The Legal Status of the "Pharmacien Responsable" a Key Figure in the French Pharmaceutical Industry
The Legal Status of the "Pharmacien Responsable" a Key Figure in the French Pharmaceutical Industry
The Responsible Pharmacist (Pharmacien Responsable) is a cornerstone in the management of French pharmaceuticals companies. He ensures compliance with the French Public Health Code (Code de la Santé Publique – CSP) and, more generally, ensures the drugs safety. He has a peculiar and unique position, endowed with broader responsibilities compared to his European peers known as “Qualified Persons” as defined under the European Directive (Directive 2001/83/EC, Article 48 & Volume IX).
Having a significant experience in the healthcare sector, BDO Avocats assists national and international pharmaceutical groups and companies in their set up and operations in France. In this context, the terms and conditions of the appointment and the role of the Pharmacien Responsable are frequently asked questions, that leads us to take stock on this cornerstone of the French pharmaceutical industry.
When Should You Appoint a Pharmacien Responsable?
Pursuant to Article L.5124-2 CSP, any company operating a pharmaceutical establishment engaged in activities such as purchasing, manufacturing, marketing, importing or exporting, and wholesale distribution of pharmaceutical products must be owned by a pharmacist or managed by a company which management or general direction includes a Pharmacien Responsable.
Therefore, the appointment of a Pharmacien Responsable is a prerequisite for any administrative authorization request to operate a pharmaceutical establishment, as issued by the National Agency for the Safety of Medicines and health products (Agence Nationale de Sécurité du Médicament et des Produits de Santé - ANSM).
💡 TO KEEP IN MIND: The pharmaceutical establishment must provide a copy of the act appointing the Pharmacien Responsible and outlining their responsibilities, to both the Director of the ANSM and the relevant Central Council of the Ordre National des Pharmaciens (National Order of Pharmacists).
In addition to appointing a Pharmacien Responsable, and given their crucial role in safeguarding public health, the company must also appoint one or more interim pharmacists to replace the Pharmacien Responsable in the event of temporary absence or prohibition on practice. These interim pharmacists are not required to hold an executive mandate within the company.
In cases where a pharmaceutical company operates multiple establishments, a delegated pharmacist (pharmacien délégué) must be appointed for each establishment to assist the Pharmacien Responsable.
💡 NOTE: If the Pharmacien Responsable performs his duties directly within a pharmaceutical establishment, there is no necessity to appoint a delegated pharmacist for that establishment.
In pharmaceutical companies managing many establishments, assistant pharmacists may be appointed to support the Pharmaciens Responsables or delegated pharmacists in performing specific pharmaceutical operations.
What Is the Status and Role of the Pharmacien Responsable?
The Pharmacien Responsable is defined under Article R.5124-34 of the CSP. He should be a pharmacist and either the owner of the company or having an executive mandate within the he works with.
Among the responsibilities granted under Article R.5124-36 of the CSP, the Pharmacien Responsable shall take part in the deliberations of managing, administrative, executive, or supervisory bodies whenever these decisions pertain to or may impact the execution of their professional duties.
Any breach of these obligations is punishable by up to two years’ imprisonment and a fine of €150,000, as stipulated in Article L.5423-1 of the CSP. Additionally, temporary or permanent administrative closure of the establishment may be ordered.
The corporate mandate of the Pharmacien Responsable depends on the legal structure of the company in which he operates:
💡 GOOD TO KNOW: In SAS companies —commonly used corporate structure—the Pharmacien Responsible can be appointed either as President or General Manager. If appointed as General Manager, given the statutory flexibility that characterizes the SAS, the company's bylaws must be carefully drafted to clearly define the scope of its powers as a corporate officer.
The Pharmacien Responsible is entrusted with diverse responsibilities related to the activities of the establishment in which he operates.
He must be able to personally perform his professional duties. All pharmaceutical actions are carried out under the effective control of the Pharmacien Responsable, who remains accountable for the quality of operations conducted under their supervision.
💡 KEY POINT: In each pharmaceutical establishment of the company, a delegated pharmacist ensures compliance with legal provisions under the authority of the company’s Pharmacien Responsable. The Pharmacien Responsable has authority over the delegated pharmacists, approves their appointment (same applies to interim pharmacists), and is consulted regarding their departure.
The Pharmacien Responsible primarily organizes and oversees all pharmaceutical operations (manufacturing, advertising, information dissemination, batch monitoring and recalls) and ensures that transportation conditions guarantee the proper preservation, integrity, and safety of products and he may also take part developping research and study programs.
