Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)

Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food and Drug Regulations. Section C.05.010(j) requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials shall ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.

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Title (French)	Document d'orientation : Annexe 13 à l'édition actuelle des Lignes directrices sur les Bonnes pratiques de fabrication Médicaments utilisés dans les essais cliniques (GUI-0036) [Santé Canada, 2009]
Update Frequency	as_needed
Geographic Scope	[]
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Sensitivity Level	unrestricted
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Open Canada Date Published	2020-11-16 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["bonnes pratiques de fabrication", "document d'orientation", "médicaments utilisés dans les essais cliniques", "GUI-0036"], "en": ["good manufacturing practices", "guidance document", "drugs-used in clinical-trials", "GUI-0036"]}
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