RSS
Sitemap
Login (HMA-DMS)
Contact
Search
About HMA
Human Medicines
Veterinary Medicines
You are here:
Home
>
Human Medicines
>
CMDh
>
Pharmacovigilance
>
PSUR
>
Informal PSUR Worksharing
CMDh
About CMDh
Statistics
Agendas and Minutes
Press Releases
COVID-19
BREXIT
Nitrosamine impurities
Procedural Guidance
CMDh-Referrals
Product Information
Advice from CMDh
Templates
CMD Working Parties / Working Groups
Paediatric Regulation
Pharmacovigilance
General Information
Referrals
PSUR
PSUR Single Assessment
Informal PSUR Worksharing
Outcome of informal PSUR worksharing procedures
PSUSA Follow-up
Outcome of PSUR Follow-up procedures
PSUR Work Sharing and Synchronisation Project
RMP
Article 57
Falsified Medicines
Questions & Answers
Contact Points
Recently Published history
MRI Product Index
Pharmacovigilance
Availability of Medicines
Publications and reports
National Contacts
Informal
PSUR
Worksharing
Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding/followed
(January 2025) [
Track version
]
Template - PSUR Assessment Report
