, offering expert guidance to navigate these complexities and thrive in the French market.
Key challenges include obtaining Exploitant status, adhering to packaging and labeling requirements, maintaining robust pharmacovigilance systems, and complying with strict advertising and anti-gift regulations. ATESSIA also supports companies in negotiating pricing and reimbursement with the HAS (Haute Autorité de Santé) and the CEPS (Comité Économique des Produits de Santé), ensuring optimal market entry strategies and compliance.
ATESSIA’s Commitment to Customer Experience
Led by Géraldine Baudot-Visser, ATESSIA is built on a foundation of precision, flexibility, and a deep understanding of client needs. The company prioritizes tailored solutions, crafting regulatory strategies that align with each client’s specific context, sector, and objectives. With a commitment to transparency, ATESSIA ensures clear and open communication throughout every project, empowering clients to make informed decisions confidently.
This long-term partnership approach positions ATESSIA as more than just a regulatory consultant. By adapting to changing regulatory environments and supporting clients as they grow, ATESSIA becomes an essential ally in achieving compliance and fostering sustainable growth.
ATESSIA transforms regulatory affairs from an operational challenge into a strategic tool for success. By providing unparalleled support and expertise, the company helps pharmaceutical businesses navigate complex landscapes, achieve compliance, and capitalize on growth opportunities.
For more information, visit www.atessia.fr or reach out via email at hello@atessia.fr. ATESSIA’s team is ready to help optimize your regulatory affairs and support your strategic objectives.
To read the full article on Silicon Review, click here!
We are proud to be featured in The Silicon Review, a recognition that highlights our unwavering commitment to excellence in regulatory affairs.
In the pharmaceutical industry, regulatory compliance is more than a requirement—it is the foundation for driving innovation and safeguarding patient health. At ATESSIA, we tackle these challenges with precision and a strategic approach, helping our clients achieve their long-term goals.
Why partner with ATESSIA?
Streamlined Processes: We simplify regulatory workflows, enabling your teams to focus on innovation and clinical success.
Accelerated Market Entry: With deep expertise in French regulatory requirements (Exploitant status, pricing, market authorizations), we ensure a smooth entry into the French market.
Sustainable Compliance: Our tailored strategies align regulatory adherence with your budget and timeline constraints.
Independent Expertise: As an autonomous consultancy, we offer objective guidance backed by in-depth knowledge of the pharmaceutical landscape.
This achievement represents a key milestone in our mission to transform regulatory affairs into a strategic advantage for our clients.
Leveraging its expertise, ATESSIA supports a wide range of health products, with a particular focus on pharmaceuticals and medical devices. Through a tailored and rigorous approach, the firm helps its clients navigate complex regulatory landscapes, ensuring compliance and innovation in their projects.
More Human, More Agile
“I founded ATESSIA, Life Science Advisors, with the conviction that regulatory and pharmaceutical affairs consulting could be reimagined through a more human and agile lens,” explains Géraldine Baudot-Visser. Drawing on several years of experience in the pharmaceutical industry and renowned consulting firms, I recognized the opportunity to create a company that prioritizes client satisfaction and the empowerment of its experts while ensuring unwavering excellence in the pharmaceutical field.” The initial challenges naturally revolved around gaining the trust of the first clients and dismantling stereotypes about consulting. The firm needed to prove that rigor and creativity can coexist and demonstrate that a consulting firm can combine cutting-edge expertise with a bespoke approach. Striking the balance between managing a young company and delivering excellence has been a top priority since day one. For the founder, the goal was clear: to become a reference in regulatory consulting in the French and European markets within a few years, despite competition from established firms.
Tailor-Made Solutions, Continuously Enhanced
Every phase of ATESSIA’s growth has been driven by the ambition to establish itself as a leader while rallying employees around its clients’ challenges. Each step has also been an opportunity to reinvent, innovate, and grow while staying true to its values to ensure a client-centered approach. “For example,” says the founder, “our regulatory intelligence service is essential for our pharmaceutical clients, achieving a satisfaction and retention rate exceeding 90%. This success reflects our ability to provide tailored support and anticipate market changes, meeting the most demanding expectations of our partners.” This commitment to exceeding expectations relies on a team capable of anticipating, adapting, and ensuring compliance with the strictest standards. This collective dynamic keeps ATESSIA at the forefront, offering clients ever more efficient, custom-tailored solutions.
