The Drug Establishment Licensing Bulletin
The Health Product Compliance Directorate (HPCD) within the Regulatory Operations and Enforcement Branch oversees the national compliance and enforcement program for health products. HPCD manages the risk that health products pose to public health and safety in a number of ways. We provide:
- compliance promotion activities
- drug establishment licensing
- good manufacturing practice inspections
- compliance, investigation and enforcement
- health product shortage reporting and mitigation
Through compliance promotion activities, we strive to prevent problems from occurring in the first place by:
- raising awareness and educating regulated parties about their obligations under the Food and Drugs Act
- providing information to consumers to help them make well-informed health product choices
To help with these efforts we send Drug Establishment Licensing (DEL) Bulletins regularly to our stakeholders. These DEL Bulletins give information on our regulatory activities, process changes and hot issues.
The table below lists all of the DEL Bulletins that have been sent out to date. If a specific bulletin is not available for viewing, you can ask for a copy by emailing us at hc.del.questions-leppp.sc@canada.ca. Be sure to give us the bulletin number, date and title of the ones you would like to receive.
Stakeholders will continue to receive notifications by email when a new bulletin is available for viewing.
| Bulletin number | Title | Date |
|---|---|---|
| 171 | New guide to validation of terminal sterilization process of drugs (GUI-0074) | 2024-11-12 |
| 179 | New version of Annex 2 to the Good manufacturing practices guide – Manufacture of biologics (GUI-0027) | 2024-07-04 |
| 176 | Health Canada updates guidance on nitrosamine impurities in medications | 2024-04-30 |
| 175 | Drug quality and shortage and discontinuation reporting requirements in light of shipping disruptions | 2024-04-29 |
| 174 | Approach for renewing foreign buildings with expired new evidence required by (NERBY) dates | 2024-07-09 |
| 172 | Annex 4 to the current edition of the good manufacturing practices guidelines for veterinary drugs (GUI-0012) | 2024-05-03 |
| 170 | New memorandum of understanding with Australia | 2024-03-01 |
| 169 | Consultation on updates to sections of drug and natural health product documents | 2024-03-01 |
| 168 | Launch of a pilot good manufacturing practice single inspection program | 2024-02-27 |
| 167 | Guidance on Veterinary Antimicrobial Sales Reporting | 2024-02-22 |
| 166 | Health Canada's approach to foreign building name and addresses listed on the drug establishment licence | 2024-06-06 |
| 165 | Consultation open for foreign building compliance with drug good manufacturing practices (GUI-0080) | 2024-02-14 |
| 164 | Consultation opens for Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials (GUI-0036) | 2024-03-21 |
| 163 | Regulatory requirements prior to distributing Canadian drugs outside Canada | 2024-01-08 |
| 162 | Health Canada outlines plan for the future of DEL and GMP flexibilities | 2024-01-09 |
| 161 | Health Canada updates guidance on nitrosamine impurities in medications | 2024-01-12 |
| 160 | Drug quality and supply chain requirements in light of foreign conflict | - |
| 158 | What we heard report on improving access to drugs and other health products in Canada | - |
| 157 | Changes to the good manufacturing practices inspection program | 2024-01-05 |
| 155 | Extension to the timelines for completing changes to the market authorization (Step 3) | - |
| 154 | An updated nitrosamines guidance has been published online | - |
| 153 | BC port strike: Assessing drug shortage impact | - |
| 152 | Ongoing wildfires affecting various parts of the country | - |
| 151 | Consultation extension: Improving access to drugs and other health products | - |
| 156 | Consultation opened for guidance on applications and service standards (GUI-0127) | 2023-12-05 |
| 148 | Publication of updated Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs – GUI-0119 | 2023-08-24 |
| 149 | Consultation opens for guidance on good manufacturing practices for medical gases (GUI-0031) | 2023-06-16 |
| 134 | Updates to good manufacturing practices inspection policy for drug establishments | - |
| 135 | Annex 7 to the good manufacturing practices guide, selected non-prescription drugs (GUI-0066) | 2023-09-29 |
