For Healthcare Professionals
The reporting of suspected adverse reactions after the authorization of a medicinal product is important in order to ensure continued monitoring of the product’s benefit/risk balance. According to the requirements of the Medicinal Products in Human Medicine Act (MPHMA), healthcare professionals are obliged to immediately report to the marketing authorization holder or to the Bulgarian Drug Agency (BDA) any suspected serious adverse drug reaction and, upon request, to provide additional follow-up information regarding the case.