Submission of PSURs
Submission of Periodic Safety Update Reports (PSURs) by marketing authorisation holders (MAH) is required pursuant to section 63 b (documenting and reporting obligations) of the German Medicines Act (AMG).
In the following we provide responses to frequently asked questions (FAQs) about PSUR submissions. In particular we would like to refer to the 
Form for submission of PSURs (file size: 264 KB) with the attached medicinal products list which lists all the formal specifications that must be provided in a PSUR. From now on, please use the amended rtf-form only for PSUR submission (state: 24 August 2010)
For questions not answered here we refer to Part I, Chapter 6 of "Volume 9A of the Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use" (state: September 2008).
For further inquiries please contact the PSUR-Management-Team of the BfArM Pharmacovigilance Unit (please do not send any PSUR data files to this address):
e-mail: PSUR@bfarm.de
phone: 0228-207-5777 or 0228-99307-5777
August 24, 2010
|
Question |
Answer |
|---|---|
| Where shall PSURs be sent to? | To:Federal Institute for Drugs and Medical Devices (BfArM) - Pharmacovigilance – PSUR … |
| Which formal specifications are required for PSURs? | Because of the many requests received, BfArM has set up a containing all the specifications … |
| Should PSURs be submitted electronically and/or as hard copies? | All PSURs are required to be submitted on a CD/DVD (for format see next FAQ). If created in eCTD- or … more: Should PSURs be submitted electronically and/or as hard copies? … |
| What should be considered of CD-ROMs/DVDs? | BfArM accepts pre-checked CDs /DVD s in eCTD format (preferred) or NeeS. Please follow the advice … |
| Do you send acknowledgements of receipt? | When the administrative processing is completed the applicant is e-mailed an acknowledgement of … |
| What are the rules for compiling PSURs? | Compilation of PSURs should follow the rules given in Volume 9A. |
| Which documents should be attached to PSURs? | Attach the CCSI, the Fachinformation (German SPC) / Gebrauchsinformation (German Package Leaflet), … |
| Which medicinal products may be presented combined in one PSUR? | A combined PSUR is principally possible for products containing the same substance or substance … more: Which medicinal products may be presented combined in one PSUR? … |
| What should be considered for submission of several PSURs for one medicinal product/substance in one reporting period? | The legal submission intervals should be followed. Submission of one PSUR in a reporting period is … |
| May reporting intervals be shortened? | Yes, this is possible without special application. It should be noted, though, that PSURs should not … |
| May reporting intervals be prolonged? | Yes, this is possible for known substances provided BfArM has accepted an application for … |
| May several MAHs/pharmaceutical companies submit a joint PSUR? | No. The AMG as well as Volume 9A provide that each MAH submits his own PSUR. The submission of a … more: May several MAHs/pharmaceutical companies submit a joint PSUR? … |
| May authorised persons submit PSURs? | Yes. However, the MAH remains the addressee for the Kostenbescheid (notice of fees and expenses) and … |
| Which products do not require PSURs? | The following products are exempt from the PSUR requirement: parallel imports standard … |
| How are the processing fees determined? | When the scientific assessment of a PSUR is completed a notice of fees and expenses (Kostenbescheid) … |
| Will an assessment report be written in every case? | Assessment reports for centrally authorised products (CAPs) are sent by EMA, for MRPs/DCPs by the … |
| What should be considered for participation in the PSUR Worksharing Project (WSP)? | The website of the Heads of Medicines Agencies provides detailed information on submission of PSURs … more: What should be considered for participation in the PSUR Worksharing Project (WSP)? … |