💡 DO NOT FORGET: The Pharmacien Responsible may be required to report to the ANSM any instance of a counterfeit medicine entering the national market, which they oversee in terms of manufacturing, exploitation, or distribution. These reports must, of course, not be abusive (e.g., misuse of dominant position or anti-competitive practices).
They are also responsible for signing, after a first review of the documentation, Marketing Authorization Applications (AMM) and any other requests related to the activities they organize and supervise.
💡 ESSENTIAL REQUIREMENT: As the Pharmacien Responsable must personally perform his professional tasks and closely monitor their execution if not carried out directly by them, they cannot work part-time if the company operates full-time. This obligation of personal involvement also precludes them from simultaneously managing a retail pharmacy or serving as the manager of a mutual pharmacy, as these roles are incompatible with the responsibilities of a Pharmacien Responsable.
What is the extent of the Pharmacien Responsable’s liability?
The Pharmacien Responsable is personally responsible for compliance with provisions related to his activities, without prejudice to the potential joint liability of the company in which he operates.
For example, in the event of a disagreement with a management body regarding the application of regulations, it is the responsibility of the Pharmacien Responsable, in the public health interest, to inform the General Director of the ANSM. If they fail to provide this information, they can be personally accountable in case the company's leaders disregard their observations. Thus, their civil liability may be incurred, even though in practice, legal actions tend to target the company, which is generally more solvent.
The Pharmacien Responsible also faces criminal prosecution in case of violations of the French Code de la Santé Public that he committed or failed to prevent. For instance, a criminal court has condemned a Pharmacien Responsible for improper maintenance of premises and insufficient equipment, as well as the delegated pharmacist who failed to adequately oversee the competence and activities of the autoclave operator. Delegating authority was not sufficient to absolve them of their responsibility.
Finally, the Pharmacien Responsible risks disciplinary sanctions, for example, in the case of marketing pharmaceutical products without a market authorization.
Worst-case scenario, the Pharmacien Responsable may be struck off the register.
Who can be appointed as Pharmacien Responsable?
The Pharmacien Responsable must have state diploma of Doctor in Pharmacy or Pharmacist (or a certificate/other European title), be of French nationality (or an Andorran citizen/a national of a European Union member state or a state party to the European Economic Area (EEA) agreement /a national of a country where French citizens can practice pharmacy with the appropriate qualifications), be registered with the National Order of Pharmacists, and complete their registration with the Order.
💡 KEY POINT: The diploma of the Pharmacien Responsible can only be registered for one company or organization.
The future Pharmacien Responsable must also demonstrate a minimum of two years of practical experience gained in one or more establishments authorized to manufacture or import medicines or products in an EU member state or a country party to the EEA agreement.
💡 TO KEEP IN MIND: The usual practical experience duration of two years is reduced to six months for pharmacists who have completed at least six years of studies, which is most common in practice.
💡 SPECIFIC FEATURES: There are specific exceptions to the required experience, depending on the type of activity of the establishment: within companies engaged in the exploitation of medicines other than experimental medicines, in military central pharmacy establishments, in pharmaceutical establishments created within public or non-profit organizations, or in pharmaceutical establishments involved in the manufacturing and distribution of innovative therapy medicines.
If the required practical experience is not met, registration with the Order of Pharmacists will be denied.
Appointment and Dismissal of the Pharmacien Responsible
Appointment: The Pharmacien Responsable is appointed by the corporate body responsible for appointing a corporate officer. In the case of an SAS, it is important to specify which body is competent to appoint them in the company’s bylaws.
💡 GOOD TO KNOW: To ensure the enforceability of its corporate mandate (manager, managing director, president, etc.) it must be published with the French Trade and Companies Register and must be mentioned on the company’s Kbis extract (certificate of registration of the company).
The appointment of a Pharmacien Responsable must also be reported to the ANSM and the National Order of Pharmacists.
Dismissal: The conditions for the dismissal of the Pharmacien Responsable pertains to the corporate structure of the company and, where applicable, the bylaws or the decision appointing him as corporate officer.
As with any executive, the dismissal of the Pharmacien Responsable under abusive or vexatious conditions may entitle them to compensation.
If the duties of a Pharmacien Responsable are terminated, or if their mandate is not renewed upon expiration, the individual may appeal to the Central Council of the relevant section of the National Order of Pharmacists.
The Council, after a contradictory examination, will issue an opinion on whether the individual failed to meet their obligations in the interest of public health as Pharmacien Responsable.
💡 NOTE: This opinion, which is purely advisory, does not bind the judges but may be presented to help them assess the abusive nature of the termination of office.