| 136 | Amendments to List of Non-Prescription Drugs incorporated by reference, CUSMA Implementation Act | - |
| 137 | Extended consultation for Annex 4 to the Good manufacturing practices guide – Veterinary drugs (GUI-0012) | - |
| 138 | New regulatory requirements for exports and transhipments of drugs | - |
| 139 | New version of Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026) | 2024-07-04 |
| 140 | Updates to guidance for evaluating and managing the risks of N-nitrosamine impurities in products | - |
| 141 | Consultation opens for the Good manufacturing practices guide: Manufacture of biologics (GUI-0027) | 2023-09-20 |
| 142 | Consultation round for GUI-0046 | 2024-09-10 |
| 143 | Canada and the United Kingdom officially recognize extra-jurisdictional good manufacturing practices inspections | 2024-01-05 |
| 144 | Key updates to the structure and issuance of drug establishment licences (DELs) | - |
| 145 | Extension requests for the confirmatory testing of nitrosamine impurities in DIN products | - |
| 146 | Updates to guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024) | 2023-03-27 |
| 147 | Guidance on veterinary antimicrobial sales reporting | 2023-03-13 |
| 84 | Guidance on business impact mitigation and additional measures for operational relief amid COVID-19 | 2020-04-16 |
| 124 | Announcement of webinars for GUI-0028 and GUI-0029 | 2022-01-27 |
| 133 | New guidance for evaluating and managing the risks of N-nitrosamine impurities in products | 2022-04-07 |
| 132 | Changes to policy on drug good manufacturing practices and DEL enforcement (POL-0004) | 2022-04-01 |
| 131 | Drug quality and supply chain requirements in light of Russia's invasion of Ukraine | 2022-03-28 |
| 130 | Guidance on veterinary antimicrobial sales reporting | 2022-03-14 |
| 129 | Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages | 2022-02-21 |
| 128 | Webinar for Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104) | 2022-02-15 |
| 125 | Notice of publication: Good manufacturing practices guidelines for active pharmaceutical ingredients | 2022-02-11 |
| 123 | Update to the drug establishment licence application form and process | 2022-07-12 |
| 122 | Modernizing the Medical Device & Drug Establishment Licensing Framework (Phase I) | 2021-12-14 |
| 121 | ICMRA Reflections on the regulatory experience of remote approaches to GMP and GCP regulatory oversight during the COVID-19 Pandemic | 2021-12-13 |
| 120 | New regulatory provisions for distributing Canadian drugs outside Canada and providing information related to drug shortages | 2021-11-23 |
| 119 | Introducing the new DEL Bulletin Webpage | 2021-08-12 |
| 118 | Notice of Publication - GUI-0050 | 2021-08-10 |
| 117 | Health Canada transitions interim order to the FDR for importing, selling, and advertising drugs in relation to COVID-19 | 2021-08-05 |
| 116 | Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021 | 2021-07-07 |
| 115 | Notice of Publication (GUI-0028 and GUI-0029) | 2021-07-02 |
| 114 | Notice of consultation for regulatory amendments supporting export-only drugs and transshipments | 2021-06-18 |
| 113 | Requirements to notify or report to Health Canada | 2021-04-11 |
| 112 | Consultation GUI-0074, process validation: Terminal sterilization processes for drugs | 2021-05-03 |
| 111 | Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes after March 31, 2021 | 2021-04-22 |
| 110 | Veterinary antimicrobial sales reporting | 2021-03-04 |
| 109 | Changes to the drug establishment licence exemptions for hand sanitizers | 2021-03-02 |
| 108 | Reminder: Cost-benefit analysis survey on proposed regulations due March 1, 2021 | 2021-02-18 |
| 107 | CETA Regulatory Cooperation Forum – Stakeholder debrief meeting, February 10, 2021 | 2021-02-01 |
| 106 | Health Canada nitrosamines webinar, February 10, 2021 | 2021-01-15 |
| 105 | Transition measures for exceptional importation interim order | 2021-01-25 |
| 104 | Invitation stakeholder information session on the allocation of drugs accessed via exceptional importation | 2021-01-19 |
| 103 | Nitrosamine update to market authorisation holders of human pharmaceutical, biological and radiopharmaceutical products | 2020-12-16 |
| 102 | Consultation on the recommendations for interoperability of track and trace systems for medicines | 2020-12-15 |
| 101 | Brexit: Summary information for Canadian companies | 2020-12-03 |
| 100 | New interim order - Safeguarding the drug supply | 2020-12-03 |