An Excellence-Driven Approach
“Our clients choose us because they seek far more than standardized solutions. At ATESSIA, we work with the precision of master artisans, designing bespoke solutions perfectly adapted to the specificities of each project in a highly regulated environment. Like the finest craftsmen of traditional expertise, we pay particular attention to ensuring impeccable quality in our services to provide reliable technical support to our clients,” shares Géraldine Baudot-Visser. This excellence-driven approach makes ATESSIA a trusted partner for its clients. The consulting firm builds strong relationships founded on attentive listening, in-depth expertise, and the ability to anticipate market changes. This proactive, personalized vision allows ATESSIA to deliver solutions that are always perfectly adapted and tailored.
“Every contribution we make to the healthcare industry, no matter how modest, has the potential to impact someone’s life somewhere. This gives profound meaning to what we do and makes every project-whether centered on pharmaceutical facilities, system quality, or innovation-much more than just a mission for us: it’s an opportunity to actively contribute to improving patients’ lives. This responsibility is a source of immense and invaluable pride,” she concludes.
The new regulation (EU) 2017/745 introduces new requirements to enhance the safety of patients and users. One of the novelties of this new regulation is the creation of a European database dedicated to information on medical devices called EUDAMED.
This database will allow:
– Increased transparency of information on medical devices with public access.
– Better coordination between Member States in the post-market surveillance of medical devices.
EUDAMED is a secure platform used to collect and share data related to medical devices placed on the European Union market, as well as those undergoing clinical investigation.
The regulation introduces new requirements for the various actors involved in EUDAMED.
This database will consist of six interconnected modules:
Module :
Who needs to record information?
Accessible to the public
1-Actors
Economic operators must register as actors in EUDAMED and provide the required information.
– EU and third-country manufacturers, – Authorized representatives, – System/procedure pack producers, – Importers.
Available on a voluntary basis since December 2020 and will be mandatory from Q1 2026.
2-Devices
Manufacturers must submit the basic-UDI and information of all devices they place on the EU market into EUDAMED.
– Only manufacturers. Registration of medical devices under MDR. No obligation for legacy devices (if registered in EUDAMED, a new registration will be required for products under MDR, considered as new products).
Available on a voluntary basis since October 2021 and will be mandatory from Q1 2026.
3-Notified Bodies (NB) and Certificates
. Notified bodies must register in EUDAMED all information regarding issued, suspended, reinstated, withdrawn, or refused certificates and other restrictions imposed on these certificates. This information is accessible to the public.
– Notified Bodies.
Available on a voluntary basis since October 2021 and will be mandatory from Q1 2026.
4-Vigilance
Module dedicated to all vigilance and post-market surveillance reports. – Safety information (Field Safety Notice, FSN), – Field Safety Corrective Action (FSCA), – Investigation report of incident causes and corrective measures (MIR), – Trend report, – Periodic Safety Update Report (PSUR).
– Manufacturer.
Will be mandatory from Q3 2026.
5-Market Surveillance
Coordination of market surveillance actions between the various competent authorities.
This module concerns the registration of clinical investigations (MD) and performance studies (IVD). – Clinical investigation report and summary, – Serious adverse event during clinical investigations.
– Sponsor.
Not yet available.
Source : European commission
And the Distributors?
The MDR imposes no requirements on distributors regarding EUDAMED. They have no secure access to EUDAMED and only have public access. However, some countries may set additional requirements, such as France, which requires distributors to register via the ANSM form.
EUDAMED Deployment Schedule
In October 2019, the European Commission announced a two-year postponement of EUDAMED’s launch to May 2022.
