Pharmakovigilanz, PV-Systeme und PSURs von Diapharm Dr. Ebeling & Assoc GmbH B.A.H WIDI Dr. Ebeling & Assoc GmbH Pharmakovigilanz, PV-Systeme und PSURs von Diapharm
 
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Time Schedule and Data Lock Points for Various Substances

 

Recherche Ia
for classification
 
Recherche Ib
after
PSUR order
DATA LOCK

Recherche II
literature order
Delivery of
PSUR

to the companies
Submission date

to the BfArM
 
 
time/days
- 120
- 90
- 60
- 20
0
  
BAH call
Company feedback
Company-specific data
CIOMS forms
SPC, package leaflet and changes to the authorisation profile
       

         

Here are the data lock points for more than 2000 substances, classified according to year:

Data Lock Points for Chemically Defined Substances*

download as .xls-file
download as .pdf-file

Data Lock Points for Substances of Special Therapies*

year 2010
year 2011
year 2012

all substances sorted alphabetically

* Syntax of DLP: YYYYMM, e.g. 200812 means December 2008.
   The PSURs should be submitted within 60 days to the regulatory authority
 
 
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