Description

This Guidance document provides information on the interpretation and application of sections C.03.301 to C.03.320 of the Food and Drug Regulations (the Regulations) applicable to positron-emitting radiopharmaceuticals (PERs) used in basic clinical research studies.

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Name	Format	Description	Link
Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/guidance-document-guide-preparation-applications-authorization-radiopharmaceuticals.html#a1
Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/guidance-document-guide-preparation-applications-authorization-radiopharmaceuticals.html#a1

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