Forms - Pharmacovigilance
Here you will find forms listed on the topic Pharmacovigilance.
| Title | Date | Download |
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Reporting form for adverse drug reactions (ADR) If you have observed an adverse drug reaction that you wish to report, please use the form provided here in the table. ADR s can also be reported online. Since the scientific assessment of reported events requires specialised medical information, the BfArM usually accepts ADR reports from health care professionals only. Therefore, if you are not a health care professional you are advised to ask your physician to fill in the reporting form for you. |
2010.02.23 |  download (file size: 363 KB) |
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Reporting form for communication of quality defects, batch recalls, and counterfeit drugs Click here for the reporting form with which pharmaceutical companies can communicate quality defects, batch recalls and counterfeit drugs to the competent authority. |
2010.09.28 |  download (file size: 38 KB) |
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Form for submission of PSURs Form for submission of PSURs |
2010.08.24 | download (file size: 264 KB) |
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Form for prolongation of the PSUR submission interval |
2010.08.24 | download (file size: 206 KB) |