PharmaBlue, a BlueReg Company. PharmaBlue is part of the BlueReg family, an integrated service within the global consulting group, and a partner “Exploitant” of innovative Pharma Companies for the marketing in France of their medicinal products.

As mentioned earlier, the exploitation is ensured either by the holder of the marketing authorization mentioned in article L. 5121-8, of the temporary authorization of use mentioned in 1 ° of I of the article L. 5121-12 or one of the registrations mentioned in Articles L. 5121-13 and L. 5121-14-1, that is, on behalf of this holder, by another company or another organization, or by one and the other, each providing in this case one or more categories of operations constituting the exploitation of the drug or product. The definition and control of pharmaceutical responsibilities between each stakeholder is via a contract and specifications.

In Article R. 5124-2 3° of the Public Health Code, Exploitant is understood to mean: “The company or organization providing the exploitation of medicinal products […]

The Exploitant operations includes :

• Wholesaling or free distribution;
• Advertising ;
• Medical information;
• Pharmacovigilance: the obligations of the operator are mentioned in articles 5121-162 to R. R. 5121-177 of the CSP, from which it emerges an obligation of surveillance and proactivity of the operator with regard to the pharmacovigilance of the medicines he places on the French market;
• Monitoring of lots and, where appropriate, their withdrawal and, where appropriate, the corresponding storage operations.

The Exploitant is accountable for the quality of the medicinal product placed on the French market and, in light of these obligations, must maintain close relations with key stakeholders (manufacturer and distributor).

• 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).

• 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.