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Guidance Document: Tamper-resistance Formulations of Opioid Drug Products (PDF Version - 109 K) Date adopted: 2016/03/10 Effective Date: 2016/03/30 Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with…
Opioid Warning Sticker and Patient Information Handout, and Risk Management Plans On this page: List of Class A Opioids Information for Patients Concerning Opioids Part A: Opioid Warning Sticker Part B: Opioid Patient Information Handout Risk Management Plans Notices Health…
Official Method: Thyroid (PDF Version - 17 K) Contact: BMORS Enquiries Published by authority of the Minister of Health Date: 1981/10/15 Administrative Changes Date: 2003/11/17 Health Products and Food Branch I. Application This method shall be used to assay Thyroid as referred…
Official Method: Determination of Net Contents (PDF Version - 16 K) Contact: BPS Enquiries Published by authority of the Minister of Health Date: 1988/12/07 Administrative Changes Date: 2003/11/17 Health Products and Food Branch Application This method shall be used to determine…
Official Method: Determination of the Disintegration Time of Tablets (PDF Version - 111 K) Contact: BPS Enquiries Published by authority of the Minister of Health Date: 1989/07/05 Administrative Changes Date: 2003/11/17 Health Products and Food Branch I. Application This method…
Official Method: Conjugated Estrogens (PDF Version - 15 K) Contact: BMORS Enquiries Published by authority of the Minister of Health Date: 1981/10/15 Administrative Changes Date: 2003/11/17 Health Products and Food Branch I. Application This method shall be used for the…
Guidance Document: Notice of Compliance with Conditions (NOC/c) (PDF Version - 448 Kb) Please note: On June 13, 2015, the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) , commonly known as the Plain Language…
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Basic Product Monograph Information for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) [2006-11-23] Page details 2017-05-04
Non-prescription Drugs: Category IV Monographs A non-prescription drug (NPD) Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof.…
Questions and Answers - Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice (PDF Version - 108 K) Applicability Issues Recognition Issues Acceptance of Study Data Standards Council of…
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