Sentence examples for authorization holder from inspiring English sources

Typically, risk-minimization programs are designed by staff from the central office of the marketing authorization holder (MAH) in conjunction with the requesting health authority.

This exemption is applicable for the Netherlands, because FDOPA is a licensed radiopharmaceutical, but not available for use, since the current manufacturing authorization holder does not produce FDOPA.

Moreover European Public Assessment Report (EPAR) and data supplied by marketing authorization holder (GlaxoSmithKline) were reported.

Additionally, the prospective market authorization holder also must demonstrate lack or at least comparable immunogenicity in long-term clinical trials.

For every data entry or data update in the national database, the relevant Market Authorization Holder is notified to avoid duplicate sending to Eudravigilance.

T.C is an employee of Sanofi Pasteur MSD which is the marketing authorization holder of the herpes zoster vaccine (Zostavax) in Europe.

All serious ADRs reported worldwide for all drugs approved within the EU are mandated to be reported to the EV from all marketing authorization holders and EU drug authorities.

PSURs facilitate communication between regulators and marketing authorization holders.

Marketing authorization holders (MAHs) have the obligation to monitor the safety of their products after their product receives marketing authorization.

Japanese marketing authorization holders (MAHs) complied with the obligation to report adverse events within the legally determined duration.

This would also enable further research on how complexity drives market authorization holders' behavior when it comes to SA.