What's new: Natural and non-prescription health products
The latest additions and significant updates to the Natural and Non-Prescription Health Products section.
COVID-19
- Lifting the interim policy for cleaning products for use, handling or storage in workplaces (COVID-19): Notice [2022-04-12]
- Lifting the interim policy for household cleaning products, hand soaps and body soaps (COVID-19): Notice [2022-04-12]
- Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations [2022-03-02]
- Notice of updated guidance: Applications for COVID-19 drug clinical trials under the Regulations [2022-03-02]
- Notice: Period reduced for keeping clinical trial records for drugs and natural health products [2022-03-02]
- What we heard report: Records retention consultations related to the clinical trials interim order transition regulations [2021-11-19]
- Production of isopropyl alcohol for use in alcohol-based hand sanitizers: interim guide
- Applying for a Drug Identification Number (DIN) for a disinfectant drug during the COVID-19 pandemic
- Alcohol-based hand sanitizers in beverage and food containers: Packaging and labelling requirements to reduce unintentional ingestion risk
- Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer
- Manufacturers of hand sanitizers using technical-grade ethanol
- Labelling of hand sanitizers, disinfectants, soaps and cleaning products in the context of the COVID-19 response
- Technical-grade ethanol for the manufacture of hand sanitizers during the COVID-19 pandemic: Risk assessment summary report
- Suppliers of technical grade ethanol for use in the production of hand sanitizers
- Health Product Advertising Incidents related to COVID-19
- Health Canada's decision to temporarily allow technical grade ethanol for the manufacture of hand sanitizers - Notice to industry
- COVID-19 health product industry
- Hard surface disinfectants and hand sanitizers (COVID-19)
- Interim guide on the production of ethanol for use in alcohol-based hand sanitizers
- Guide on Health Canada's Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers
2022
December
- Non-prescription Drug Action Plan [2022-12-08]
November
- Consultation: Release of Draft (Step 2) ICH M11 guideline, technical specification and template [2022-11-18]
- Changes to list of certain non-prescription drugs for distribution as samples (List D): Notice of modification [2022-11-16]
- Consultation: Release of Draft (Step 2) ICH guideline, ICH Q5A(R2) [2022-11-02]
October
September
- Consultation Extension: Draft (Step 2) ICH Guideline E11A [2022-09-29]
- Updated: Guidance on nitrosamine impurities in medications [2022-09-01]
August
- Notice: Implementation of (Step 4) ICH Q3D(R2) Guideline - Revision of Q3D(R1) for cutaneous and transdermal products [2022-08-29]
- Health Canada recommendations for implementation of the Revised ICH Harmonised Guideline for Elemental Impurities Q3D(R2) for cutaneous and transdermal products [2022-08-29]
- Notice: Revisions to the performance standards for Post-authorization Division 1 Changes [2022-08-02]
- Updated: Guidance Document Post-Drug Identification Number (DIN) Changes [2022-08-02]
July
- Consultation: Release of Draft (Step 2) ICH guideline, ICH M12 [2022-07-29]
- Consultation: Exceptions to the Prescription Drug List [2022-07-29]
- PDD/BRDD/NNHPD Drug Submission Performance Annual Report – Fiscal Year 2021-2022 [2022-07-25]
- Surface disinfectants for emerging viral pathogens [2022-07-25]
- Amendments to the Natural Health Products Regulations [2022-07-06]
- Labelling of Natural Health Products guidance document [2022-07-06]
- Evidence for Homeopathic Medicines guidance document [2022-07-06]
June
- PDD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q4-2021-2022 [2022-06-30]
- Draft ICH guideline Q2(R2): Revision to Analytical Validation [2021-06-13]
- Draft ICH guideline Q14: Analytical Procedure Development [2021-06-13]
- Draft ICH guideline E11A: Paediatric Extrapolation [2021-06-13]
- Notice: Release of Final (Step 4) ICH Q&A Document, ICH E14/S7B: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential [2022-06-10]
May
- Consultation on proposed Biocides Regulations [2022-05-07]
April
March
- Classification of products for moxibustion: Notice to stakeholders [2022-03-14]
- TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q3-2021-2022 [2022-03-11]
- Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
February
January
2021
December
September
July
- TPD/BRDD/NNHPD Annual Drug Submission Performance report - Fiscal Year 2020-2021 [2021-07-20]
- TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q4-2020-2021 [2021-07-13]
June
April
- Health Canada responds to the Spring 2021 Report of the Commissioner of the Environment and Sustainable Development
- Report of the Commissioner of the Environment and Sustainable Development - Natural Health Products
March
January
- Regulatory innovation for health products [2021-01-29]
2020
December
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
November
July
June
- Natural Health Product Licence Application Form version 4.0 [2020-06-15]
April
2019
March
December
September
June
March
February
2018
November
- NNHPD Quarterly Drug Submission Performance report for July - September 2018 [2018-11-26]
- Web-based Natural Health Product Licence Application Form (web PLA form) [2018-11-26]
August
July
June
March
January
- Notice - Updates to the Prescription Drug List [2018-01-04]
- Updates to the Prescription Drug List [2018-01-04]
2017
November
October
- Notice - Prescription Drug List (PDL): Multiple Additions [2017-10-19]
- Updates to the Prescription Drug List [2017-10-19]
September
- Natural and Non-prescription Health Products Directorate Upcoming activities: Aug to Dec 2017 [2017-09-01]
August
June
- Updates to the Prescription Drug List [2017-06-23]
May
- Natural and Non-prescription Health Products Directorate (NNHPD) Upcoming activities: May 1, 2017 to September 30, 2017 [2017-07-14]
- Updates to the Prescription Drug List [2017-05-19]
April
- Updates to the Prescription Drug List [2017-04-21]
March
- Updates to the Prescription Drug List [2017-03-29]
February
- Updates to the Prescription Drug List [2017-02-10]
2016
December
November
- Updates to the Prescription Drug List [2016-11-16]
September
- Guidance Document: Acetaminophen Labelling Standard [2016-09-15]
- Consultation - Regulation of self-care products [2016-09-08]
August
- Prescription Drug List [2016-08-26]
- Prescription Drug List [2016-08-18]
- Natural and Non-prescription Health Products Directorate (NNHPD) six-month calendar of activities: July to December 2016 [2016-08-17]
- Prescription Drug List [2016-08-09]
May
- Update - Natural Health Products Online Solution: Frequently Asked Questions [2016-05-16]
- Update - Notice to Stakeholders Regarding the Results of the Class Redistribution Pilot [2016-05-16]
April
- Updated - Prescription Drug List [2016-04-22]
- The Non-Prescription and Natural Health Products Directorate is moving - new physical and mailing addresses [2016-04-14]
- Summary Report on the Consultation on a Framework for Consumer Health Products: What We Heard [2016-04-01]
March
- Updated - Prescription Drug List [2016-03-22]
February
- Natural and Non-prescription Health Products Directorate (NNHPD)'s Calendar of Activities (January to June 2016) [2016-02-10]
- Consultation - New Monographs (First Aid Antiseptics) [2016-02-09]
- Consultation - Revised Monograph (Selenium) [2016-02-09]
- Final Mongraph for Antiseptic Skin Cleanser [2016-02-09]
- Consultation - Revised Monograph (Multi-Vitamin/Mineral Supplements) [2016-02-09]
January
- Labelling Standard for Non-prescription Oral Adult Nasal Decongestant [2016-01-26]
- Communication on changes to the Non-prescription Drug Monograph Attestation Process [2016-01-15]
- Revised Monograph (White Kidney Bean Extract) [2016-01-12]
- Consultation - Revised Monograph (Acne Therapy) [2016-01-26]
- Prescription Drug List [2016-01-08]
2015
December
- Consultation - New Monograph (Medicated Vapours) [2015-12-08]
- Final Monograph for Hydrocortisone [2015-12-08]
- Final Monograph for Maitake [2015-12-08]
- Final Monograph for Poria [2015-12-08]
- Final Monograph for Mushrooms [2015-12-08]
- Final Monograph for Pygeum [2015-12-08]
- Final Monograph for Aromatherapy [2015-12-08]
- Final Monograph for Indole-3-carbinol [2015-12-08]
- Final Monograph for 3,3'-Diindolylmethane (DIM) [2015-12-08]
- Final Monograph for Soy Flour [2015-12-08]
- Final Monograph for Betaine/Betaine Hydrochloride [2015-12-08]
- Final Monograph for Bearberry [2015-12-08]
- Final Monograph for Olive Leaf [2015-12-08]
- Good Manufacturing Practices Guidance Document [2015-12-01]
- Site Licensing Guidance Document [2015-12-01]