| 99 | New COVID hold for certain DEL applications | 2020-11-13 |
| 98 | Health Canada is adding tools to help prevent and alleviate drug shortages related to the COVID-19 pandemic | 2020-10-28 |
| 97 | Notice of consultation (GUI-0026) | 2020-10-07 |
| 96 | Electronic issuance of pharmaceutical product and good manufacturing practices certificates | 2020-10-01 |
| 95 | New pathway to expedite the authorization for importing, selling and advertising of COVID-19 drugs | 2020-09-21 |
| 94 | Notice of publication (GUI-0066 and GUI-0069) | 2020-08-25 |
| 93 | Notice of webinar (GUI-0069) | 2020-08-13 |
| 92 | Guidance: Importing and exporting health products for commercial use (GUI-0117) | 2020-08-13 |
| 91 | Extension revised to complete risk assessments for nitrosamine impurities | 2020-08-10 |
| 90 | Notice of publication (GUI-0005) | 2020-08-20 |
| 89 | Coming into force of regulatory amendments (CUSMA) (June 30, 2020) | 2020-06-30 |
| 88 | Enhanced guidance to support submission of proposals for inclusion on List of Drugs for Exceptional Import and Sale | 2020-06-25 |
| 87 | Updated question and answer document regarding nitrosamine impurities | 2020-06-12 |
| 86 | Guidance on transportation and storage considerations | 2020-05-15 |
| 85 | Requests for Information on additional supply of certain drugs used in the treatment of COVID-19 | 2020-04-22 |
| 83 | Health Canada COVID-19 update for health product licence holders | 2020-04-09 |
| 82 | Health Canada is taking action to quickly respond to potential drug shortages during the COVID-19 pandemic | 2020-04-06 |
| 81 | Electronic issuance of drug establishment licences | 2020-04-02 |
| 80 | Revised drug establishment licences (DEL) guides and form | 2020-04-01 |
| 79 | Information to market authorization holders (MAHs) of human pharmaceutical products regarding nitrosamine impurities | 2020-03-27 |
| 78 | Health product inspections and licensing blog | 2020-03-27 |
| 77 | Health Canada alleviates confirmatory and identity testing requirements for certain low-risk non-prescription drugs | 2020-03-26 |
| 76 | Canada announces interim drug product testing measures for licensed importers | 2020-03-23 |
| 75 | Approach to management of COVID-19 | 2020-03-17 |
| 74 | COVID-19 disinfectants and hand sanitizers | 2023-02-16 |
| 73 | Cost associated with foreign on-site assessments | 2020-03-06 |
| 72 | Notice of consultation (Annex 1) | 2020-02-20 |
| 71 | Important reminders (environmental crisis coronavirus) | 2020-02-19 |
| 70 | Notice of consultation - Annex 4 to the good manufacturing practices guide – Veterinary drugs (GUI-0012) | 2020-02-19 |
| 69 | Small business training session | 2020-02-19 |
| 68 | ALR webex links | 2020-02-05 |
| 67 | Health Canada stakeholder information webinar - Nitrosamines in pharmaceuticals, January 31, 2020 | 2020-01-24 |
| 66 | Introduction of telecommunication tools during GMP inspections | 2020-01-17 |
| 65 | CETA Regulatory Cooperation Forum - Stakeholder debrief meeting, February 4, 2020 | 2020-01-16 |
| 64 | Follow-up to letter to drug establishment licence (DEL) holders to inform them about steps to take to avoid nitrosamine impurities | 2019-12-05 |
| 63 | Notice of consultation PIC/S GMP guide | 2019-12-02 |
| 62 | Management of applications and performance for drug establishment licences (GUI-0127) | 2019-11-29 |
| 61 | Training sessions on revised guidance documents related to the Fees in Respect of Drugs and Medical Devices Order | 2019-12-29 |
| 60 | Canada-EU CETA Civil Society Forum call for participation | 2019-11-06 |
| 59 | Migration of drug establishment licence (DEL) API foreign building data to the DEL database | 2019-11-06 |
| 58 | Terms and conditions relating to angiotensin II receptor blockers (ARBs), known as "sartans" | 2019-11-06 |
| 57 | Letter to market authorization holders of human pharmaceutical products to inform on steps to take to avoid nitrosamine impurities | 2019-11-06 |
| 56 | Transition period for new DEL requirements for active pharmaceutical ingredients (API) for veterinary use | 2019-11-05 |
| 55 | Revised fees for drugs and medical devices | 2019-05-17 |
| 54 | Survey on Canadian drug exportation | 2019-05-02 |
| 53 | Certificate of pharmaceutical product & good manufacturing practice certificate annual fee increase | 2019-04-10 |
| 52 | Health Canada's fees for drugs and medical devices | 2019-04-01 |
