Nonclinical Studies GLP Compliance1 (annex To The Cover Letter)

non-clinical studies glp compliance1 (annex to the cover letter) study title/code date of completion of the final report test facil

Non-clinical studies GLP compliance1 (annex to the cover letter)
Study title/code
Date of completion of the Final Report
Test Facility/test site in which the study was conducted (name and
complete address)*
Period in which the test facility/test site was used.
Was the Test Facility/test site in that period part of an EU or an
OECD Mutual Acceptance of Data (MAD) accepted GLP monitoring
programme? (Y/N)
1 Please see question 37 of the “Pre-submission Guidance” for further
information.
* include a row for each test facility/test site