Some modules are already available and can be used voluntarily. A roadmap project was released on July 10, 2024, indicating a full deployment of EUDAMED scheduled for the second quarter of 2027. The dates present in the EUDAMED roadmap are provisional and in “Draft” mode. No dates are official at this stage.
Recently, on January 21, 2024, the European Commission published a proposal to amend regulation (EU) 2017/745 on medical devices (MDR) and regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) concerning the gradual deployment of EUDAMED. This proposal suggests a gradual implementation of EUDAMED modules once validated, potentially starting in Q4 2025. This proposal will need to be adopted and published in the Official Journal by May 2024.
Since 1994, medical devices have had to comply with the requirements of European Directives 93/42/EEC and 90/385/EEC. Conformity with this regulation allows the affixing of the CE marking, enabling the free circulation of medical devices within the European Union (EU).
The European Union has recently revised this regulation through the European Regulation 2017/745/EU for medical devices (MDR), which finally came into effect on May 26, 2021. The adoption of a regulation instead of a directive ensures uniformity in the regulatory framework through its direct application.
This new regulation imposes new responsibilities on economic operators involved in the supply chain of medical devices: manufacturer, authorized representative, importer, distributor.
What are the main changes introduced by this new regulation (MDR)?
– Redesignation of Notified Bodies (NB) under MDR and EU control of Notified Bodies (NB)
– Improved traceability through the Unique Device Identification (UDI)
– Inclusion of certain aesthetic devices with the same characteristics and risk profile as medical devices covered by the regulation
– Enhanced transparency through EUDAMED, the medical device database
– Strengthened requirements for clinical data and post-market surveillance
What transition periods will apply?
Initially, the MDR was to come into effect on May 26, 2020. Due to the COVID-19 health crisis in 2020, the EU decided to postpone this date through Regulation (EU) 2020/561.
The implementation date was thus postponed to May 26, 2021, with a transition period for manufacturers with medical devices already on the European market (“LEGACY DEVICES”) until May 26, 2024 (end of the issuance of certificates under the directive) and the availability of these medical devices on the market until May 26, 2025. However, for class I medical devices and new medical devices entering the European market, they had to comply with the MDR since May 26, 2021.
On March 20, 2023, the EU assessed a potential shortage risk for many medical devices and adopted Regulation EU 2023/607, amending Regulation (EU) 2017/745 concerning transitional provisions (Article 120).
The extension dates of certificates under Directive 93/43/EEC are extended based on the class of the medical device:
However, manufacturers covered by this extension must meet the following conditions:
1/ The devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable. ;
2/ There are no significant changes to the design and intended use.;
3/ The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, considering other aspects related to public health protection. ;
4/ no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9); ;
5/ The manufacturer or authorized representative has lodged a formal conformity assessment request under the MDR for a medical device or a replacement device to a Notified Body by September 26, 2024, and the Notified Body and the manufacturer have signed a written agreement.
Special case for custom-made class III implantable devices – transitional period introduced:
The conformity assessment of custom-made class III implantable devices requires an assessment by a Notified Body.
Custom-made class III implantable medical devices can be placed on the market without the corresponding certificate until May 26, 2026, provided that the manufacturer has submitted an application to a designated Notified Body under the MDR before May 26, 2024, and has signed a contract with that Notified Body before September 26, 2024.
MDR requirements applicable from May 26, 2021:
However, it is important to note that certain MDR requirements shall apply to devices since May 26, 2021, such as requirements related to post-market surveillance, market surveillance, vigilance, and the registration of economic operators.
Removal of the availability date:
Additionally, Regulation EU 2023/607 completely removes the availability deadline, allowing “LEGACY DEVICES” to be available without a deadline (still respecting the device’s usage limit date). This removal also applies to in vitro diagnostic medical devices marketed before May 26, 2022, in Regulation (EU) 2017/746 (IVDR).
Are CE certificates under the directives still valid during this extension period?
Certificates that expired before the entry into force of Regulation 2023/607 (March 20, 2023) should only be considered valid if:
– Either before the certificate’s expiration date, the manufacturer and Notified Body signed a conformity assessment agreement before the certificate’s expiration date.
