- 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 CPO is required in all pharmaceutical companies in France, irrespective of their activities.
- The role is defined in Art R. 5124-36 of the Public Health Code, as:
The CPO organizes and oversees all the pharmaceutical operations of the company or organization, particularly 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 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). Her/his personal responsibility is engaged as a guarantor of the quality of the medication and the safety of the patients.
- At least one deputy-CPO must be appointed to guarantee the continuity of the pharmaceutical responsibility during the absence of the CPO.