Resignation: The Pharmacien Responsable may also resign from his mandate, according to the conditions set out in the bylaws. If the bylaws do not specify anyhting, the Pharmacien Responsable must respect a reasonable notice period.
Cumulative Roles of Pharmacien Responsable with Other Functions
Thus, it is impossible to combine the role of Pharmacien Responsable with running a pharmacy or managing a mutual pharmacy (Article R.5124-32 CSP), except under the exemptions provided in Article R.5124-33 CSP).
He can only serve one company or organization.
Similarly, he is prohibited from being an assistant pharmacist at another pharmaceutical establishment, even if both roles are part-time and the schedules do not overlap.
It is possible to combine a corporate mandate as Pharmacien Responsable with an employment contract. However, this combination is subject to strict conditions and could incur potential risks.
The employment contract shall consist in effective work distinct from the responsibilities of the Pharmacien Responsable corporate mandate and should incur specific compensation. Moreover, a genuine subordinate relationship must exist between the company and the individual.
Combining the corporate mandate of Pharmacien Responsable with an employment contract can sometimes lead to legal disputes.
In practice, these disputes arise, for example, after a dismissal, a resignation from his corporate mandate, or a termination of the employment contract initiated by the employee due to the employer's fault (taking note of - “prise d’acte”, or judicial termination – “résiliation judiciaire”). In such cases, the Pharmacien Responsable may seek to have the judges qualify their employment contract as being suspended during the term of the combined corporate mandate, allowing them to remain within the company after their dismissal.
💡 TO KEEP IN MIND: When the Pharmacien Responsable holds both a corporate mandate and an employment contract, you will need to handle the termination of the employment contract and the corporate mandate separately at time of termination of the corporate duties, following the respective procedures of labor law (for the employment contract) and commercial law and statutory provisions (for the corporate mandate).
***
Appointing a Pharmacien Responsable is a matter that often requires expert support in health, corporate, and labor law to ensure the company complies with applicable legal and regulatory provisions.
At BDO Avocats, we leverage our diverse expertise to support companies in the pharmaceutical sector. Feel free to contact us following this link: BDO Avocats Contact.
Having a significant experience in the healthcare sector, BDO Avocats assists national and international pharmaceutical groups and companies in their set up and operations in France. In this context, the terms and conditions of the appointment and the role of the Pharmacien Responsable are frequently asked questions, that leads us to take stock on this cornerstone of the French pharmaceutical industry.
When Should You Appoint a Pharmacien Responsable?
Pursuant to Article L.5124-2 CSP, any company operating a pharmaceutical establishment engaged in activities such as purchasing, manufacturing, marketing, importing or exporting, and wholesale distribution of pharmaceutical products must be owned by a pharmacist or managed by a company which management or general direction includes a Pharmacien Responsable.
Therefore, the appointment of a Pharmacien Responsable is a prerequisite for any administrative authorization request to operate a pharmaceutical establishment, as issued by the National Agency for the Safety of Medicines and health products (Agence Nationale de Sécurité du Médicament et des Produits de Santé - ANSM).
💡 TO KEEP IN MIND: The pharmaceutical establishment must provide a copy of the act appointing the Pharmacien Responsible and outlining their responsibilities, to both the Director of the ANSM and the relevant Central Council of the Ordre National des Pharmaciens (National Order of Pharmacists).
In addition to appointing a Pharmacien Responsable, and given their crucial role in safeguarding public health, the company must also appoint one or more interim pharmacists to replace the Pharmacien Responsable in the event of temporary absence or prohibition on practice. These interim pharmacists are not required to hold an executive mandate within the company.
In cases where a pharmaceutical company operates multiple establishments, a delegated pharmacist (pharmacien délégué) must be appointed for each establishment to assist the Pharmacien Responsable.
💡 NOTE: If the Pharmacien Responsable performs his duties directly within a pharmaceutical establishment, there is no necessity to appoint a delegated pharmacist for that establishment.
In pharmaceutical companies managing many establishments, assistant pharmacists may be appointed to support the Pharmaciens Responsables or delegated pharmacists in performing specific pharmaceutical operations.
What Is the Status and Role of the Pharmacien Responsable?
The Pharmacien Responsable is defined under Article R.5124-34 of the CSP. He should be a pharmacist and either the owner of the company or having an executive mandate within the he works with.
Among the responsibilities granted under Article R.5124-36 of the CSP, the Pharmacien Responsable shall take part in the deliberations of managing, administrative, executive, or supervisory bodies whenever these decisions pertain to or may impact the execution of their professional duties.
