VO-Form

Report of an Adverse Drug Reaction to a TpP/GT/GMO

Accompanying form for reporting a suspected adverse drug reaction to an authorised transplant product (TpP) / gene therapy product (GT) or an authorised product consisting of, or containing, genetically modified organisms (GMO).

Sender:Received by Swissmedic (please leave blank)

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Date of submission: / ……
Name of TpP/GT/GMO: / ……
Authorisation number (if known):
Country (location of event):…… / ……
Swissmedic ref. number (if known, otherwise to be completed by Swissmedic): / ……
Case number for sender / authorisation holder / sponsor / patient number (optional): / ……
Date of receipt by the authorisation holder / reporting individual: / ……
Responsible person / contact / e-mail: / ……
Product category:
☐Somatic cell therapy / ☐Tissue engineering / ☐Gene therapy / ☐GMO / ☐Other ……
Active substance: / ……
Report type: / ☐Spontaneous
☐Approved trial / ☐Literature
☐Other
Reported by: / ☐Sponsor
☐Manufacturer / ☐Hospital/doctor
☐Other / ☐Patient
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☐Switzerland / ☐Abroad
Country: ……

If you are not submitting an accompanying CIOMS form, please complete the following patient details:

Age of patient: / ……
Sex: / ☐Female☐Male
Relevant medical history: / ……
Co-medication incl. start/end dates: / ……
Start date of the SAE: / ……
Description of the event: / ……
Presumed link with the following product/s: / ……
Dosage: / ……
Administration route: / ……
Indication / ……
Start of treatment: / ……
Date of last administration before the event: / ……
End of treatment: / ……
Improvement after discontinuation of the product: / ☐Yes☐No☐not applicable
Deterioration after resumption of treatment / ☐Yes☐No☐not applicable
Healed: / ☐Yes☐No
☐Serious adverse drug reaction / ☐Fatality / date ……
☐Life-threatening
☐Hitherto unknown adverse drug reactions
☐Clusters of known or hitherto unknown adverse drug reactions
☐Manufacturing problem / ☐Quality defect
☐Harvesting/donor problem / ☐Administration problem
☐Release into the environment (GMO only)
☐Transmission to another person (GMO only)
☐To an animal / animal species …… (GMO only)
If trial report (SUSAR/SADR)*
Swissmedic reference number / EC number of the trial: / ……
If report is not from Switzerland, trial number
and country: / ……
Report concerns: / ☐Initial report
☐Follow-up / no.: ……
☐Associated initial report: ……
Relevant additional info expected within the next 14 days: / ☐Yes☐No
Administration of TpP/GT/GMO during pregnancy: / ☐Yes☐No

ADR terms (adverse drug reaction term):

/ Labelled in CH IHP / SmPC / IB *
yes / no
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* IB / IHP: Investigator’s brochure / Information for healthcare professionals, text most recently approved by Swissmedic

Brief text excerpt on related adverse reactions from the IHP* if the events are not described verbatim in the IHP:
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Approved trial: If SUSAR/SADR: quote what is already documented in the corresponding organ class in the IB* and comment on the relatedness between the medication and the event:
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Are/were risk-minimising measures (being) initiated: / ☐Yes☐No
Comments:
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Further comments on the case:
Case discussion – what does the company know about the problem – missing details – statement on labelling
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Please send to:
(preferably)
or (in exceptional cases) to:
Swissmedic
Swiss Agency for Therapeutic Products
Division Inspectorates and Licences
Case Manager, Section Transplants
P.O.Box
3000 Berne 9 /
Enquiries:
Telephone:+41 58 462 02 11
Fax:+41 58 462 04 19

QMI Ident: I-314.AA.01-A03e / V02 / fco / jd / smi / 24.03.20171 / 3

Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • • Phone +41 58 462 02 11 • Fax +41 58 462 02 12