– Or if a competent authority has granted a derogation.
Notified Bodies can no longer issue or modify CE certificates under the directives since May 26, 2021. Therefore, they are considered extended unless they have been withdrawn.
Manufacturers can issue a self-declaration confirming that they comply with the extension conditions, indicating the end date of the transition period (the medical devices covered by the extension must be clearly specified). At the manufacturer’s request, the Notified Body can also issue a confirmation letter.
It is important to remember that despite these delays, manufacturers must now act toward this new regulation. The submission period to Notified Bodies can take from 6 to 18 months, depending on the Notified Body and the medical device.
Atessia supports its clients through all stages of MDR compliance.
Biological medicinal products are used in the treatment of numerous pathologies, such as diabetes, cancer and autoimmune diseases. Any biological medicinal product whose patent has fallen into the public domain can be copied: this is known as a “biosimilar”. A biosimilar is a medicinal product which, like any biological medicinal product, is produced from or derived from a cell or living organism, and whose efficacy and side effects are equivalent to those of its reference biological medicinal product. By February 2022, 67 biosimilar medicinal products had been authorized in the European Union.
The marketing authorization of a biosimilar medicinal product
The marketing authorization of a biosimilar medicinal product must meet strict regulatory requirements to demonstrate that its pharmaceutical quality, efficacy and safety are clinically equivalent to those of the reference biologic medicinal product. The ANSM maintains the reference list of similar biological groups registered in France. It is presented by common name of the active substance. It includes all the medicines registered in France with the legal basis of a “similar biological” marketing authorization file within the meaning of b of 15° of article L5121-1.
Since biosimilar medicinal products are derived from living organisms, they cannot be strictly identical to reference products. Consequently, the substitution principle, which applies to chemical medicinal products and their generics, cannot be applied automatically.
However, in the light of advances in knowledge, interchangeability and substitution during initial prescription or treatment can now be envisaged under strict conditions and within the framework of the indications, dosage regimens and routes of administration common to the reference product.
In order to guarantee proper use and safety during substitution, this substitution is introduced gradually in France. The right of substitution for biosimilars is decided at national level by each member state. In France, the order of April 12, 2022 first sets out the first two groups of biosimilars that can be substituted in pharmacies within a specific framework: filgrastim and pegfilgrastim (immunostimulant-cytokine agents).
More recently
More recently, the decree of October 31 and the decree of February 20, 2025 have expanded the list of similar biological groups that can be substituted by the community pharmacist and specified the conditions of substitution and information for the prescriber and the patient:
Filgrastim (2022)
Pegfilgrastim (2022)
Ranibizumab (2024)
Adalimumab NEW
Enoxaparine NEW
Epoétine NEW
Etanercept NEW
Follitropine alfa NEW
Teriparatide NEW
What’s the latest on biosimilar substitution in France?
> Prescription
The prescriber must inform the patient of the possibility of substitution by the pharmacist of the prescribed biological medicine. He can also indicate on the prescription which type of medical administration device is to be preferred for a given patient (adalimumab, etanercep, teriparatide).
> Dispensing
When dispensing, the pharmacist must inform the patient of the actual substitution and the associated useful information, in particular by recalling the rules for storing the specialty. He – mentions on the prescription the name of the medicine actually dispensed and informs the prescriber about the medicine dispensed. He records the name of the medicine dispensed by substitution and its batch number by all appropriate means in order to implement the traceability required for all biological medicines. Finally, he ensures the continuity of dispensing of the same medicine during subsequent dispensations.
For the following specialties, the pharmacist must also:
– substitute specialties with the same active substance dosage: Etanercept, adalimumab, enoxaparin, epoetin
– not substitute with a biosimilar that would have a higher injection volume than the prescribed medication: Adalimumab
For follitropin αlfa, the pharmacist:
– dispense a specialty that allows the administration of the exact dosage prescribed in the event of substitution of multi-dose pens by single-dose pens and vice versa,
– ensure that the patient has the appropriate pen in the event of dispensing of cartridges and support the patient in learning the new device,
– in the context of ovarian stimulation, ensures understanding of the protocol implemented including the prescribed dosage regimen and the administration methods of the specialty dispensed. ;
– supports the patient in learning the new device,
> The patient has the possibility of returning to the specialty initially dispensed if necessary, “based on their feedback” (adalimumab, enoxaparin, epoetin, etanercep, follitropin alfa, teriparatide).
