The Importance of the Exploitant Role
In France, no medicinal product can be marketed or distributed – whether under a Marketing Authorization (MA) or through an Early or Compassionate Access Program – without a licensed Exploitant assuming full regulatory responsibility (article R. 5124-2 of the Health Public Code).
Discover Aphilæ’s full Exploitant solution
At Aphilæ Pharma, we act as your local regulatory and commercial partner, ensuring that your products enter the French market safely, compliantly, and efficiently.
Every Exploitant operates under the supervision of a Responsible Pharmacist (RP) – a uniquely French role defined by Articles R.5124-16 to R.5124-41 of the Public Health Code.
This professional ensures the highest standards of quality, patient safety, and compliance across all pharmaceutical activities, including:
- Manufacturing oversight and batch release
- Advertising and promotional review
- Medical information and pharmacovigilance
- Product follow-up, recall, and quality management
- Distribution, import/export, storage, and logistics
The Responsible Pharmacist holds broader and more integrated duties than the EU Qualified Person (QP).
They carry personal accountability for compliance with all French pharmaceutical regulations – guaranteeing that your operations meet both regulatory and ethical standards at every stage.
Aphilæ Pharma is your gateway to the French market, ensuring full compliance and patient protection while you focus on innovation and growth.
Foreign companies
Are you a foreign company looking to enter the French market?
You can rely on Aphilæ Pharma’s established infrastructure to manage:
- Licensed products
- Compassionate access programs
- Early access programs (AP1, AP2)
Our Activities as an Exploitant
- Wholesaling
- Promotional activities
- Medical information
- Pharmacovigilance
- Batch follow-up and, if necessary, batch recall
- Storage
In addition, the Exploitant plays a crucial role in Market Access, Sales Reps Certification, and pharmaceutical taxes. Our expertise will help you navigate these complexities.