Pharmacovigilance Data Protection Policy

Data protection

Skyepharma Production SAS, as the data controller, is committed to processing your personal health data in accordance with the French Data Protection Act (“Informatique et Libertés”), the EU General Data Protection Regulation (GDPR 2016/679), and the French Public Health Code.

1. Data Collected

In the context of pharmacovigilance, personal data that may be collected include: first name, last name, gender, date of birth, email, phone, and health-related data.
These data are used exclusively for pharmacovigilance purposes, i.e., for the monitoring, evaluation, prevention, and management of the risk of adverse effects resulting from the use of a medicinal product.

2. Recipients

Collected data are used only for health vigilance purposes and may be processed by:

  • The Pharmacovigilance Department of Skyepharma Production SAS

  • Subcontracted experts in the field, under contracts ensuring data protection

  • National or international health authorities in charge of pharmacovigilance, in a pseudonymized form, such as:

    • Haute Autorité de Santé (HAS)

    • Ministry of Health and Social Security

    • Agence Nationale de Sécurité du Médicament (ANSM)

    • European Medicines Agency (EMA)

    • Regional pharmacovigilance centers

3. Method and Duration of Storage

During pharmacovigilance management, your data are stored electronically and securely, then archived for ten years from the expiry of the relevant marketing authorization (MA).
After processing the reported adverse event, indirectly identifying data of the exposed individual are stored in the international pharmacovigilance database for seventy years from the withdrawal date of the concerned medicine.

4. Rights Regarding Your Personal Data

You may exercise your rights of access, correction, and restriction of personal data at any time by contacting us via email: privacy@skyepharma.com

Since processing is based on a legal obligation, you do not have the rights to erasure, opposition, or data portability.

If you believe that your rights are not being respected, you may file a complaint with the French Data Protection Authority (CNIL).