Periodic security up-date records is pharmacovigilance documents designed to give an excellent safety revise leading to a review of your own impact of records towards chance-work for harmony regarding a healing product. They shall be registered BesГёk hjemmesiden from the product sales authorisation proprietors on discussed time facts inside the article-authorisation stage.

Further facts and you may suggestions toward distribution from PSURs from the European union, like the range of Commitment records times and you can regularity away from distribution are provided in Module VII “Unexpected defense revise statement” of the tip into the a beneficial pharmacovigilance practices (GVP) along with next questions and answers. Lire la suite