Authorized Representatives

Any pharmaceutical entrepreneur in Germany has to appoint a number of authorized representatives.

For example, a pharmaceutical entrepreneur who places finished medicinal products on the market in Germany must appoint a qualified person resident in a member state of the European Union, who has the required expertise and reliability necessary for exercising his/her function (Graduated Plan Officer) in accordance with Section 63a of the German Medicines Act. It is the responsibility of the Graduated Plan Officer to set up and to manage a pharmacovigilance system and to collect and to evaluate notifications on medicinal product risks that have become known and to coordinate the necessary measures. The Graduated Plan Officer must be notified to the competent authority and the competent higher federal authority.

Phavigus is able to offer the following authorized representatives:

• Graduated Plan Officer according to Section 63a of the German Medicines Act

• Qualified Person responsible for Pharmacovigilance (QPPV) according to Article 104 (3) (a) of Directive 2001/83/EC

• Quality Management Representative (QMR)