Health vigilance systems (incl. for pharmacoviogilance and productvigilance) are covered by special rules in France.
– The CNIL has provided a FAQ in English (with link to the standard) :
https://www.cnil.fr/en/faq-health-vigilance-systems-standard
Standard at
https://www.cnil.fr/sites/default/files/atoms/files/standard_personal-data_health-vigilance-systems.pdf