> Finally, the laboratory provides dummy administration devices to healthcare professionals and patients (adalimumab, enoxaparin, epoetin, etanercep, follitropin alfa, teriparatide).
Atessia is monitoring this evolving subject on a daily basis.
Glossary :
– Biological medicinal product (article L.5121-1, paragraph 14 of the French Public Health Code): “any medicinal product whose active substance is produced from or extracted from a biological source and whose characterization and quality determination require a combination of physical, chemical and biological tests as well as knowledge of its manufacturing process and control”.
– Biosimilar” medicinal product (article L.5121-1, paragraph 15 of the French Public Health Code) “any biological medicinal product with the same qualitative and quantitative composition in active substance and the same pharmaceutical form as a reference biological medicinal product, but which does not meet the conditions laid down in 5° of this article to be considered as a generic, due to differences linked in particular to the variability of the raw material or the manufacturing processes, and requiring the production of additional preclinical and clinical data under conditions determined by regulation”.
– Reference medicinal product: biological medicinal product approved in the EU that a company developing a biosimilar medicinal product chooses as a reference point for direct comparison of quality, safety and efficacy.
– Interchangeability: refers to the possibility of replacing one medicinal product with another that is intended to have the same clinical effect. Interchangeability can be achieved in two ways:
– Permutation: when a prescriber substitutes one medicinal product for another with the same therapeutic intent.
– Substitution: the practice of dispensing a medicinal product in place of another equivalent and interchangeable medicinal product, without reference to the prescriber.
In France, the Public Health Code (PHC) defines different status:
Status
Authorised activities
Manufacturer
Manufacture of medicinal products, products or objects referred to in Article L. 4211-1 of the PHC
Importer
Import, storage, quality control and release of batches of medicinal products, products or objects referred to in Article L. 4211-1 from: States not members of the European Community or parties to the Agreement on the European Economic Area Or other Member States of the European Community or parties to the Agreement on the European Economic Area when the medicinal products, products or articles have been manufactured by an establishment not authorised under Article 40 of Directive 2001/83 of 6 November 2001 on the Community code relating to medicinal products for human use.
Exploitant
Exploitation of medicinal products other than investigational medicinal products, generators, kits and precursors mentioned in 3° of article L. 4211-1.
Depositary
Storage of medicinal products, products, objects or articles of which it is not the owner, with a view to their wholesale distribution and as is for the order and on behalf of: – one or more Exploitant of medicinal products, generators, kits or precursors mentioned in 3° of article L. 4211-1; – or of one or more manufacturers or importers of dressing objects or articles presented as complying with the Pharmacopoeia mentioned in 2° of article L. 4211-1 of the PHC.
Wholesaler
Purchase and storage of medicinal products, other than investigational medicinal products, with a view to their wholesale distribution as such
Wholesale distributor of pharmaceutical products other than medicinal products
Purchase and storage of intermediate products intended for further processing by an authorised manufacturer or of products, objects, articles, generators, kits or precursors referred to in 2° and 3° of Article L. 4211-1, with a view to their wholesale distribution and as such
Export Wholesale Distributor
Purchase and storage of medicinal products other than experimental medicinal products, products, objects, articles, generators, kits or precursors referred to in 2° and 3° of Article L. 4211-1, medicinal plants referred to in 5° of Article L. 4211-1, with a view to their export as such
Humanitarian wholesale distributor
Acquisition, free of charge or against payment, and storage of medicinal products other than investigational medicinal products, with a view to their wholesale distribution or export
Distributors of investigational medicinal products
Storage of investigational medicinal products manufactured or imported by companies or organisations defined in 1° or 2° of this Article (R.5124-2), with a view to their distribution as such for the order and on behalf of one or more sponsors defined in Article L. 1121-1
Wholesale distributor of medicinal plants
Storage and controls and operations necessary for the wholesale and bulk distribution, in sachet-doses, fragments or in a fresh or dried state of medicinal plants mentioned in 5° of Article L. 4211-1
Wholesale distributor of gases for medical purposes,
Purchase and storage of packaged gases for medical use, with a view to their wholesale distribution and as such
Wholesale distributor of the Armed Forces Health Service
Wholesale distribution of the medicinal products, products or objects referred to in Article L. 5124-8;
Pharmaceutical establishment for the protection of the population in the face of serious health threats
Purchase, manufacture, import and export of products necessary for the protection of the population against serious health threats, with a view to their distribution.
