submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure. During a PSUSA procedure PSURs of medicines containing the same active substances or combinations, [...] different types of referrals can be found on the website of the European Medicines Agency (EMA). PSUSA (PSUR single assessment) - Article 107e of Directive 2001/83/EC PSURs are pharmacovigilance documents [...] the European Economic Area. If at least one centrally authorised medicinal product is included in a PSUSA procedure, the European Commission adopts a Commission Decision. Further information on Periodic safety

product, for which no PSUR is requested, receive the assessment report of a PSUSA procedure? No, but the outcome of the PSUSA will be published on the EMA homepage or on the BASG homepage: https://www.basg [...] substances which are according to the EURD list required to submit a PSUR. These PSURs are part of the PSUSA process (PSUR Single assessment). For all pure NAP procedures, not listed on the EURD list A submission [...] storage place for PSURs, PSUR Assessment Reports (ARs), comments and final outcomes. Both PSURs for PSUSA-procedures ("EU-single assessments") and PSURs for national PSUR submissions ("non-EU single assessments")

should also be noted that any deviations from an EU harmonised wording (following a recently finalised PSUSA procedure) must be duly justified by means of a Type II Variation. IMPORTANT EVENT BASG dialogue:

PHV-wordings Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV issues. Due to the relaunch of the EMA website in December 20