GLP compliance - European Medicines Agency
Revision 1.1
Non-clinical studies GLP compliance[1] (annex to the cover letter)
|Study title/code |Date of completion of |Test facility/test site in which the study was |Period in which the test |Was the test facility/test sitein |
| |the Final Report |conducted (name and complete address)* |facility/test site was used |that period part of an EU or an |
| | | | |OECD Mutual Acceptance of Data |
| | | | |(MAD) accepted GLP monitoring |
| | | | |programme? (Y/N) |
| | | | | |
| | | | | |
| | | | | |
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[1] Please see question 3.4.1 of the “Pre-authorisation guidance” for further information.
* Include a row for each test facility/test site.
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