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Guidelines for Preparation of New Drug Submissions for Products Used for Estrogen-Progestin Replacement Therapy in Menopause (HRT) (PDF Version - 34 K) Contact: BMORS Enquiries Therapeutic Products Programme Tunney's Pasture Address Locator # 0702A Ottawa, Ontario K1A 0L2 April…

Guidance for Industry - Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products (PDF Version - 107 K) Contact: BMORS Enquiries April 20, 2006 Notice Our file number: 06-105995-589 The final version of this Health Canada guidance document Product Monographs…

Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products (PDF Version - 208 K) Notice April 18, 2012 Our file number: 12-104742-88 Release of Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products Health Canada is pleased to announce…

Helicobacter pylori Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI diseases [1999-04-01] Page details 2017-05-04

Haemodialysis Solutions (PDF Version - 23 K) Contact: BPS Enquiries Class Monograph Haemodialysis Solutions Description: This monograph applies to products in the form of liquid concentrate that are intended to be used for acute and chronic haemodialysis. The medicinal…

Good manufacturing practices guide for drug products (GUI-0001) - Summary Guidance on Drug Establishment Licences (GUI-0002) Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) Risk classification guide for drug good…

Good Guidance Practices Good Guidance Practices ( GGP s) are the definitions, procedures and practices for the development, issuance and use of the various documents that provide guidance to staff and stakeholders of the Therapeutic Products Directorate ( TPD ) and the Biologics…

The Use of Foreign Reviews Draft Guidance Document - The Use of Foreign Reviews by Health Canada [2012-09-28] Foreign Review Attestation Form (for human and veterinary biologics, disinfectants, radiopharmaceuticals and pharmaceuticals, and medical devices products) [2012-09-28]…

Notifying Health Canada of Foreign Actions - Guidance Document for Industry Three-part list of foreign regulatory authorities Electronic on-line form Adverse Reaction and Medical Device Problem Reporting Food and Drugs Act Food and Drug Regulations Drugs and Health Products…

Drugs Currently Regulated as New Drugs Listing of drugs currently regulated as new drugs [2012-11-06] Page details 2017-05-04