Legal framework – pharmacovigilance

On 2 April 2013 an amendment to the Medicinal Products Act came into force and on 1 September 2013 an amendment to the Registration Ordinance came into force. A new paragraph §17a was inserted into the amendment to the Registration Ordinance, which governs all safety studies (conducted pursuant to §93j of the Medicinal Products Act). We present the most important changes in the field of pharmacovigilance, registration and clinical trials in the form of questions and answers.