Pharmaceutical purchasing centre
Purchase and storage of medicinal products other than experimental medicinal products, with the exception of medicinal products reimbursed by compulsory health insurance schemes, with a view to their wholesale distribution as such to pharmacists who are the owners of a dispensing service either in their own name and on their own behalf, or in order and on behalf of pharmacists who are members of a dispensing or the structures mentioned in Article D. 5125-24-16
Some status are cumulative for all or part of an activity related to its status for the same legal institution. Example: a pharmaceutical establishment may be granted Exploitant status and may be granted manufacturer status limited to batch certification.
Who issues the opening authorisation?
The Public Health Code specifies that the authorisation to open a pharmaceutical establishment is issued by the Director General of the National Agency for the Safety of Medicines and Health Products (ANSM). This opening authorisation is made public on EudraGMP. The start of the activity therefore requires prior authorisation from the ANSM to ensure that the project complies with the regulations and to verify that the necessary resources are available and that they will be implemented. This can be a challenge, for example when early access is about to start, or when a drug is being launched. Indeed, the Exploitant must be designated.
The opinion of the competent central council of the National Order of Pharmacists is required within 2 months for any opening of a pharmaceutical establishment, except for a pharmaceutical establishment dependent on the central pharmacy of the armed forces or the health supply establishments of the armed forces health service. At the end of the 2 months, the Director General of the ANSM can make a decision.
How to compile your file?
For the opening of a pharmaceutical establishment, the ANSM website has 3 types of files available depending on the desired status:
Manufacturer/Importer file
Exploitant’s file
Distributor file
In the event of a combination of activities, as in our example above for example, 2 files must be completed.
The application to be submitted must comply with the decision of 1 October 2019 on the submission of applications for authorisation to open and amend the initial authorisations of the pharmaceutical establishments mentioned in Article R. 5124-2 of the Public Health Code, except for establishments under the authority of the Minister for the Armed Forces (cf. Article R. 5124-5 of PHC).
Such a project includes essential areas of vigilance to carry it out. The constitution of the file requires defining the appropriate status according to the desired activity, anticipating the implementation of the desired organization to write a file that is as compliant as possible with what will be carried out in the future establishment as well as with the regulations in force. The ANSM is particularly attentive to the aspects of pharmaceutical liability, compliance with GxP and security of the premises. Identifying the pharmacist in charge upstream is a crucial point.
What is the processing time?
No pharmaceutical operation may be carried out within the establishment until the authorisation to open has been obtained.
Depending on the desired activity, the applicant submits an application for authorisation to open a site to the ANSM via the dedicated secure platform “Démarches Simplifiées”.
Under the Public Health Code, the Director General of the ANSM is required to notify his decision within 90 days.
Once the file has been submitted by the Responsible Pharmacist in charge of the future establishment via « Démarches Simplifiées », the Responsible Pharmacist receives an email acknowledging receipt of the file.
The admissibility period begins. It lasts for 30 days from the date on which the application is received by ANSM, and allows the content of the application to be analysed: missing documents, incorrect naming of documents, etc. If the ANSM does not receive any requests within 30 days, the application is considered “admissible” and the processing can begin.
The ANSM may ask the applicant for any additional information. The 90-day period is then suspended from the date of notification to the Responsible Pharmacist of the request for additional information by the Director General of the ANSM, until receipt of the information requested.
