https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-rev-2_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-rev-2_en.pdf
