URSAPHARM Arzneimittel GmbH

Main PRRC for: Art. 15 (EU) 2017/745 Contact to EUDAMED, Health Authorities and Notfied Bodies

Deputy PRRC for: Art. 15 (EU) 2017/745 Contact to EUDAMED, Health Authorities and Notfied Bodies Main PRRC for: Article 15, (3) a), Annex I - IV Check of conformity of manufactured products with QMS and release (internal processes – liquid dosage forms)

Main PRRC for: Article15, (3) a), Annex I - IV Check of conformity of manufactured products with QMS and release (internal processes – semi-solid dosage forms) Deputy PRRC for: Article 15, (3) a), Annex I - IV Check of conformity of manufactured products with QMS and release (external processes – quality of externally manufactured products)

Main PRRC for: Article 15, (3)a) and (3)e, Annex I - IV and Annex XV, Chap. II, 4.1 Check of conformity of manufactured products with QMS and release (internal processes - test medication for clinical trials and external processes – quality of externally manufactured products) Deputy PPRC for: Article 15, (3) a), Annex I - IV Check of conformity of manufactured products with QMS and release (internal processes – semi-solid dosage forms and liquid dosage forms)

Main PRRC for: Article 15, (3)c), Art. 80, Art. 83 ff. Post Market Surveillance Main PRRC for: Article 15, (3)d), Art. 80, Art. 87 – 91 Vigilance Reporting

Deputy PRRC for: Article 15, (3)c), Art. 80, Art. 83 ff. Post Market Surveillance Deputy PRRC for: Article 15, (3)d), Art. 80, Art. 87 – 91 Vigilance Reporting