The ANSM may also carry out an inspection during the processing period to ensure the accuracy of the information provided by the applicant.
If ANSM does not respond within 90 days, this is equivalent to:
refusal of authorisation for manufacturer and importer applications.
tacit authorisation for other establishments.
In recent years, Atessia has opened, modified or relocated more than a dozen pharmaceutical establishments.
This article was written by Isabelle BARBIEUX, Senior Quality Assurance Consultant.
Medical research is essential for the development of new treatments and the improvement of healthcare.
In France, this research is governed by strict regulations designed to protect participants and ensure the integrity of human subjects. The Jardé Law, adopted in March 2012 and enforced since November 2016, is the legal framework for research involving human subjects (RIPH).
It should be noted that clinical trials involving medicinal products are primarily regulated by the EU Clinical Trials Regulation (EU) 536/2014 (CTR), which came into effect on January 31, 2022. This regulation replaces Directive 2001/20/EC. As a reminder, any clinical trial with at least one active investigative site in France as of January 31, 2025, must be transitioned to the Clinical Trials Information System (CTIS) by its sponsor before this date. For clinical trials involving medicinal products, the Jardé Law introduces additional requirements to be considered. Other provisions include compliance with CNIL (GDPR), and procedures related to the use of medicinal products composed wholly or partially of genetically modified organisms (GMOs).
Depending on whether the research concerns a medicinal product or another health product, such as medical devices (clinical investigation) and in vitro diagnostic medical devices (performance study), cell therapy preparations, tissues, organs, labile blood products (LBPs), or even research on dietary supplements or cosmetics, the applicable regulations vary.
What is the Jardé Law?
The Jardé Law, named after Deputy Olivier Jardé, is a regulation that governs the conditions under which research involving human participants can be conducted. It replaces the Huriet-Sérusclat Law of 1988 and aims to enhance the protection of participants while facilitating the conduct of clinical research.
– The Public Health Code (Articles L1121-1 to L1126-11), which details the specific obligations for different categories of research.
Classification of RIPH
Research organized and conducted on human beings with the aim of developing biological or medical knowledge is referred to as “research involving human subjects” (RIPH). There are three types of RIPH:
Category
Legal Provisions
Framework
Category 1 Interventional research involving a risk to participants
Articles L1121-1 and L1121-3 of the Public Health Code (CSP)
These studies require prior authorization from the ANSM (French National Agency for Medicines and Health Products Safety) and a favorable opinion from a Committee for the Protection of Persons (CPP).
Category 2: Interventional research with minimal risks and constraints
Article L1121-2 of the CSP
These studies require a favorable opinion from a CPP, but not authorization from the ANSM.
Category 3: Non-interventional research
Article L1121-1-1 of the CSP
These involve observational studies where the risks are absent or negligible. A favorable opinion from a CPP is necessary, but these studies do not require authorization from the ANSM.
What Are the Implications for the Industry?
Participant Information
The objective of the Jardé Law is to ensure the safety of participants. Special attention is given to the notions of informed consent and clear information.
Manufacturers must ensure that participants fully understand the stakes, procedures, risks, and potential benefits of the study. These requirements are detailed in Articles L1122-1-1 to L1122-2 of the Public Health Code (CSP).
Information for the ANSM
Manufacturers must determine the category of their research during the design phase and ensure they obtain the necessary authorizations. Notably, for RIPH involving medicinal products, they cannot be classified as RIPH 2. An order specifies the criteria to remain within the scope of RIPH 2. For category 1 RIPH, this involves submitting a complete dossier to the ANSM and obtaining a favorable opinion from a CPP (Article L1121-4 of the CSP). Since 2022, for clinical trials on medicinal products, the CTR requires submission through the CTIS platform. Proper classification of your RIPH is a prerequisite for any procedure.
Interactions with CPPs and the ANSM
CPPs are French ethics committees. Interactions with CPPs and the ANSM are essential for the validation of research projects. Good communication and submission of complete dossiers are necessary, in accordance with Articles L1123-6 and L1123-7 of the Public Health Code.
