Role of Responsible Pharmacists in France

Known as “Pharmacien Responsable” or Chief Pharmaceutical Officer, a Responsible Pharmacist in France has to hold a diploma of doctor in pharmacy and to meet the practice conditions such as:

 

  • Responsible pharmacist must justify of a certain professional experience, notably in batch monitoring activities associated with pharmacovigilance activities (from 6 months to 2 years).
  • Responsible Pharmacist must be registered within the French Order of Pharmacists and to have his/her diploma registered for a single company. The company must notify the general manager of the French Health Authority (ANSM) of the appointment of a new Responsible Pharmacist within one month.

Why having a responsible pharmacist is mandatory for pharmaceutical companies in France?

French Public Health Code specifies that “any company that includes at least one pharmaceutical establishment must be owned by a pharmacist or a company in which a pharmacist participates to the management or general direction […]”.

 

These mentioned pharmacists are called “Responsible Pharmacists” or “Chief Pharmaceutical Officer”.

 

Reminder: In order to market drugs on French market, pharmaceutical companies must have an affiliate “Exploitant” or a partner Exploitant.

 

Learn more about Exploitant activities here

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About the Chief Pharmaceutical Officer – Responsible Pharmacist

 

  • French law places pharmaceutical responsibility in the hands of a named person, the Chief Pharmaceutical Officer –CPO (“Pharmacien Responsable”).
  • This status is specific to France and derives directly from the pharmaceutical monopoly.
  • The presence of a Responsible Pharmacist is required in all pharmaceutical companies in France, irrespective of their activities.

 

 

Responsible Pharmacist role is defined in Art R.5124-36 of the Public Health Code, as:

 

  • The Responsible Pharmacist (CPO) organizes and oversees all the pharmaceutical operations of the company or organization, particularly drugs manufacturing, advertising, information, pharmacovigilance, batch tracking and recall, the distribution, importing and exporting of medicinal products, devices, objects or related items as well as the corresponding storage operations […].”
  • The CPO responsibilities are broader than those of the “Qualified person” defined at European level.
  • The CPO is a corporate officer, who organizes and oversees safe and effective running of all pharmaceutical activities. Its unique position in the company makes it the privileged interlocutor of the health authorities. He is a senior member of the company with a status of General Manager (Art R.5124-34 and Art R.5124-36), personally practicing his profession (Art. L 5124-2) and he has an experience appropriate practice (Art. R.5124-16).
  • The concept of responsibility is very important, and it is important that it be visible in a company organization chart with mention of the hierarchical links and delegations: Pharmacist Manager, Interim Lead Pharmacist in the absence of the Chief Pharmacist, Assistant Pharmacists and Delegates. It is his personal responsibility that is engaged as a guarantor of the quality of the medication and the safety of the patients.

Supervision of promotional activities

The Responsible Pharmacist takes on many tasks, as mentioned in Article R.5124-36 of the CSP, since he/she “organizes and supervises all pharmaceutical operations of the company or organization, and in particular manufacturing, advertising, information […] as well as the corresponding storage operations”.

 

The Responsible Pharmacist is thus responsible for the promotional nature of all information relating to medicinal products. Indeed, according to Article R.4235-69 of the French Public Health Code, “the Responsible Pharmacist is required to ensure the accuracy of scientific, medical, and pharmaceutical information and advertising, as well as the fairness of their use.

 

He shall ensure that advertising of medicinal products is objective and not misleading”. He is the guarantor of the ethics of the information; thus he/she must notably refrain discrediting a colleague or a competitor (particular attention should be paid to comparative advertising).

Article R.5124-36 of the CSP also notably stipulates that the Responsible Pharmacist “signs, after having taken notice of the file, […] any application related to the activities he/she organizes and supervises”. Therefore, regarding advertising, which is considered as a pharmaceutical operation, the Responsible Pharmacist must sign promotional materials as well as visa applications files to the French Health Authority (ANSM), as his own responsibility is engaged.

 

Moreover, in accordance with the Promotional Information Charter dated 2014 and its current requirements, the Responsible Pharmacist is responsible for the content of promotional materials as well as for the associated medical sales representative’s speech. He/she shall maintain lists of materials that can and should be delivered and shall ensure that the person carrying out an information activity by canvassing or prospecting has the required knowledge for the exercise of his/her profession and that he/she receives regular continuous training aimed at updating his/her knowledge.

Responsible pharmacist regulations and liability

Finally, the Responsible Pharmacist is legally liable (article L.5422 of the CSP).

 

Disciplinary sanctions may apply if he/she fails to fulfill his/her duties (this can be from a warning to permanent withdrawal of authorization to practice and loss of their diploma). The Responsible Pharmacist also incurs civil and criminal liability.

 

For example, to disseminate a promotional document for a medicinal product that has not been granted a marketing authorization, or to disseminate a promotional document for a medicinal product without a visa delivered by ANSM, may be punished by imprisonment and financial penalties (articles L.5421-2 and L.5422-6 of the CSP). a healthcare professional who understands pharmaceutical medicines and how they can fight diseases and improve their health.

 

Pharmacy professionals work to improve patients’ lives by delivering individualized medication therapy. Examples include cures and prevention of illness, reduction of symptoms, or elimination of symptomatic diseases.

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How can BlueReg help you comply with French regulatory requirements?

You are a foreign company planning to find a partner in France

 

As an established pharma organization outside France or Europe, a company contemplates launching an orphan drug in France but have no affiliate to proceed further. How and why BlueReg could be the right solution for the company?

 

  • Bluereg has built a robust quality management system to provide continuous and specific support to foreign companies willing to introduce new products to the French market.
  • Pharma Blue (BlueReg French affiliate) with the support of its mother company BlueReg offers the possibility to hold the Exploitant status and overlook pharmaceutical operations on the French Market with a Responsible Pharmacist.
  • Pharma Blue has an experienced team in quality management and pharmacovigilance that is used to cooperate with firms in Europe and in the US.

You are a pharmaceutical company considering establishing an affiliate in France

 

You have a plan to create an affiliate in France, how could BlueReg be of help in this project?

 

BlueReg can provide support to your plan of creation of a licensed pharmaceutical affiliate in France (with an Exploitant status) with a framework of progressive disengagement as your new business gets more resources and staffing (Responsible Pharmacist temporary allocation).

 

BlueReg experts’ team will be able to support your affiliate obtaining the licensed Exploitant status and extend support and training to newly formed organization to ensure a smooth transfer of competency.

Associated services

Launch Activities

Clients rely on BlueReg’s regulatory intelligence as well as the experience and expertise of our consultants and partner network for the success of their projects. BlueReg can provide an end-to-end project plan to guide you through the regulatory preparation of the commercial product launch.

Associated services

Promotional Material Review

BlueReg is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.

Associated services

Pricing and reimbursement (Drugs and Medical devices)

BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).

Associated services

Quality System and Audit

BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.

 

Associated services

Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).

Case study

Temporary Authorisation for Use (ATU) in France

A French pharmaceutical affiliate entrusted BlueReg to support them for the whole process of submission (advice, writing activities and support...

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