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Parcourez et recherchez des captures historiques. Ceci est une archive — pas des directives actuelles ni un avis médical. Le contenu archivé peut être incomplet, périmé ou remplacé. Pour des recommandations à jour, consultez toujours le site officiel de la source.

Pour plus de contexte sur la couverture et les méthodes de capture, voir Méthodes et couverture.

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New agile regulatory provisions and updated guidance document for submitting risk management plans: Notice On this page New provisions for risk management plans Consultations Transitioning to the new regulations Guidance on submitting risk management plans Contact us New…

Guidance document: Labelling of pharmaceutical drugs for human use Download in PDF format (976 KB, 65 pages) Organization: Health Canada Date adopted: 2013-11-01 Date revised: 2024-12-18 Effective date: 2024-12-18 Foreword Guidance documents are meant to provide assistance to…

Quality (chemistry and manufacturing) guidance: New Drug Submissions and Abbreviated New Drug Submissions Download in PDF format (782 KB, 75 pages) Organization: Health Canada Date adopted: 2017/10/30 Revised date: 2024/12/18 Effective date: 2024/12/18 Foreword Guidance documents…

Guidance on the Food and Drug Regulations for public health emergency drugs: Overview Overview Preparing a drug submission for a PHED Drug establishment licences, good manufacturing practices Post-market requirements Pre-positioning a public health emergency drug References, key…

Notice: Multiple additions to the Prescription Drug List (PDL) [2024-12-20] December 20, 2024 Our file number: 24-111533-667 The purpose of this Notice of Amendment is to notify about the addition of avapritinib, exagamglogene autotemcel (human), ilunocitinib (veterinary),…

New terms and conditions for human and veterinary drugs: Notice December 20, 2024 On this page New agile amendments introduced Consultation on proposed amendments When the new T&C authority comes into force New draft guidance documents Contact us New agile amendments introduced…

Notice to stakeholders – Publication of the final product monograph guidance document and master template (2024) December 23, 2024 Reference number: 24-110062-750 This Notice is to inform stakeholders of the publication of the finalized 2024 versions of the Guidance document:…

Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada From: Health Canada Current status: Closed Opened from December 28, 2024 to March 8, 2025. Health Canada has proposed to amend the Food and Drug Regulations and…

Validation rules for regulatory transactions in non-eCTD format January 10, 2025 Our file number: 24-111718-360 Health Canada has updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information…

Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format January 10, 2025 Our file number: 24-111717-221 Health Canada has updated the validation rules for regulatory transactions submitted in the electronic Common Technical Document…

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