Any breach of these obligations is punishable by up to two years’ imprisonment and a fine of €150,000, as stipulated in Article L.5423-1 of the CSP. Additionally, temporary or permanent administrative closure of the establishment may be ordered.
The corporate mandate of the Pharmacien Responsable depends on the legal structure of the company in which he operates:
| Corporate Structure | Corporate Mandate |
| Public Limited Companies (SA) - Traditional type with a Board of Directors and Managing Director | Chairman of the Board of Directors with the title of Managing Director, Managing Director, or Deputy Managing Director |
| Public Limited Companies (SA) - Dualistic type with Management Board and Supervisory Board | Chairman of the Management Board, another member of the Management Board with the title of Managing Director, or sole Managing Director |
| Partnership Limited by Shares, Limited Liability Company (LLC), Sole Proprietorship LLC, General Partnership, Limited Partnership | Manager |
| Simplified Joint-Stock Companies (SAS) | Chairman of the company or Managing Director appointed by the bylaws |
💡 GOOD TO KNOW: In SAS companies —commonly used corporate structure—the Pharmacien Responsible can be appointed either as President or General Manager. If appointed as General Manager, given the statutory flexibility that characterizes the SAS, the company's bylaws must be carefully drafted to clearly define the scope of its powers as a corporate officer.
The Pharmacien Responsible is entrusted with diverse responsibilities related to the activities of the establishment in which he operates.
He must be able to personally perform his professional duties. All pharmaceutical actions are carried out under the effective control of the Pharmacien Responsable, who remains accountable for the quality of operations conducted under their supervision.
💡 KEY POINT: In each pharmaceutical establishment of the company, a delegated pharmacist ensures compliance with legal provisions under the authority of the company’s Pharmacien Responsable. The Pharmacien Responsable has authority over the delegated pharmacists, approves their appointment (same applies to interim pharmacists), and is consulted regarding their departure.
The Pharmacien Responsible primarily organizes and oversees all pharmaceutical operations (manufacturing, advertising, information dissemination, batch monitoring and recalls) and ensures that transportation conditions guarantee the proper preservation, integrity, and safety of products and he may also take part developping research and study programs.
💡 DO NOT FORGET: The Pharmacien Responsible may be required to report to the ANSM any instance of a counterfeit medicine entering the national market, which they oversee in terms of manufacturing, exploitation, or distribution. These reports must, of course, not be abusive (e.g., misuse of dominant position or anti-competitive practices).
They are also responsible for signing, after a first review of the documentation, Marketing Authorization Applications (AMM) and any other requests related to the activities they organize and supervise.
💡 ESSENTIAL REQUIREMENT: As the Pharmacien Responsable must personally perform his professional tasks and closely monitor their execution if not carried out directly by them, they cannot work part-time if the company operates full-time. This obligation of personal involvement also precludes them from simultaneously managing a retail pharmacy or serving as the manager of a mutual pharmacy, as these roles are incompatible with the responsibilities of a Pharmacien Responsable.
What is the extent of the Pharmacien Responsable’s liability?
The Pharmacien Responsable is personally responsible for compliance with provisions related to his activities, without prejudice to the potential joint liability of the company in which he operates.
For example, in the event of a disagreement with a management body regarding the application of regulations, it is the responsibility of the Pharmacien Responsable, in the public health interest, to inform the General Director of the ANSM. If they fail to provide this information, they can be personally accountable in case the company's leaders disregard their observations. Thus, their civil liability may be incurred, even though in practice, legal actions tend to target the company, which is generally more solvent.
The Pharmacien Responsible also faces criminal prosecution in case of violations of the French Code de la Santé Public that he committed or failed to prevent. For instance, a criminal court has condemned a Pharmacien Responsible for improper maintenance of premises and insufficient equipment, as well as the delegated pharmacist who failed to adequately oversee the competence and activities of the autoclave operator. Delegating authority was not sufficient to absolve them of their responsibility.
Finally, the Pharmacien Responsible risks disciplinary sanctions, for example, in the case of marketing pharmaceutical products without a market authorization.
Worst-case scenario, the Pharmacien Responsable may be struck off the register.
Who can be appointed as Pharmacien Responsable?
The Pharmacien Responsable must have state diploma of Doctor in Pharmacy or Pharmacist (or a certificate/other European title), be of French nationality (or an Andorran citizen/a national of a European Union member state or a state party to the European Economic Area (EEA) agreement /a national of a country where French citizens can practice pharmacy with the appropriate qualifications), be registered with the National Order of Pharmacists, and complete their registration with the Order.