Procedures
Before submitting the authorization request dossier (initial authorization and substantial modification) and/or human research opinion request, or routine care research, sponsors must obtain an IDRCB registration number for the research. This number identifies each research conducted in France. For a biomedical research authorization and opinion request concerning a medicinal product for human use, sponsors must obtain a research registration number in the European CTIS database (formerly: EudraCT).
Subsequently, sponsors will electronically submit the biomedical research authorization and/or opinion request dossier to the ANSM and/or CPP, in accordance with the current orders setting the dossier formats for each type of research. Various “Notices to Sponsors” guide these procedures according to the situation.
Conclusion
The Jardé Law thus ensures the safety of participants in clinical research in France.
For health manufacturers, understanding and complying with these regulations is not only a legal obligation but also a guarantee of the quality of the data generated, particularly for use in a Marketing Authorization Application (MAA) dossier.
By integrating the requirements of the Jardé Law into their processes, manufacturers contribute to the development of innovative treatments while ensuring high ethical standards, in accordance with French regulations on this matter.
Atessia can assist you in implementing these processes with its expertise in clinical trials.
In a constantly evolving pharmaceutical industrial environment, regulatory requirements for quality data are becoming increasingly complex. Health authorities are continually updating guidelines, increasing CMC demands on regulatory affairs professionals. Faced with this complexity, revising the operational model and utilizing external expertise are essential solutions to overcome these challenges and meet market demands.
Why Outsource CMC Activities?
Increasing Regulatory Requirements Health authorities are continuously raising the quality standards from development to drug registration and throughout the lifecycle of marketing authorizations (MA**). This trend imposes a significant workload from a CMC perspective, necessitating rigorous and expert management of regulatory dossiers.
Impact of Mergers and Acquisitions Corporate mergers and acquisitions increase the number of regulatory submissions to reflect changes in supply sources, production site transfers, etc. This dynamic requires increased flexibility and responsiveness to maintain compliance and the continuity of pharmaceutical operations.
Resource Management Optimization Increasingly complex regulatory requirements necessitate deep knowledge, leading to increased personnel needs and creating a talent shortage. The traditional operational model of pharmaceutical laboratories is often no longer optimized to handle the surplus work related to these CMC activities. Outsourcing complex technical and regulatory aspects reduces workload and improves overall efficiency.
ATESSIA’s Unique Expertise
ATESSIA was founded by Géraldine Baudot-Visser, a recognized expert in the technical-regulatory field. With a doctorate in pharmacy, extensive experience in R&D and regulatory affairs, Géraldine created ATESSIA to offer an innovative and client-centered approach. Her solid CMC expertise, acquired within major pharmaceutical laboratories and consulting firms, is at the heart of the service offering.
Why Choose ATESSIA for Your CMC Needs?
Cutting-Edge Expertise and Knowledge ATESSIA has multidisciplinary expert teams with in-depth CMC knowledge. Our consultants possess practical experience and a fine understanding of regulatory authorities’ expectations, ensuring the quality of dossiers and compliance with current requirements.
Cost Reduction and Time Savings ATESSIA has the expertise to efficiently manage CMC activities and offers economical and fast solutions, best adapting to the market entry deadlines desired by its clients.
Guaranteed Quality Structured around the ISO 9001 standard, ATESSIA ensures impeccable quality at every stage of the product lifecycle.
Partner for Your R&D Activities ATESSIA has Research Tax Credit approval, enabling you to be supported in your research and development activities.
Our Commitment to Excellence and Innovation
At ATESSIA, we stand out with our agile and tailored approach, integrating feedback and specific needs of each client. Our flexibility and ability to integrate new technologies allow us to offer innovative solutions adapted to evolving market demands.
Choosing ATESSIA for your CMC needs ensures expert and personalized support, capable of transforming your regulatory challenges into successes. Our commitment to excellence and innovation guarantees optimal results that ensure your competitiveness in the market.
To learn more about our CMC services and other regulatory and pharmaceutical affairs offerings, and to discover how we can support you, contact us today.