- Notice to Stakeholders Regarding Site Licensing Update [2015-12-01]
October
August
- Prescription Drug List [2015-08-12]
July
- Information on Homeopathic Products [2015-07-31]
- Revised Guidance Document (Homeopathic Medicines) [2015-07-31]
- Finalized Revised Labelling Standard (Topical Anaesthetic, Analgesic, Antipruritic) [2015-07-29]
- Finalized New Labelling Standard (Oral Adult Antitussive) [2015-07-28]
- Finalized New Labelling Standard (Oral Stool Softener Laxatives) [2015-07-28]
- NNHPD's Calendar of Activities (July to December 2015) [2015-07-16]
- Revised Monograph (American ginseng) [2015-07-08]
June
- Prescription Drug List [2015-06-26]
- Revised Monograph (Hard Surface Disinfectants)
- Revised Monograph (Traditional Chinese Medicine Ingredients)
- Revised Monograph (Homeopathy)
- Consultation - New Labelling Standard (Oral Adult Decongestant) [2015-06-01]
May
- Prescription Drug List [2015-05-29]
- Quality of Natural Health Products Guide [2015-05-12]
April
- Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard [2015-04-01]
- Revised Labelling Standard (Oral Stool Softener Laxatives) [2015-04-01]
March
- Prescription Drug List [2015-03-26]
February
January
2014
December
- Consultation - Revised Monograph (Hydrocortisone - Topical) [2014-12-29]
- Prescription Drug List [2014-12-24]
- Consultation - Revised Labelling Standard (Topical Anaesthetic, Analgesic, Antipruritic) [2014-12-19]
- Prescription Drug List [2014-12-05]
November
- Consultation - Consumer Health Products Framework [2014-11-27]
- Consultation - Development of new monograph (Chlorella) [2014-11-18]
- Consultation - Development of new monographs (Betaine/Betaine Hydrochloride and Olive Leaf - Olea Europaea) [2014-11-04]
- Management of product licence applications for natural health products [2014-11-03]
October
- Consultation -Development of new monographs (Bearberry - Arctostaphylos uva-ursi and Aromatherapy - Essential Oils) [2014-10-07]
September
- Natural and Non-prescription Health Products (NNHPD) six-month calendar of activities: July to December 2014 [2014-09-25]
- Prescription Drug List [2014-09-16]
August
- Consultation - Development of new and revised monographs (Aloe Vera Leaf Gel - oral, African Wild Mango, Kutki and Antiseptic Skin Cleansers) [2014-08-26]
- Prescription Drug List [2014-08-22]
- Natural and Non-prescription Health Products Directorate - Quarterly snapshot - Quarter 1 (Fiscal year 2014-2015) [2014-08-05]
July
- Non-prescription drug monograph attestation pilot [2014-07-10]
- Prescription Drug List [2014-07-02]
June
- Management of product licence applications for natural health products [2014-06-30]
- Consultation - Development of new monograph (Cognitive Function Products and Royal Jelly) [2014-06-17]
- Consultation - Site licensing guidance document [2014-06-13]
- Consultation - Quality Assurance Report form [2014-06-13]
- Consultation - Good Manufacturing Practices Guidance Document [2014-06-13]
May
- Expectorant - Adult [2014-05-30]
- Topical Nasal Decongestants [2014-05-30]
- Consultation - Development of new monograph (Red Clover Isoflavone Extract) [2014-05-21]
- Prescription Drug List [2014-05-12]
- Data requirements for switching medicinal ingredients from prescription to non-prescription status [2014-05-07]
April
- Consultation - Development of new Monograph (Black Walnut) [2014-04-23]
- Consultation - Development of new and revised monographs (Spirulina, Oral Health Products and Reishi) [2014-04-08]
March
February
- Prescription Drug List [2014-02-18]
- Consultation - Message to natural health product stakeholders regarding the development of a monograph: Traditional Chinese Medicine Ingredients [2014-02-11]
January
- Common Electronic Submissions Gateway [2014-01-31]
- Consultation - Message to natural health product stakeholders regarding development of pre-cleared information [2014-01-28]
- Consultation - A Revised Approach to NHP Site Licensing [2014-01-23]
- Natural Health Products Directorate (NHPD) six-month calendar of activities: January to June 2014 [2010-01-15]
- Updated - Natural health products online system standard terminology guide [2014-01-10]
- Natural Health Product Licence Application Form User Manual [2014-01-10]
- Guidance document on how to interact with the Natural Health Products Directorate electronically [2014-01-06]
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