💡 KEY POINT: The diploma of the Pharmacien Responsible can only be registered for one company or organization.
The future Pharmacien Responsable must also demonstrate a minimum of two years of practical experience gained in one or more establishments authorized to manufacture or import medicines or products in an EU member state or a country party to the EEA agreement.
💡 TO KEEP IN MIND: The usual practical experience duration of two years is reduced to six months for pharmacists who have completed at least six years of studies, which is most common in practice.
💡 SPECIFIC FEATURES: There are specific exceptions to the required experience, depending on the type of activity of the establishment: within companies engaged in the exploitation of medicines other than experimental medicines, in military central pharmacy establishments, in pharmaceutical establishments created within public or non-profit organizations, or in pharmaceutical establishments involved in the manufacturing and distribution of innovative therapy medicines.
If the required practical experience is not met, registration with the Order of Pharmacists will be denied.
Appointment and Dismissal of the Pharmacien Responsible
Appointment: The Pharmacien Responsable is appointed by the corporate body responsible for appointing a corporate officer. In the case of an SAS, it is important to specify which body is competent to appoint them in the company’s bylaws.
💡 GOOD TO KNOW: To ensure the enforceability of its corporate mandate (manager, managing director, president, etc.) it must be published with the French Trade and Companies Register and must be mentioned on the company’s Kbis extract (certificate of registration of the company).
The appointment of a Pharmacien Responsable must also be reported to the ANSM and the National Order of Pharmacists.
Dismissal: The conditions for the dismissal of the Pharmacien Responsable pertains to the corporate structure of the company and, where applicable, the bylaws or the decision appointing him as corporate officer.
As with any executive, the dismissal of the Pharmacien Responsable under abusive or vexatious conditions may entitle them to compensation.
If the duties of a Pharmacien Responsable are terminated, or if their mandate is not renewed upon expiration, the individual may appeal to the Central Council of the relevant section of the National Order of Pharmacists.
The Council, after a contradictory examination, will issue an opinion on whether the individual failed to meet their obligations in the interest of public health as Pharmacien Responsable.
💡 NOTE: This opinion, which is purely advisory, does not bind the judges but may be presented to help them assess the abusive nature of the termination of office.
Resignation: The Pharmacien Responsable may also resign from his mandate, according to the conditions set out in the bylaws. If the bylaws do not specify anyhting, the Pharmacien Responsable must respect a reasonable notice period.
Cumulative Roles of Pharmacien Responsable with Other Functions
- Prohibition of cumulate duties as Pharmacien Responsable with Comparable Roles in Other Pharmaceutical Establishments
Thus, it is impossible to combine the role of Pharmacien Responsable with running a pharmacy or managing a mutual pharmacy (Article R.5124-32 CSP), except under the exemptions provided in Article R.5124-33 CSP).
He can only serve one company or organization.
Similarly, he is prohibited from being an assistant pharmacist at another pharmaceutical establishment, even if both roles are part-time and the schedules do not overlap.
- Possibility of Combining the Role of Corporate Officer with an Employment Contract
It is possible to combine a corporate mandate as Pharmacien Responsable with an employment contract. However, this combination is subject to strict conditions and could incur potential risks.
The employment contract shall consist in effective work distinct from the responsibilities of the Pharmacien Responsable corporate mandate and should incur specific compensation. Moreover, a genuine subordinate relationship must exist between the company and the individual.
Combining the corporate mandate of Pharmacien Responsable with an employment contract can sometimes lead to legal disputes.
In practice, these disputes arise, for example, after a dismissal, a resignation from his corporate mandate, or a termination of the employment contract initiated by the employee due to the employer's fault (taking note of - “prise d’acte”, or judicial termination – “résiliation judiciaire”). In such cases, the Pharmacien Responsable may seek to have the judges qualify their employment contract as being suspended during the term of the combined corporate mandate, allowing them to remain within the company after their dismissal.
💡 TO KEEP IN MIND: When the Pharmacien Responsable holds both a corporate mandate and an employment contract, you will need to handle the termination of the employment contract and the corporate mandate separately at time of termination of the corporate duties, following the respective procedures of labor law (for the employment contract) and commercial law and statutory provisions (for the corporate mandate).
***
Appointing a Pharmacien Responsable is a matter that often requires expert support in health, corporate, and labor law to ensure the company complies with applicable legal and regulatory provisions.
At BDO Avocats, we leverage our diverse expertise to support companies in the pharmaceutical sector. Feel free to contact us following this link: BDO Avocats Contact.