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Interventional Studies
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Definition
How to conduct a Clinical Trial in Portugal?
How to conduct
How to participate in a Clinical Trial in Portugal and in the European Union?
Legislation
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Information to Sponsors
How to submit a Clinical Trial application in Portugal?
How to submit a Substantial Amendment Notification?
How to submit a End of Trial Notification and a Clinical Trial Report Notification?
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Medical Devices
Definition
How to conduct a clinical Investigation of devices in Portugal?
How to participate in a clinical investigation of devices in Portugal?
Legislation
Portugal
European Union
Information to the Sponsor
How to submit an application for a clinical investigation of medical devices in Portugal?
How to submit a Substancial Amendment?
Report of Serious Adverse Events and device deficiencies
How to submit the Notification of the Termination and Final Report?
FAQs
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Cosmetics
Definition
How to conduct a Clinical Study in Portugal?
How to conduct
How to participate in a Clinical Study in Portugal?
Legislation
Portugal
European Union
Information to the Sponsor
How to submit an application for a Clinical Study in Portugal?
How to submit a Substancial Amendment?
How to submit the Notification of the Termination and Final Report?
Other Notifications
Report of Serious Adverse Events
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Non Interventional Studies
Medicinal Products
Post-authorisation Safety Studies (PASS)
Definition
Legislation
Submission instructions to INFARMED I.P.
Submission instructions to CEIC
ADR Report
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Post-authorisation efficacy studies (PAES)
Definition
Legislation
Submission instructions to INFARMED I.P.
Submission instructions to CEIC
ADR Report
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