| 51 | Best practices for submitting drug establishment licence (DEL) applications | 2019-03-22 |
| 50 | Stakeholder webinar presentation on the expanded sunscreen pilot | 2019-02-18 |
| 49 | Annual licence review webinar presentation and recording | 2019-01-30 |
| 48 | Pause-the-clock proposal webinar presentation and recording | 2019-01-26 |
| 47 | Additional Information regarding the expanded sunscreen pilot | 2019-01-22 |
| 46 | Presentation and recording on GUI-0031 webinar | 2019-01-11 |
| 45 | Notice to stakeholders – Release of good manufacturing practices for active pharmaceutical ingredients (GUI-0104) for consultation | 2018-12-31 |
| 44 | DEL annual licence review webinar | 2018-12-21 |
| 43 | Notice of consultation GUI-0069 | 2018-12-20 |
| 42 | Notifying Health Canada of foreign actions - Guidance document for industry | 2018-12-19 |
| 41 | Launch of the expanded sunscreen pilot | 2018-11-29 |
| 40 | Webinar stop-the-clock | 2018-11-28 |
| 39 | Notice of consultation GUI-0028 & GUI-0029 | 2018-11-21 |
| 38 | Call of expression of interest | 2018-11-14 |
| 37 | Technical issue with the Drug & Health Product Inspection Database | 2018-11-07 |
| 36 | Inclusion of API in Australia-Canada Mutual Recognition Agreement | 2018-11-01 |
| 35 | Pause-the-clock proposal for drug and medical device establishment licence applications | 2018-10-18 |
| 34 | Introducing new blog | 2018-10-15 |
| 33 | Important reminders – Hurricane Florence | 2018-09-27 |
| 32 | Health Minister announces access to a U.S.-approved epinephrine auto-injector | 2018-09-04 |
| 31 | Stakeholder engagement seminars (GUI-0001) | 2018-09-04 |
| 30 | Notice of publication – GUI-0071 | 2018-07-10 |
| 29 | Notice of consultation – GUI-0071 | 2018-07-05 |
| 28 | Licensing requirements for reclassified high-level disinfectants and sterilants as medical devices | 2018-07-23 |
| 27 | Webinar GUI-0001 | 2018-06-01 |
| 26 | Revised fee proposal for drugs and medical devices | 2018-05-25 |
| 25 | Important notice to stakeholders regarding revisions of drug establishment licensing guidance documents and forms as a result of amendments to the Food and Drug Regulations | 2018-05-22 |
| 24 | Antimicrobial regulatory amendment webinars affecting veterinary drugs – Drug establishment licensing and good manufacturing practices requirements | 2018-03-29 |
| 23 | GUI-0031 webinar | 2018-03-15 |
| 22 | Notice of publication | 2018-02-18 |
| 21 | Antimicrobial regulator amendment webinars affecting veterinary drugs – Health Canada | 2018-02-07 |
| 20 | GUI-0080 | 2018-01-09 |
| 19 | Notice of consultation | 2017-12-22 |
| 18 | Pilot for sunscreen products | 2017-12-21 |
| 17 | Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients | 2017-11-29 |
| 16 | Important reminders – Puerto Rico | 2017-10-04 |
| 15 | Importation of drugs for an urgent public health need | 2017-07-05 |
| 14 | Change to the Health Canada website | 2017-06-08 |
| 13 | Publication of Proposed Regulations Amending the Food and Drug Regulations (Vanessa's Law) in Canada Gazette, Part I [2017-05-05] | 2017-05-05 |
| 12 | Publication of proposed regulations amending the Food and Drug Regulations (importation of drugs for an urgent public health need) in Canada Gazette, Part I | 2017-05-02 |
| 11 | Certificate of pharmaceutical product and good manufacturing practice certificate annual fee increase | 2017-03-31 |
| 10 | Annual licence review product list | 2017-02-03 |
| 9 | Launch of the new pilot for sunscreen products | 2017-01-27 |
| 8 | Notice of consultation | 2017-01-18 |
| 7 | Implementation of a new pilot for sunscreens | 2016-12-22 |
| 6 | Reminder: Active pharmaceutical ingredient (API) application screening as of November 8, 2016 | 2016-11-08 |
| 5 | Reminder: Table B for active pharmaceutical ingredients (APIs) | 2016-11-08 |
| 4 | Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients | 2016-11-04 |
| 3 | Important notice to stakeholders regarding drug establishment licence applications submitted on portable storage devices | 2016-09-20 |
| 2 | Good manufacturing practices requirements for foreign buildings conducting activities in relation to active pharmaceutical ingredients destined for Canada or used to fabricate finished dosage forms destined for Canada | 2016-08-04 |
| 1 | Changes to the application process related to foreign buildings listed on drug establishment licences | 2016-07-21 |
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